July 23, 2025

Sandoz Inc. Issues Voluntary Nationwide Recall Expansion of One Additional Lot of Cefazolin for Injection Due to Vials Being Potentially Mislabeled as Penicillin G Potassium for Injection

Sandoz, Inc. (“Sandoz”) is initiating a voluntary nationwide recall expansion of one additional lot of Cefazolin for Injection, USP, 1 gram per vial. The lot is being recalled due to a customer complaint indicating that four (4) vials incorrectly labeled as Penicillin G Potassium for Injection, USP,    20 million Units were included in cartons (25 vials per carton) of Cefazolin for Injection, USP 1 gram per vial product. Sandoz has confirmed that the vials incorrectly labelled as Penicillin G Potassium for Injection contain Cefazolin for Injection, USP, 1 gram per vial.

There is a reasonable probability that the inadvertent administration of cefazolin injection following dosing recommendation of penicillin G potassium injection due to mislabeling may pose serious and potentially life-threatening adverse health consequences, including lack of efficacy leading to less than optimal treatment of severe infections, antibiotic resistance, adverse reactions, severe allergic reactions (e.g., anaphylaxis), drug interactions, and delayed recovery.

To date, Sandoz has not received any reports of adverse events or injuries related to the product mislabeling. Sandoz has received a complaint of administration of the incorrectly labeled product to a patient.

Sandoz is notifying its customers by letter and is arranging for return of the recalled product. The product being recalled was shipped to select wholesalers for further distribution nationwide. Healthcare providers and customers who have this product should immediately stop use of this lot only and contact Sedgwick, the Sandoz Reverse Distributor, directly by phone at (844) 265-7409 or by email at Sandoz5615@sedgwick.com.

Nostrum Laboratories, Inc. Issues Voluntary Nationwide Recall of Sucralfate Tablets USP 1 Gram Within Expiry

Nostrum Laboratories, Inc. (“Nostrum Labs”) filed Chapter 11 bankruptcy on September 30, 2024. In connection with that filing, the company has ceased and shutdown operations and terminated its operational employees at all domestic U.S. sites. Nostrum Labs is initiating a voluntary recall of Sucralfate Tablets USP 1 gram, all lots within expiry, as a result of the closures and discontinuation of its Quality activities.

This recall pertains only to Sucralfate Tablets USP 1 gram, all lots with expiry, manufactured by Nostrum Labs after June 2023. No other Nostrum Labs products are affected by this recall. Nostrum Labs distributed the product at issue here to wholesalers, retailers, manufacturers, medical facilities, and repackagers.

It cannot be guaranteed that any lots of this product that are still within expiry will meet all intended specifications through the labeled shelf life of the product. Further distribution or use of any remaining product on the market should cease immediately.

Nostrum Labs is notifying its distributors and direct consignees for this product by email and U.S. mail and is requesting they immediately further notify their subsidiaries, individual receiving sites or warehouses, customers, retailers, and consumers. All lots of this product should be destroyed; Nostrum Labs is not accepting any returns of this product.

The discontinuation of Nostrum Labs’ quality program means that the Company is unable to assure that this product meets the identity, strength, quality, and purity characteristics that it is purported or represented to possess. While specific risks to patients from use of an adulterated product cannot always be identified or assessed, it is also not possible to rule out patient risks resulting from the use of such a product. Nostrum Labs has not received any reports of adverse events related to this recall.

Customers with questions regarding this recall can contact Nostrum Labs at recallcoordinator@nostrumlabsrecall.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

June 5, 2025

Amneal Pharmaceutical Issues Nationwide Recall of  Sulfamethoxazole / Trimethoprim Tablets, USP, 400 mg/80mg Due to Microbial Contamination

Amneal Pharmaceutical LLC,   is recalling three lots of Sulfamethoxazole/Trimethoprim Tablets, USP, 400 mg/80 mg to the consumer level as the tablets may exhibit black spots on the tablet surface due to microbial contamination. The observance of black spots was reported in a product quality complaint.

Oral products contaminated with Aspergillus may result in serious and life-threatening infections. The use of the defective product in patients with underlying immunosuppressive conditions increases the concern for serious infections. To date, Amneal Pharmaceuticals has received no reports of adverse events, illnesses or injuries related to this recall.

The recalled product was distributed nationwide to wholesalers/distributors between the dates of 12/4/2024 and 5/15/2025.

This recall pertains only to the   400 mg/80  mg strength  and only to the listed lots below.

Retailers are being asked to notify their customers and instruct consumers to contact Amneal Pharmaceuticals directly for assistance with return of any recalled product and reimbursement information.

Individuals with questions regarding this recall can contact Amneal Pharmaceuticals by: 

• Phone: 833-582-0812, Monday - Friday, 8 am - 5 pm, EST
• Fax: 631-983-2595
• E-mail to: sulfamethoxazole-trimethoprim-recall@amneal.com

For Medical Inquiries or to report Adverse Events or quality problems experienced with the use of this product, please contact Amneal Drug Safety by phone at 1-877-835-5472, Monday - Friday, 8 am - 6 pm, EST, or email at   DrugSafety@amneal.com. 

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.  Complete and submit the report Online.

February 17, 2025

ICU Medical issues nationwide Recall of Potassium Chloride Injection, 20 mEq and Potassium Chloride Injection, 10 mEq due to mislabeling

ICU Medical has identified a potential for some of the product overwraps in one lot being mislabeled as 10 mEq of POTASSIUM CHLORIDE  (instead of 20 mEq that is contained in the I.V. bag)  due to a manufacturing issue. The 20 mEq, correctly printed on the labeling affixed to the bag, is not visible or not easily visible without manipulation when the 10 mEq overwrap is in place.

Risk Statement: If the health care provider mistakenly calculates the patient dose using 10 mEq, the patient will receive an overdose of potassium chloride. Severe hyperkalemia after large intravenous overdoses causes neuromuscular dysfunction including muscle weakness, ascending paralysis, listlessness, vertigo, mental confusion, hypotension, cardiac dysrhythmias or death from cardiac arrest. Premature infants, patients on chronic parenteral nutrition, patients who have a history of cardiac arrythmias, patients with chronic renal insufficiency, patients who have acute renal failure, patients on potassium-sparing diuretics, are all at risk for adverse and potentially fatal outcomes.

The mislabeled POTASSIUM CHLORIDE Inj. 20 mEq, 100 mL bags contain incorrect overwrap labels with the following information: NDC 0990-7074-26, 200 mEq/L POTASSIUM CHLORIDE Inj. 10 mEq. The lot 1023172 and Exp. Date 31 January 2026 is found on the primary container. These mislabeled bags are packaged in cases labeled: NDC 0990-7075-26, CASE PACK 1x24 – 100ML 20MEQ POTASSIUM CHLORIDE INJECTION LOT NO. 1023172, EXP DATE 2026-01.

December 31, 2024

Astellas Pharma US, Inc., issues voluntary nationwide recall of one lot of PROGRAF® 0.5mg (tacrolimus) and one lot of ASTAGRAF XL® 0.5mg (tacrolimus extended-release capsules) because bottles shipped to U.S. may contain empty capsules

Astellas Pharma US, Inc.. is voluntarily recalling one lot of PROGRAF® 0.5mg (tacrolimus) and one lot of ASTAGRAF XL® 0.5mg (tacrolimus extended release) capsules to the consumer level. These products are being recalled because bottles may contain empty capsules.

Transplant patients who consume empty PROGRAF or ASTAGRAF XL capsules may experience initiation of rejection of the transplanted organ, tissue or cells, due to underimmunosuppression. In the case of life sustaining organ transplants such as a heart transplant (for which there is no permanent substitute such as hemodialysis in the case of a failed kidney transplant) if the transplant fails, the consequences of rejection initiated by ingesting empty capsules may be fatal. To date, Astellas has not received any reports of adverse events related to this recall.

PROGRAF and ASTAGRAF XL are immunosuppressive medicines used in conjunction with other medicines to help prevent organ transplant rejection. PROGRAF is used in people who have had kidney, heart, liver or lung transplants and ASTAGRAF XL is indicated for use in people with kidney transplants.

The affected lot numbers and expiration dates are:

No other formulations or doses of the product are impacted, and sufficient supply of unaffected stock is available to replace the recalled lots. The product was distributed nationwide to wholesale and retail outlets.

Patients that have an affected lot should contact their physician or health care provider. Patients and physicians with questions should contact Astellas Medical Information at 1-800-727-7003 during office hours from 9 a.m. to 5:30 p.m. EST, Monday through Friday.

November 25, 2024

Endo expands voluntary recall of Clonazepam Orally Disintegrating Tablets, USP (C-IV) due to potential product carton strength mislabeling

Endo, Inc. (OTCQX: NDOI) (“Endo”) announced today that one of its operating subsidiaries, Endo USA, Inc., is expanding its previously announced voluntary recall of Clonazepam Orally Disintegrating Tablets, USP (C-IV) due to potential product carton strength mislabeling.

Specifically, Endo’s ongoing investigation has identified the possibility that the Clonazepam product lots listed below contain a limited number of cartons printed with the incorrect strength and National Drug Code (NDC) due to an error by a third-party packager. The blister strips and tablets inside the product pack reflect the correct strength for the lot.

The following table details the lots being added to the voluntary recall, including lot product description and NDC number.

Risk statement:
Children and adults who inadvertently consume a higher dose of clonazepam could be at increased risk for the adverse events of significant sedation, confusion, dizziness, diminished reflexes, ataxia and hypotonia. There is reasonable probability for significant, possibly life-threatening respiratory depression, especially for patients with concomitant pulmonary disease, patients who have prescribed dosing near maximal dosing and patients also taking other medications that could cause additional respiratory depression.

Clonazepam Orally Disintegrating Tablets are indicated alone or as an adjunct in the treatment of the Lennoz-Gastaut syndrome (petit mal variant), akinetic and myoclonic seizures. Additionally, the product is indicated for the treatment of panic disorder.

Package identification:
The product is packaged in cartons containing 60 tablets packed into 10 blister strips each containing 6 tablets. The carton and each blister strip pocket are printed with the name, strength, lot number, expiration date and NDC number. The packaging lists the legacy company Par Pharmaceutical which previously marketed Clonazepam before the product was acquired by Endo.

Action Required:
The product lots were distributed through wholesale distributors to retail pharmacies nationwide.

Endo is providing written notification to wholesale accounts and retailers that have received the product lots and is arranging for the return of all existing inventory through Inmar, Inc.

Distributors/retailers that have the product lot being recalled should immediately stop distributing and dispensing, and return to the place of purchase or contact Inmar on the below telephone line.

Consumers in possession of any unused prescribed tablet cartons of Clonazepam Orally Disintegrating Tablets, USP bearing the above lot numbers have been advised to discontinue use of the product.

If a patient inadvertently took an incorrect dose rather than the intended dose, they are advised to consult a physician.

Consumers with questions regarding this recall can contact Inmar by telephone at 855-589-1869 (Monday through Friday, 9 a.m. to 5 p.m. ET) or by email at rxrecalls@inmar.com.

This product lot recall is being made with the Food and Drug Administration’s (FDA’s) knowledge.

September 27, 2024

The FDA is alerting patients and health care professionals about the voluntary withdrawal of Oxbryta from the market due to safety concerns

The FDA is alerting patients, caregivers and health care professionals that Oxbryta (voxelotor) is being voluntarily withdrawn from the market by the manufacturer due to safety concerns. Health care professionals should stop prescribing Oxbryta.

Pfizer Inc., the manufacturer of Oxbryta, announced it is voluntarily withdrawing the medication from the market, ceasing distribution, and discontinuing all active clinical trials and expanded access programs for Oxbryta because recent data indicate the benefit of Oxbryta does not outweigh the risks for the sickle cell patient population.

In post-marketing clinical trials of Oxbryta, Pfizer reported a higher rate of vaso-occlusive crisis (severe pain caused by sickled red blood cells blocking blood flow and oxygen delivery to tissues) in patients with sickle cell disease receiving Oxbryta compared to the placebo. There were also more deaths in the Oxbryta treatment group as compared to the placebo group in these post-marketing studies. Pfizer also observed a higher rate of vaso-occlusive crisis in patients with sickle cell disease receiving Oxbryta in two real-world registry studies. Based on the totality of clinical data, Pfizer has determined the benefit of Oxbryta does not outweigh the risk.

The FDA understands the importance of having safe and effective medications available to improve the health of patients living with this rare, serious disease. There are other FDA-approved medications for the treatment of sickle cell disease, which health care professionals may prescribe as an alternative treatment to Oxbryta.

The FDA encourages health care professionals and patients to report adverse events or quality problems experienced with the use of Oxbryta to the FDA’s MedWatch Adverse Event Reporting program by:

• Completing and submitting the report online at www.fda.gov/medwatch/report.htm;
  or
  
• Downloading and completing the form, then submitting it via fax at 1-800-FDA-0178.

September 25, 2024

Bionpharma Inc., issues voluntary nationwide recall of Atovaquone oral suspension due to bacterial contamination

Bionpharma Inc., is voluntarily recalling one single Batch (2310083) of Atovaquone oral suspension, 750mg per mL to the consumer level. The product was manufactured by CoreRx, Inc., in Clearwater, FL, and distributed by Bionpharma Inc. The product was found to be contaminated with Cohnella bacteria.

Risk Statement: In the population most at risk, the immunocompromised population, there is a reasonable probability that microbial contamination of Atovaquone oral suspension can result in disseminated, life-threatening infections such as inflammation of the heart and permanent damage to soft tissue. To date, Bionpharma has not received any reports of adverse events related to this recall.

This product is a quinone antimicrobial drug indicated for prevention of pneumocycstis jirovecii pneumonia (formerly known as PCP for pneumocystis carinii pneumonia) in adults and adolescents age 13 and older. The affected batch of product was manufactured at CoreRx, Inc., and shipped nationwide to our customers between December 21, 2023 and June 20, 2024 and distributed through wholesalers and retailers.

The lot number can be obtained from the side panel of the bottle or the bottom flap of the carton.

The company is notifying its distributors and customers by email and is arranging for return/replacement, etc. of the recalled batch of the product. Distributors/retailers that have the affected lot of the drug product which is being recalled should immediately cease distribution and remove it from active inventory. Consumers that have the affected lot of the product should stop using the product and return it to the place of purchase.

Consumers with questions regarding this recall can contact Bionpharma by phone at 1-888-235-2466 (Monday - Friday 9:00 a.m. - 5:00  p.m. EST) or email  drugsafety@bionpharma.com. Consumers should contact their physician or health care provider if they have experienced any problems that may be related to taking or using the affected lot of the drug product.

September 25, 2024

Gilead issues voluntary nationwide recall of one lot of Veklury® (remdesivir) for injection 100 mg/vial due to the presence of a glass particle

Gilead Sciences, Inc., announced it is issuing a voluntary recall of one lot of Veklury® (remdesivir) for injection 100 mg/vial, to the consumer level. Gilead received a customer complaint and confirmed the presence of a glass particle in the vial during the company's investigation.

The administration of an injectable product that contains glass particles may result in local irritation or swelling in response to the foreign material. The glass particulate can potentially travel through the blood vessels to various organs and block blood vessels in the heart, lungs or brain which can cause stroke and even lead to death. To date, Gilead has not received any reports of adverse events related to this recall.

Veklury® (remdesivir) for injection 100 mg/vial is indicated for the treatment of COVID-19 in adults and pediatric patients (birth to less than 18 years of age weighing at least 1.5 kg) who are:

• Hospitalized; or
• Not hospitalized and have mild-to-moderate COVID-19 and are at high risk for progression to severe COVID-19, including hospitalization or death

Veklury® (remdesivir) for injection 100 mg/vial may only be administered in settings in which health care providers have immediate access to medications to treat a severe infusion or hypersensitivity reaction, such as anaphylaxis, and the ability to activate the emergency medical system (EMS), as necessary.

Consumers and health care providers with questions regarding this recall can contact Gilead Medical Information at 1-866-633-4474, Monday  - Friday, 5:00 a.m. - 6:00 p.m. PST or through their website at www.askgileadmedical.com. Consumers should contact their physician or health care provider if they have experienced any problems that may be related to taking or using this drug product.

September 13, 2024

Continuous glucose monitoring (CGM) sensor recall: Abbott Diabetes Care, Inc., issues recall of certain FreeStyle Libre 3 sensors due to risk of inaccurate high glucose readings

This recall involves removing certain devices from where they are used or sold, and does not apply to the FreeStyle Libre 3 reader or app. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use the affected lot numbers.

Affected product

• Product Name: FreeStyle Libre 3 sensor, a component of FreeStyle Libre 3 Continuous Glucose Monitoring System
• Lot Numbers: T60001948, T60001966, T60001969

What to do

• Users of FreeStyle Libre 3 sensors should follow the instructions below to check the sensor serial numbers to find out if the sensor is in the affected lot.
• Distributors of FreeStyle Libre 3 sensors should check their inventory to find out if there are any affected sensors left in their inventory.
• Immediately stop using and distributing any affected sensors.
• Throw affected sensors away.

Medical Device Recall recommending the following actions:

• Immediately discontinue use and dispose of any affected sensors.
• Request a replacement for any affected sensor(s) by visiting https://www.freestyleconfirm.com/us-en/home.htmlExternal Link Disclaimer.
  • Select “CONFIRM SENSOR SERIAL NUMBER” and enter a valid serial number.
  • Customers with impacted sensors will be instructed to enter contact information so a replacement product can be sent at no cost.
• If there are symptoms that do not match the sensor glucose reading or it is suspected that a glucose reading is inaccurate, check the reading by conducting a fingerstick test using any blood glucose meter.
  • The built-in blood glucose meter in the FreeStyle Libre 3 reader is not affected by this recall and may be used to check glucose at any time.

Reason for recall

Abbott Diabetes Care, Inc., is recalling these FreeStyle Libre 3 sensors after finding that a small number of FreeStyle Libre 3 sensors may provide incorrect high glucose readings which, if undetected, may pose a potential health risk for people living with diabetes.

The use of affected product may cause serious adverse health consequences, including severe low blood sugar (hypoglycemia) which can cause central nervous system problems, loss of consciousness, seizures, coma, permanent brain damage and death.

Contact Information

Customers in the U.S. with questions about this recall should contact Abbott Diabetes Care, Inc., customer service at 1-833-815-4273.

August 29, 2024

Baxter Issues Voluntary Nationwide Recall of One Lot of Heparin Sodium 0.9% Sodium Chloride Injection Due to Potential for Elevated Endotoxin Levels

DEERFIELD, IL, AUG. 5, 2024 –Baxter International Inc. (NYSE:BAX) is voluntarily recalling one lot of Heparin Sodium in 0.9% Sodium Chloride Injection to the consumer level due to the potential for elevated endotoxin levels based on issues related to the bacterial endotoxin test specific to lot number N008235.

Use of heparin with higher than acceptable endotoxin levels may lead to significant adverse health consequences ranging from febrile reactions to toxic shock, multi-organ failure and death. To date, Baxter has not received any reports of adverse events related to this issue.

Heparin Sodium in Sodium Chloride Injection is indicated as an anticoagulant to maintain catheter patency and is packaged in 2,000 USP units, 1,000 mL in VIAFLEX Plus Plastic Container-1 unit per pouch. This issue affects one lot of product code that was distributed between March 12, 2023, and August 24, 2023, to healthcare facilities, wholesalers and distributors in the United States. The product code and lot number can be found on the individual product and shipping carton. See the product image below for more on where this information can be found.

• Product Code: 2B0944
• Product Description: Heparin Sodium in 0.9% Sodium Chloride Injection, 2,000 units per 1,000 mL
•   Lot Number:   N008235
• Expiry Date:   31-Aug-2024
• NDC Number:   0338-0433-04

Baxter voluntarily sent an Urgent Drug Recall communication to all impacted customers for the impacted lot and is arranging for the return of all affected product. Customers should follow the instructions in the Urgent Drug Recall letter to return the affected product. 
Customers with questions regarding this recall should contact Baxter Healthcare Center for Service at (888)-229-0001 between the hours of 7:00 am and 6:00 pm Central Time, Monday through Friday.

August 6, 2024

Endo USA, Inc. Issues Voluntary, Nationwide Recall of One Lot of Clonazepam Orally Disintegrating Tablets, USP (C-IV) Lot Number 550147301 Due to Mislabeling: Incorrect Strength on Product Carton

MALVERN, PA, July 16, 2024 – Endo, Inc (OTCQX: NDOI) (“Endo”), announced today that one of its operating subsidiaries, Endo USA, Inc., is voluntarily recalling one lot of Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.25 mg tablets, which may also appear as Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.125 tablets 60-count pack to the consumer level.

The product lot is being recalled due to mislabeling where an incorrect strength appears on the cartons of some packs to show the product strength as 0.125 mg and not 0.25 mg due to an error at a third-party packager. The blister strips inside the product pack reflect the correct strength of 0.25 mg.

Risk Statement: Children and adults who are inadvertently prescribed a two-fold overdose of clonazepam would be at risk for the adverse effects of significant sedation, dizziness, ataxia, and confusion. Endo has not received any reports of adverse events associated with this product lot recall. The product is packaged in cartons of 60 tablets; the package labels feature the product name, strength, lot number, and expiration date, and the National Drug Code (NDC) number 49884-307-02; impacted units will display the NDC code 49884-306-02. This recall impacts the following product lot:

• Clonazepam Orally Disintegrating Tablets, USP 0.25 mg 60-count carton, lot 550147301, expiration date August 2026
• Clonazepam Orally Disintegrating Tablets, USP 0.125 mg 60-count carton, lot 550147301, expiration date August 2026

Consumers in possession of any unused prescribed 60 tablet cartons of Clonazepam Orally Disintegrating tablets, USP 0.25mg which may also appear as Clonazepam Orally Disintegrating tablets USP 0.125mg bearing the lot number 550147301 have been advised to discontinue use of the product. Consumers with questions regarding this recall can contact Inmar by telephone at 877-890- 0765 (Monday through Friday, 9 a.m. to 5 p.m. ET) or by email at rxrecalls@inmar.com.

December 18, 2023

Novartis Issues Voluntary U.S. Nationwide Recall of Two Lots of Sandimmune® Oral Solution (Cyclosporine Oral Solution, USP), 100 mg/mL Due to Crystallization

Nov. 24, 2023 - East Hanover, NJ — Novartis is conducting a voluntary nationwide recall at the consumer level of two lots of its Sandimmune® Oral Solution (cyclosporine oral solution, USP), 100 mg/mL in the U.S. due to crystal formation observed in some bottles, which could potentially result in incorrect dosing. The issue was identified during an investigation of crystallization in a different lot of Sandimmune® Oral Solution (cyclosporine oral solution, USP), 100 mg/mL. No other Sandimmune formulations are impacted. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Sandimmune® Oral Solution (cyclosporine oral solution, USP), 100 mg/mL, packaged in 50 mL bottles, is indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. The drug may also be used in the treatment of chronic rejection in patients previously treated with other immunosuppressive agents.

Risk statement: Crystallization of cyclosporine in Sandimmune Oral Solution is likely to result in non-uniform distribution of the cyclosporine in the product, resulting in under-dosing or over-dosing. There is a reasonable probability that under-dosing may result in lower exposures and decrease in efficacy which could ultimately lead to graft rejection and graft loss in transplant patients. Furthermore, over-dosage may manifest itself as cyclosporine toxicity in the long term if over exposure continues. Novartis has not received any reports of adverse events related to this recall, to date.

The affected lot numbers and expiration dates are: FX001500 (expiration date 09/2024) and FX001582 (expiration date 09/2024) NDC 0078-0110-22. These lots were only distributed in the U.S. They were distributed nationwide to wholesalers across the U.S., beginning in January 2022 and September 2022, respectively.

Novartis is notifying its distributors via a recall notification letter and is arranging for return of the recalled lot from distributors, retailers and consumers. Additionally, Novartis is notifying health care providers who have prescribed this product to contact their patients. Consumers that have bottles from the recalled lot of Sandimmune Oral Solution (cyclosporine oral solution, USP), 100mg/mL should contact their health care provider.

In the event that a patient experiences an adverse reaction or quality problem involving this product, they should immediately contact their health care provider and Novartis to report the event or finding. Patients or health care providers may call the Novartis Customer Interaction Center at 888-NOW-NOVA (888-669-6682) from 8:30 a.m. - 5:00 p.m. ET Monday through Friday or may report an adverse event through https://www.novartis.com/reportExternal Link Disclaimer or usdrugsafety.operations@novartis.com.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online.
• Regular mail or fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the  form, or submit by fax to 1-800-FDA-0178.

December 18, 2023

Insight Pharmaceuticals Issues Voluntary Nationwide Recall of TING® 2% Miconazole Nitrate Athlete’s Foot Spray Antifungal Spray Powder Due to the Presence of Benzene

Tarrytown, NY, Nov. 24, 2023 (GlobeNewswire) —  Insight Pharmaceuticals, a Prestige Consumer Healthcare Inc. company (“Insight”), is voluntarily recalling two lots of TING 2% Miconazole Nitrate Athlete’s Foot Spray Antifungal Spray Powder to the consumer level. A recent review by our manufacturer and their third-party lab found that samples from two lots of the product contained elevated levels of benzene. While benzene is not an ingredient in any TING Antifungal Spray products, the review showed that unexpected levels of benzene came from the propellant that sprays the product out of the can. Importantly, no other lots of TING 2% Miconazole Nitrate Athlete’s Foot Spray Antifungal Spray Powder (either before or after these batch codes) and no other TING Antifungal Spray products are in the scope of this recall and may continue to be used by consumers safely and as intended.

Risk statement:  Benzene is classified as a human carcinogen. Exposure to benzene can occur by inhalation, orally and through the skin. It can  potentially result in cancers including leukemia and blood cancer of the bone marrow and blood disorders, which can be life threatening. Insight is recalling these products out of an abundance of caution. To date, the company has not received any serious adverse events related to this recall. Benzene is found in the environment; humans  can have daily exposures to it indoors and outdoors from multiple sources.

TING 2% Miconazole Nitrate Athlete’s Foot Spray Antifungal Spray Powder is packaged in green and white aerosol cans with lot codes located on the bottom of the can. Samples of the recalled lots below have been found to contain trace levels of Benzene related to the propellant that sprays the product out of the can. Benzene is not an ingredient in any TING products.

The affected TING 2% Miconazole Nitrate Athlete’s Foot Spray Antifungal Spray Powder lots were distributed nationwide in the United States through a limited number of retailers and online.

Insight has notified retailers via overnight mail to remove any remaining recalled product from shelves and follow the instructions provided in the Drug Recall Notification. The company will also offer reimbursement for consumers who have purchased TING 2% Miconazole Nitrate Athlete’s Foot Spray Antifungal Spray marked with one of the lot codes in the table above. Consumers can contact Insight Pharmaceuticals via e-mail at medicalaffairs@prestigebrands.com, through its website at https://www.prestigebrands.com/contactExternal Link Disclaimer, or by phone at 1-800-344-7239 from 8:30 a.m. - 5:30 p.m. ET Monday – Friday  to receive a full refund by providing a picture of the bottom of the can of the TING 2% Miconazole Nitrate Athlete’s Foot Spray Antifungal Spray with the affected lot number. Consumers that have product which is being recalled should stop using the product immediately and appropriately discard after taking the picture. No serious adverse events have been reported to date.

Consumers with questions regarding this recall can contact Insight Pharmaceuticals via e-mail at medicalaffairs@prestigebrands.com, through its website at https://www.prestigebrands.com/contactExternal Link Disclaimer  or by phone at 1-800-344-7239 from 8:30 a.m. - 5:30 p.m. ET Monday – Friday . Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this antifungal product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report online: www.fda.gov/medwatch/report.htm.
• Regular mail or fax: Download form at   www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the  form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

November 10, 2023

Cardinal Health, Inc. Issues Voluntary Nationwide Recall of Certain LEADER™ Brand Eye Drops Supplied by Velocity Pharma, LLC   Due to Potential Risk of Eye Infections

October 31, 2023 – Dublin, OH, Cardinal Health, Inc. is initiating a voluntarily recall for all lots of ophthalmic products supplied by Velocity Pharma, LLC to the consumer level. Cardinal Health, Inc. received information from the U.S. Food and Drug Administration (FDA) indicating investigators found insanitary conditions in the manufacturing facility and positive bacterial test results from environmental sampling of critical drug production areas in the facility. This recall is being conducted with the knowledge of the FDA.

Risk Statement: For those patients who use these products, there is a potential risk of eye infections that could result in partial vision loss or blindness. These products are intended to be sterile. Ophthalmic drug products pose a potential heightened risk of harm to users because a drug applied to the eyes bypasses some of the body’s natural defenses. To date, Cardinal Health, Inc., and its subsidiaries have received reports of three  adverse events related to these listed products. The reports of adverse events were shared with our supplier, Velocity Pharma, LLC.

These products are available as over the counter (OTC) products used for temporary relief of burning and irritation due to dryness of the eye, for use as a protectant against further irritation or to relieve dryness of the eye and/or to relieve redness of the eye due to minor eye irritations. Products were distributed nationwide to wholesalers and retailers starting December 12, 2021. These products can be identified on the outer carton labeling as follows:

Cardinal Health, Inc. is notifying all impacted direct accounts via mail of this voluntary recall and is arranging for return of all recalled products listed above. Wholesalers, distributors and retailers that have the affected product which is being recalled should cease distribution of the products. Consumers should stop using the recalled eye drop products and may return any of the above listed products to the place of purchase.

Consumers with questions regarding this recall can contact Sedgwick, Inc. by phone at 1-855-215-4940 (Monday through Friday  from 8:00 a.m. - 5:00 p.m. EST) or by email at   Cardinalhealth7720@sedgwick.com. Consumers who have signs or symptoms of an eye infection after using these products should talk to their health care provider or seek medical care immediately.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report online: www.fda.gov/medwatch/report.htm.

• Regular mail or fax: Download form at   www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form or submit by fax to 1-800-FDA-0178.
  

November 10, 2023

The Harvard Drug Group, LLC Issues Voluntary Nationwide Recall of Certain Rugby® Laboratories Brand Eye Drops Supplied by Velocity Pharma, LLC Due to Potential Risk of Eye Infections

October 31, 2023 – The Harvard Drug Group, LLC d/b/a Major® Pharmaceutical and Rugby® Laboratories is initiating a voluntary recall for all lots of Polyvinyl Alcohol, 1.4% Lubricating Eye Drops and Lubricating Tears Eye Drops (Dextran/Hypromellose, 0.1%/0.3%) supplied by Velocity Pharma, LLC to the consumer level. The Harvard Drug Group, LLC received information from the  U.S. Food and Drug Administration (FDA) indicating investigators found insanitary conditions in the manufacturing facility and positive bacterial test results from environmental sampling of critical drug production areas in the facility. This recall is being conducted with the knowledge of the FDA.

Risk Statement: For those patients who use these products, there is a potential risk of eye infections that could result in partial vision loss or blindness. These products are intended to be sterile. Ophthalmic drug products pose a potential heightened risk of harm to users because a drug applied to the eyes bypasses some of the body’s natural defenses. The Harvard Drug Group, LLC has received three reports of adverse events related to these products including reports of vision blurriness, vision loss and burning eyes. The reports of adverse events were shared with our supplier, Velocity Pharma, LLC.

Polyvinyl Alcohol, 1.4% Lubricating Eye Drops and Lubricating Tears Eye Drops (Dextran/Hypromellose, 0.1%/0.3%) are available as over the counter (OTC) products used for temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun and the product used as a protectant against further irritation or to relieve dryness of the eye. Products were distributed nationwide starting June 1, 2021. Both Polyvinyl Alcohol, 1.4% Lubricating Eye Drops and Lubricating Tears Eye Drops (Dextran/Hypromellose, 0.1%/0.3%) can be identified on the outer carton labeling as follows:

The Harvard Drug Group, LLC is notifying all impacted direct accounts via mail of this voluntary recall and is arranging for return of all recalled products listed above. Wholesalers, distributors and retailers that have the affected product which is being recalled should cease distribution of the products. Consumers should stop using the recalled eye drop products and may return any of the above listed products to the place of purchase.

Consumers with questions regarding this recall can contact Sedgwick, Inc. by phone at 1- 866-891-1981 (Monday through Friday 8:00 a.m. - 5:00 p.m. EST) or by email to   harvarddrug8430@sedgwick.com. Consumers who have signs or symptoms of an eye infection after using these products should talk to their health care provider or seek medical care immediately.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report online: www.fda.gov/medwatch/report.htm.
• Regular mail or fax: Download form at   www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form or submit by fax to 1-800-FDA-0178.

October 4, 2023

VistaPharm LLC Issues Voluntary Nationwide Recall of Sucralfate Oral Suspension, 1g/10mL Due to Microbial Contamination Identified as Bacillus Cereus

September 22, 2023 – Largo, Florida, VistaPharm LLC is voluntarily recalling one lot of Sucralfate Oral Suspension, 1g/10mL, to the consumer level, due to Bacillus cereus contamination in the product. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Risk Statement: In the population most at risk, the immunocompromised population, there is a reasonable probability that microbial contamination of the oral suspension can result in disseminated, life threatening infections such as endocarditis and necrotizing soft tissue infections. To date, VistaPharm LLC has not received any reports of adverse events related to this recall.

A contractor, Inmar, will perform this recall process, which is notifying its distributors by recall packet delivered by FEDEX Next Day Delivery and will receive an email notification as well. In addition, Inmar is arranging for the return of all recalled products. Distributors that have any bottles remaining from Sucralfate Oral Suspension Lot 810300, which is being recalled, should return them to Inmar via the instructions provided.

Consumers with questions regarding this recall can contact Inmar by phone at 1-800-967-5952 or by email at   rxrecalls@Inmar.com.   Office hours 9 a.m. to 5 p.m. EST Monday through Friday. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online
• Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
  

August 31, 2023
Dr. Berne’s Whole Health Products Issues Voluntary Nationwide Recall of Dr. Berne’s MSM Drops 5% and 15% Solution Eye Drops Due to Bacterial and Fungal Contamination

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. Dr. Berne’s Whole Health Products is voluntarily recalling all lots of MSM Drops 5% and 15% Solution, Dr. Berne’s Organic Castor Oil Eye Drops and Dr. Berne’s MSM Mist 15% Solution to the consumer level. FDA analysis has found one lot (lot 6786) of Dr. Berne's MSM Drops 5% Solution to fail sterility with both bacterial and fungal contamination found in the product. Out of an abundance of caution, Dr. Berne's is recalling all other lots of the 5% and 15% strengths of MSM Solution and all lots of Dr. Berne’s Organic Castor Oil Eye Drops and Dr. Berne’s MSM Mist 15% Solution.

Risk Statement: Using contaminated eye drops could result in minor to serious vision-threatening infection which could possibly progress to a life-threatening infection. To date, Dr. Berne’s has received 2 reports of adverse events related to this recall.

These products are used as  lubricating eye drops and are packaged in 30 ml/1.014 oz. plastic bottles. The product Dr. Berne’s Organic Castor Oil Eye Drops is packaged in a 30 mL/1fl oz. white plastic bottle; Dr. Berne’s MSM Mist 15% Solution is packaged in a 30mL/1.014 oz. white bottle. All these affected products were distributed through Dr. Berne’s webstore.

Dr. Berne’s is notifying its distributors and customers by e-mail and arranging for return of its MSM Drops 5% and 15% Solution and Dr. Berne’s Organic Castor Oil Eye Drops and Dr. Berne’s MSM Mist 15% Solution. Consumers/distributors/retailers that have product which is being recalled should stop using and return to Sun Star Organics, 988 Main Street, Orange, CA 92867.

Consumers with questions regarding this recall can contact Dr. Berne’s Whole Health Products at 1-877-239-3777 or by e-mail at hello@drsamberne.com, Mon. - Fri. from  9:00 - 5:00 p.m. Mountain Time. Consumers should contact their physician or health care provider if they have experienced any problems that may be related to using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online
• Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

August 21, 2023

Lupin Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of 2 Lots of Tydemy™ (Drospirenone, Ethinyl Estradiol and Levomefolate Calcium Tablets 3mg/0.03mg/0.451mg and Levomefolate Calcium Tablets 0.451mg) Due to Out of Specification (OOS) Results at the 12-month Stability Time Point

Baltimore, Maryland, July 28, 2023: Lupin Pharmaceuticals Inc. (Lupin) is voluntarily recalling two lots of Tydemy (Drospirenone, Ethinyl Estradiol and Levomefolate Calcium Tablets 3mg/0.03mg/0.451 mg and Levomefolate Calcium Tablets 0.451 mg) to the consumer level due to out of specification test results at the 12-month stability time point.

Tydemy is estrogen/progestin oral contraceptive indicated for use by women to prevent pregnancy. To date, Lupin has received no reports of adverse events related to either recalled batches. Regardless, Lupin is recalling these two batches because if there were a significant reduction in the amount of inactive content, this could potentially impact the effectiveness of the product which could potentially result in unexpected pregnancy.

The lots were distributed nationwide in the U.S. to wholesalers, drug chains, mail order pharmacies and supermarkets. The recalled lots are included in the table below:

Lupin is notifying its wholesalers, distributors, drug chains, mail order pharmacies and supermarkets by phone and through recall notification and is arranging for the return of all the recalled product lots. Patients taking Tydemy are advised to continue taking their medication and immediately contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment.

Wholesalers, distributors and retailers that have the recalled lots of  Tydemy should discontinue distribution of the recalled product lots immediately. Consumers, wholesalers, distributors, and retailers with questions regarding this recall should contact Inmar Rx Solutions, Inc. at (866) 480-8206 Monday – Friday 09:00 am to 05:00 pm EST. For reimbursement, please have the recalled lots returned to Inmar Rx Solutions, Inc.;

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online
• Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

July 19, 2023

Cipla Issues Voluntary Nationwide Recall of Six Batches of Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 Metered Inhalation) Due to Container Defect

FOR IMMEDIATE RELEASE - Mumbai, India, July 6, 2023, New Jersey, U.S.A. July 6, 2023 – Cipla announced that its wholly-owned subsidiary Cipla U.S. is voluntarily recalling six batches of Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 Metered Inhalation) manufactured in November 2021 to the consumer level.

Risk Statement: There is a reasonable probability that failure to deliver the recommended dose to treat the respiratory symptoms of an acute asthma exacerbation such as wheezing, coughing, shortness of breath and bronchospasms, due to device defect, may be life-threatening. There were no adverse events reported for Albuterol Sulfate Inhalation Aerosol 90 mcg related to this recall. The company is initiating a recall in the U.S. due to a market complaint for one single inhaler, where leakage was observed through the inhaler valve. Out of an abundance of precaution, the above mentioned six batches manufactured using the same lot of valves are being recalled.

Consumers with questions, adverse reactions or quality problems regarding these six batches can contact Cipla customer service at 844- CIPLAUS (844-247-5287) Monday through Friday, 8:30 a.m. - 5:00 p.m. EST, or email cipla.cs@cipla.com. Consumers should contact their physician or health care provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report online: www.fda.gov/medwatch/report.htm
• Regular mail or fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

June 13, 2023

The Harvard Drug Group, LLC Issues Voluntary Nationwide Recall of Dronabinol Capsules, USP, 2.5 mg and Ziprasidone Hydrochloride Capsules, 20 mg Due to Label Mix-up

The Harvard Drug Group, LLC d/b/a Major Pharmaceutical and Rugby Laboratories is initiating a voluntary recall of a single lot of Dronabinol Capsules, USP, 2.5 mg and Ziprasidone Hydrochloride Capsules, 20 mg to the consumer level. The Harvard Drug Group, LLC received a customer complaint from a distributor, that some unit dose cartons labeled as Ziprasidone Hydrochloride Capsules, 20 mg were found to contain blister packages labeled as and containing Dronabinol Capsules, USP, 2.5 mg. Accordingly, The Harvard Drug Group, LLC is recalling all Dronabinol Capsules, USP, 2.5 mg, which may be in outer cartons that read Dronabinol Capsules, USP, 2.5 mg OR Ziprasidone Hydrochloride Capsules, 20 mg.

Risk Statement: There is a reasonable probability that patients who mistakenly take Dronabinol Capsules, USP, 2.5 mg instead of Ziprasidone Hydrochloride, 20 mg capsules, can experience serious adverse events from 1) missing their ziprasidone dose and 2) taking an unexpected dose of Dronabinol. Patients missing doses of Ziprasidone can experience exacerbation of underlying health issues such as bipolar disorder, schizophrenia, agitation, aggression, or delirium. This can result in mental illness instability with possible consequences of self-harm or harm to others which could result in medical or psychiatric hospitalization. Taking an unexpected dose of Dronabinol may cause mental and cognitive effects that result in impairment of mental and/or physical abilities. This can include worsening of symptoms in patients with mental illness disorders and limitation of patients’ abilities to safely complete hazardous activities. Elderly patients or those taking other medications that affect mental function may be particularly at risk for these reactions.  The Harvard Drug Group, LLC has not received any reports of adverse events related to this recall.

Products were distributed Nationwide to Wholesalers starting April 5, 2023.  Dronabinol Capsules, USP, 2.5 mg are white capsules imprinted with “M2” and Ziprasidone Hydrochloride Capsules, 20 mg are capsules with a lavender opaque cap and flesh opaque body, imprinted “RDY’ on the cap and “356” on the body.  The items are listed below:

The Harvard Drug Group, LLC is notifying all impacted direct accounts via mail of this voluntary recall and is arranging for return of all recalled products listed above.  Wholesalers, Distributors and Retailers that have the affected product which is being recalled should stop distribution of the product and consumers should stop using this affected product, return it to the place of purchase, and contact their physician or healthcare provider.

Consumers with questions regarding this recall can contact Sedgwick, Inc. by phone at 1-888-759-6904 (8:00am-5:00pm EST Monday through Friday) or by email address  harvarddrug6068@sedgwick.com.  Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event   Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online
• Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

May 9, 2023

Teva Initiates Voluntary Nationwide Recall of Specific Lots of FENTANYL Buccal Tablets CII Due to a Labeling Error

April 27, 2023, Parsippany, NJ  -   Teva Pharmaceuticals USA has initiated a voluntary nationwide recall of specific lots of various strengths of FENTANYL Buccal Tablets CII to the Consumer Level. Teva USA manufactured and labeled these product lots exclusively for Mayne Pharma, Inc. under Mayne’s label. This recall has been initiated because safety updates were omitted in the Product Insert/Medication Guide (MG) that is provided with these recalled lots.

The main safety concern is a potential for incomplete information needed by health care providers and patients regarding safe use of the product. Not following, or not being aware of, the omitted safety updates in the Product Insert/Medication Guide (MG) could lead to life-threatening adverse events; although, based on a Health Hazard Assessment conducted by Teva, the likelihood of the harm occurrence is considered remote. To date, Teva has not received any complaints related to the product labeling.

Consumers with questions or concerns should first consult with their health care provider(s). To report an Adverse Event or Quality Complaint, or if you have Medical-related Questions, please use the following contact information:

Medical-related Questions or to report an Adverse Event:
Contact Medical Information at: 888-483-8279 or USMedInfo@tevapharm.com
Live calls received: Monday through Friday from 9:00 a.m. - 5:00 p.m. ET - voicemail 24 hours a day, 7 days a week

Product Quality Complaint-related Questions:
Contact Quality Assurance Services: 1-888-838-2872, option 4
Live calls received: Monday through  Friday from 9:00 a.m. - 5:00 p.m. ET - voicemail: 24 hrs./day, 7 days/week 

Adverse events or other problems experienced with the use of this product may also be reported to the Food and Drug Administration's (FDA's) MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall was made with the knowledge of the FDA. Teva will continue to partner with, and regularly update, all relevant stakeholders, including regulatory authorities, to resolve this situation.

March 29, 2023

Ascend Laboratories, LLC Issues Voluntary Nationwide Recall of Dabigatran Etexilate Capsules, USP 75 mg and 150 mg, Due to the Detection of N-Nitroso-dabigatran (NDAB) Impurity

3/22/2023 - Ascend Laboratories, LLC is voluntarily recalling Dabigatran Etexilate Capsules USP 75mg  and 150mg to the consumer level due to the presence of a nitrosamine, N-nitroso-dabigatran, above the established Acceptable Daily Intake (ADI) level. To date, Ascend Laboratories,  LLC, has not received any reports of adverse events related to this recall. Nitrosamines are common in water and foods, including cured and grilled meats, dairy products and vegetables. Everyone is exposed to some level of nitrosamines. These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time. The product is used as an oral anticoagulant to lower the risk of stroke and blood clots. The Food and Drug Administration's National Drug Code Directory (NDC), lot number and expiration dates are listed in the table below:

Patients who have received impacted lots of Dabigatran Etexilate Capsules, USP 75 mg and 150 mg are advised to continue taking their medication and contact their physician for advice regarding an alternative treatment.

Customers with medical related questions, who wish to report an adverse event or quality issues about the products being recalled should contact Ascend Laboratories, LLC by phone at 1-877- 272-7901, 24 hours a day, 7 days a week.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report online at   www.fda.gov/medwatch/report.htm.
• Regular mail or fax: Download form at   www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form. Complete and return  to the address on the  form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

March 8, 2023

Apotex Corp. Issues Voluntary Nationwide Recall of Brimonidine Tartrate Ophthalmic Solution, 0.15% Due to Cracks that Have Developed in Some of the Units Caps of the Bottles

March 1, 2023 – Weston, Florida, Apotex Corp., with the knowledge of the US FDA, is initiating a voluntary recall at the consumer level for six lots of Brimonidine Tartrate Ophthalmic Solution 0.15% specified below. This recall is being initiated out of an abundance of caution due to cracks that have developed in some of the units caps of Brimonidine tartrate ophthalmic solution bottles. There is a possibility the broken cap may impact sterility and if so, the possibility of adverse events. These lots were distributed nationwide in the USA between April 5, 2022 and February 22, 2023.

Brimonidine Tartrate Ophthalmic Solution is an alpha-adrenergic receptor agonist indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

Apotex Corp. is notifying all impacted direct accounts of this voluntary recall via email and mail for return of product. Patients who have received the identified lots or have questions regarding this recall should contact their pharmacy or their health care provider for medical advice. Consumers with the impacted units of Brimonidine Tartrate Ophthalmic Solution, 0.15%, can contact Inmar Rx Solutions at 1-855-275-1273, to receive a recall/return packet including the Recall Stock Response Form. Consumers with questions regarding this recall can contact Apotex Corp. by phone at 1-800-706-5575 Monday through Friday from 8:30 a.m. – 5:00 p.m., EST  or by email  at   UScustomerservice@Apotex.com.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online: www.fda.gov/medwatch/report.htm
• Regular mail or fax: Download form at   www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the  form, or submit by fax to 1-800-FDA-0178.

February 28, 2023

Global Pharma Healthcare Issues Voluntary Nationwide Recall of Delsam Pharma Artificial Eye Ointment Due to Possible Microbial Contamination

February 23, 2023-Global Pharma Healthcare is voluntarily recalling Batch No. H29 of Artificial Eye Ointment, distributed by Delsam Pharma to the consumer level, due to possible microbial contamination. Additionally, some product packaging is leaking or may otherwise be compromised. Risk Statement - Use of contaminated eye ointment may cause adverse events, including infection in the eye that could lead to blindness. To date, Global Pharma Healthcare has not received any reports of adverse events related to this product.

Artificial Eye Ointment is used as an eye lubricant and to relieve dryness of the eyes. The affected product is packaged in a white aluminum tube within a paper carton. The product was distributed nationwide in the United States, and by Delsam Pharma through internet retail sites. Delsam Pharma’s NDC for this product is 72570-122-35, and its UPC code is 3 72570 012235 3.

Global Pharma Healthcare is notifying the brand owner and importer of this product, Delsam Pharma, about this recall, and is requesting that wholesalers, retailers and customers who have the recalled product should stop any use and discard the product safely and appropriately.

Consumers with questions regarding this recall can contact the distributor, Delsam Pharma, LLC, by phone at 1-866-826-1306 or by email at delsampharma@yahoo.com from Monday to Friday from 11 a.m. to 4 p.m. EST. Consumers should contact their physician or health care provider if they have experienced any problems that may be related to using these over-the-counter drug products.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting Program online at www.fda.gov/medwatch/report.htm or by regular mail or fax: Download form at   www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

February 8, 2023

Global Pharma Healthcare Issues Voluntary Nationwide Recall of Artificial Tears Lubricant Eye Drops Due to Possible Contamination

Global Pharma Healthcare is voluntarily recalling all lots within expiry of their Artificial Tears Lubricant Eye Drops, distributed by EzriCare LLC- and Delsam Pharma, to the consumer level, due to possible contamination. The Centers for Disease Control and Prevention (CDC) alerted FDA to an investigation of a multi-state cluster of Verona Integron-mediated Metallo-β-lactamase (VIM) and Guiana-Extended Spectrum-β-Lactamase (GES) producing carbapenem-resistant Pseudomonas aeruginosa (VIM-GES-CRPA) infections possibly associated with the use of the artificial tears manufactured by Global Pharma Healthcare. To date, there are 55 reports of adverse events including eye infections, permanent loss of vision and a death with a bloodstream infection. Use of contaminated artificial tears can result in the risk of eye infections that could result in blindness.

Artificial Tears (carboxymethylcellulose sodium) Lubricant Eye Drops, 10 mg in 1 mL, 0.5 fl oz (15 ml) bottle are used as a protectant against further irritation or to relieve dryness of the eye for the temporary relief of discomfort due to minor irritations of the eye, or to exposure to wind or sun. The product is packaged in a bottle with a safety seal and is placed in a carton box:

• Ezricare: NDC 79503-0101-15, UPC 3 79503 10115 7
• Delsam Pharma: NDC 72570-121-15, UPC -72570-0121-15

Global Pharma Healthcare is notifying the distributors of this product, Aru Pharma Inc and Delsam Pharma and is requesting that wholesalers, retailers and customers who have the recalled product should stop use. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by mail or fax.

Consumers with questions regarding this recall can contact the distributors: Aru Pharma/Ezricare LLC  by phone: 1-518-738-7602 from Monday to Friday, 11 a.m. to 4 p.m. EST, or email: arupharmainc@yahoo.com; or Delsam Pharma LLC by phone: 1-866-826-1309 from Monday to Friday, 11 a.m. to 4 p.m. EST, or email: delsampharma@yahoo.com . Consumers should contact their physician or health care provider if they have experienced any problems that may be related to using these over-the-counter drug products.

Complete and submit the report online or by mail or fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

February 8, 2023

IBSA Pharma Inc Issues Voluntary Nationwide Recall of Select Lots of TIROSINT®-SOL (levothyroxine sodium) Oral Solution Due to   Sub potency

IBSA Pharma Inc is voluntarily recalling 27 lots of TIROSINT®-SOL (levothyroxine sodium) Oral Solution to the consumer level. This voluntary recall has been initiated because these lots may be sub potent. The company’s analyses show a slight decrease below 95.0% of its labeled amount in levothyroxine sodium (T4) for some lots. This recall does not apply to TIROSINT® (levothyroxine sodium) capsules.

Risk statement: Patients being treated for hypothyroidism (underactive thyroid), who receive sub potent TIROSINT®-SOL, may experience signs and symptoms of hypothyroidism (underactive thyroid) which may include fatigue, increased sensitivity to cold, constipation, dry skin, puffy face, hair loss, slow heart rate, depression, swelling of the thyroid gland and/or unexplained weight gain or difficulty losing weight. Over- or under-treatment with TIROSINT® SOL may have negative effects on growth and development, cardiovascular function, bone metabolism, reproductive function, cognitive function, emotional state, gastrointestinal function and glucose and lipid metabolism. Any patients including those who might be pregnant, newborn infants, or elderly patients should contact their physician or health care provider if they have experienced any problems that may be related to taking or using this drug product. To date, IBSA Pharma Inc has not received any reports of adverse events that have been determined to be related to this voluntary recall.

TIROSINT®-SOL is indicated for:

• Hypothyroidism - As replacement therapy in primary (thyroidal), secondary (pituitary) and tertiary (hypothalamic) congenital or acquired hypothyroidism.
• Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression - As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well differentiated thyroid cancer.

IBSA Pharma Inc is proactively notifying its wholesalers, retailers and health care providers to discontinue distribution of the product being recalled and is arranging for the return of all recalled products. Patients who are currently taking TIROSINT®-SOL should not discontinue use without contacting their health care provider for further guidance and/or replacement prescription.

The product description, NDC numbers, lot numbers and expiration dates of affected TIROSINT® SOL lots are shown in the table below:

Consumers and health care providers with questions regarding this recall can contact IBSA Pharma Inc by phone number at 1-800-587-3513 Monday through Friday from 9 a.m. to 7 p.m. (EST), or by email at medinfo@ibsapharma.com. Consumers should contact their physician or health care provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by mail or by fax. Complete and submit online: www.fda.gov/medwatch/report.htm or by regular mail or fax: Download form at   www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form or submit by fax to 1-800-FDA-0178. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

December 22, 2022

Lupin Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Four Lots of Quinapril Tablets Due to Potential Presence of N-Nitroso-Quinapril Impurity

December 21, 2022 - Lupin Pharmaceuticals Inc. is voluntarily recalling four lots of Quinapril tablets to the patient level due to the presence of a nitrosamine impurity, N-Nitroso-Quinapril, observed in recent testing above the Acceptable Daily Intake (ADI) level. To date, Lupin has received no reports of illness that appear to relate to this issue.

Nitrosamines are common in water and foods; including cured and grilled meats, dairy products and vegetables. Everyone is exposed to some level of nitrosamines. These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time.

Quinapril tablet USP is an angiotensin-converting enzyme (ACE) inhibitor indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. The recalled lots are included in the table below:

Patients taking Quinapril tablets USP, 20mg, and 40mg are advised to continue taking their medication and contact their medical provider for advice regarding an alternative treatment.

Consumers, wholesalers, distributors and retailers with questions regarding this recall should contact Inmar Rx Solutions, Inc. at 877-538-8445 Monday – Friday 9:00 a.m. to 5:00 p.m. EST. For reimbursement, please have the recalled lots returned to Inmar Rx Solutions, Inc. Adverse reactions or quality problems experienced with the use of this may be reported to the FDA's MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.

Complete and submit the report Online: www.fda.gov/medwatch/report.htm.

Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form; then complete and return to the address on the pre-addressed form or submit by fax to 1-800-FDA-0178.

October 27, 2022

Aurobindo Pharma USA, Inc. Initiates Voluntary Nationwide Recall of Two (2) Lots of Quinapril and Hydrochlorothiazide Tablets USP 20mg/12.5mg, Due to the Detection of N-Nitroso Quinapril Impurity

October 24, 2022 – East Windsor, New Jersey, Aurobindo Pharma USA, Inc. has initiated a voluntary recall of two lots (refer  to table below) of Quinapril and Hydrochlorothiazide Tablets USP 20mg/12.5mg, to the consumer level from the US market due to presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Quinapril above the proposed interim limit. Aurobindo Pharma USA, Inc. began shipping of the subject batches to customers nationwide May 2021.

Nitrosamines are common in water and foods, including cured and grilled meats, dairy products and vegetables. Everyone is exposed to some level of nitrosamines. These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time. To date, Aurobindo Pharma USA, Inc. has not received any reports of adverse events related to this recall.

Quinapril and Hydrochlorothiazide Tablets, USP are fixed-combination tablets that combine an angiotensin-converting enzyme (ACE) inhibitor, quinapril hydrochloride, and a thiazide diuretic, hydrochlorothiazide. This product is indicated for the treatment of hypertension, to lower blood pressure. Patients should contact their doctor or health care provider about whether to continue taking their medication, or whether to consider an alternative treatment prior to returning their medication.

Consumers with medical questions regarding this recall or to report an adverse event can contact Aurobindo Pharma USA, Inc. at: 1-866-850-2876 (Option 2), 24 hours per day, 7 days per week.

Consumers should also contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Any general questions regarding the return of this product, please contact Qualanex at 1-888-504-2014 Monday - Friday (CST). Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report Online: www.fda.gov/medwatch/report.htm.

Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

October 4, 2022

Golden State Medical Supply, Inc. Issues a Voluntary Nationwide Recall of Atenolol 25 mg Tablets and Clopidogrel 75 mg Tablets Due to a Label Mix-up

SEPTEMBER 29, 2022, Golden State Medical Supply, Incorporated (GSMS, Inc.) - Camarillo, CA has initiated a voluntary recall of the products listed in the table below because a report was received that a bottle containing Clopidogrel 75mg Tablets produced with lot number GS046745 was mislabeled as Atenolol 25mg Tablets. This voluntary recall only affects products with lot number GS046745. No other Clopidogrel or Atenolol products marketed by GSMS, Inc. are impacted. Both products are being recalled out of an abundance of caution.

Atenolol tablets are indicated for the treatment of hypertension, to lower blood pressure. Clopidogrel is prescribed to lower the risk of having a stroke, blood clot or serious heart problem for patients who have had heart attack, severe chest pain, or circulation problems as indicated in the product labeling.

Patients who suddenly stop taking atenolol, as would happen if clopidogrel were misplaced in the atenolol-labeled bottle, are at increased risk for ischemic (angina, myocardial infarction), hypertensive and arrhythmic adverse events relating to rapid withdrawal of beta antagonism. Further, patients who are on atenolol are frequently on concomitant anticoagulant and antiplatelet medications and would be at increased risk for bleeding if clopidogrel were added to the regimen. To date, GSMS, Inc. has not received any reports of adverse events related to the use of the products as part of this recall.

Consumers with questions regarding this recall can contact GSMS, Inc. by phone at (800) 284-8633, ext. 116  between 7:30  a.m. and 4:00 p.m. Pacific).

July 20, 2022

Vi-Jon, LLC Expands Voluntary Nationwide Recall of Magnesium Citrate Saline Laxative Oral Solution Lemon Flavor Due to Microbial Contamination

 July 14, 2022 – Smyrna, TN, Vi-Jon, LLC is expanding its voluntary recall to include all lots of Magnesium Citrate Saline Laxative Oral Solution Lemon Flavor, 10 FL OZ (296 mL) within expiry to the consumer level. The recall was initiated after 3rd Party and Vi-Jon, LLC microbial testing identified the presence of Gluconacetobacter liquefaciens.

Risk Statement: Immunocompromised patients, who consume this product, may be at increased risk for invasive infections caused by Gluconacetobacter liquefaciens that could lead to serious, life-threatening adverse health consequences. To date, Vi-Jon, LLC has received one report of an adverse reaction potentially related to this recall. Vi-Jon, LLC is in the process of investigating this report.

The product is used for relief of occasional constipation (irregularity) and generally produces bowel movement in ½ to 6 hours. The product is packaged in a 10 oz. clear round plastic bottle.

The affected brands of Magnesium Citrate Laxative Oral Solution Lemon Flavor manufactured at Vi-Jon, LLC in Smyrna, TN are:

The product was distributed Nationwide to wholesale and retail outlets. Vi-Jon, LLC is continuing their investigation into the cause of the problem.

Vi-Jon, LLC is notifying its customers by phone and email and is arranging for return or destruction of all recalled product. Consumers that have this recalled product should stop using and return any remaining product to the place of purchase.

Consumers with questions regarding this recall can contact Vi-Jon, LLC by e-mail (Recalls@Vijon.com) Monday-Friday, from 7:30 a.m. to 4:30 p.m., Central Time. Consumers should contact their physician or health care provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online
• Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

July 11, 2022

Mylan Pharmaceuticals Inc., a Viatris Company, Issues Voluntary Nationwide Recall of One Batch of Insulin Glargine (Insulin glargine-yfgn) Injection Pens, 100 units/mL (U-100), Due to the Potential of Missing Labels on Some Pens

 July 5, 2022 – Mylan Pharmaceuticals Inc., a Viatris company, is voluntarily recalling one batch of Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100), 3 mL prefilled pens which are packaged in cartons of five pens to the consumer level. This product is not the branded Semglee® pen but the unbranded Insulin Glargine-yfgn pen. This batch is being recalled due to the potential for the label to be missing on some pens.

This recall pertains only to the unbranded interchangeable biosimilar Insulin Glargine-yfgn pens and does not impact the branded interchangeable biosimilar Semglee® (insulin glargine-yfgn) injection pens.

This product is a long-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. The product is packaged in a 3 mL prefilled pen which is then packaged in cartons of five pens. The product information, batch number and expiry date information are present on the carton. A missing label on Insulin Glargine pens could lead to a mix-up of products/strengths, which may result in less optimal glycemic control (either high or low blood sugar) which could result in serious complications. To date, no adverse events related to this recall have been received for this product.

If you have an unlabeled pen, please contact Sedgwick at 1-877-643-8438 for the documentation packet to return the product.

Consumers with questions regarding this recall can contact Viatris Customer Relations by phone at 1-800-796-9526 or by email at customer.service@viatris.com, Monday through Friday from 8 a.m. – 5 p.m. EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Additional information may be found on the FDA recall website at: Mylan Pharmaceuticals Inc., a Viatris Company, Issues Voluntary Nationwide Recall of One Batch of Insulin Glargine (Insulin glargine-yfgn) Injection Pens, 100 units/mL (U-100), Due to the Potential of Missing Labels on Some Pens.

June 28, 2022

Bryant Ranch Prepack Inc. Issues Voluntary Nationwide Recall of Morphine Sulfate 30 mg Extended Release and Morphine Sulfate 60 mg Extended-Release Due to Label-Mix Up

 Bryant Ranch Prepack Inc. is voluntarily recalling one lot of Morphine Sulfate 30 mg Extended-Release tablets, and one lot of Morphine Sulfate 60 mg Extended-Release tablets to the consumer level listed in the table below. The products have been found to have incorrect labeling where bottles labeled as Morphine Sulfate 60 mg Extended-Release tablets contain Morphine Sulfate 30 mg Extended-Release tablets and bottles labeled as Morphine Sulfate 30 mg Extended-Release tablets may contain Morphine Sulfate 60 mg Extended-Release tablets.

Risk Statement: Patients prescribed the 30 mg dose who receive the 60 mg dose could be at risk for overdose and death. Patients prescribed the 60 mg dose who receive the 30 mg dose may experience withdrawal and untreated pain if the dose given is too low. To date, Bryant Ranch Prepack Inc. has not received any reports of adverse events related to this recall.

Bryant Ranch Prepack is notifying its distributors and customers by email, phone, and letter, and is arranging for return of all recalled products. Consumers/distributors/retailers that have these products which are being recalled should stop using and contact Bryant Ranch Prepack Inc. at: cs@brppharma.com

Consumers with questions regarding this recall can contact Bryant Ranch Prepack Inc. by 877-885-0882 or cs@brppharma.com, Monday-Friday 7:30am-5:00pm PDT. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program.  Affected Consumers may  call 

May 26, 2022

Teva Issues Voluntary Nationwide Recall of One Lot of Anagrelide Capsules, USP 0.5 mg Due to Dissolution Test Failure

Teva Pharmaceuticals USA has initiated a voluntary nationwide recall of a single lot of Anagrelide Capsules, USP 0.5 mg to the consumer level in the United States. This voluntary recall was initiated due to dissolution test failure detected during routine stability testing. No other lots are impacted.

Administration of this product with lower dissolution, taking longer to dissolve once ingested, may result in decreased effectiveness or ineffectiveness of the drug to exert its platelet-reducing effect. For seriously ill patients with elevated platelet counts, less available anagrelide in the body could increase the risk of clotting (blood coagulation), and clotting or bleeding events such as a heart attack or stroke, which could be life threatening. To date, Teva has not received any product quality complaints or adverse event reports of this nature for the recalled lot.

Teva notified its customers on May 11, 2022, alerting them that the lot was recalled and requesting that they return impacted product. Consumers with questions or concerns should first consult with their health care provider(s). Patients with the affected product should call 1-888-838-2872 for instructions on how to return their product and obtain reimbursement for their cost.

April 29, 2022

FDA Alerts Customers to Voluntary Recall of Compounded Drugs Due to Sterility Issues by Drug Depot, LLC, dba APS Pharmacy

April 26, 2022.   FDA is alerting patients, health care professionals, veterinarians, and animal owners/caretakers about a voluntary recall by Drug Depot, LLC, doing business as APS Pharmacy, of certain unexpired compounded drugs due to a lack of sterility assurance. Administration of a non-sterile drug intended to be sterile may result in serious and potentially life-threatening infections.

APS Pharmacy, located in Palm Harbor, Florida, which compounds drugs intended for human use and drugs intended for animal (veterinary) use, initiated the voluntary nationwide recall via a recall letter dated March 15, 2022. The company has sent recall letters to all patients and animal owners who received the recalled drugs, and they are contacting all customers via telephone calls and emails as part of their recall strategy.

The recalled drugs include gonadorelin acetate, testosterone cypionate in grapeseed oil, testosterone cypionate/anastrozole in grapeseed oil, testosterone cypionate/DHEA in grapeseed oil, and testosterone cypionate/propionate in sesame seed oil  for human use, and cyclosporin    and tacrolimus    for animal ophthalmic use. These products were compounded between December 21, 2021, and March 7, 2022. The recalled drugs, lot numbers, and do-not-use beyond date - the date when the compounded drug should no longer be used - are listed here.

Since the company initiated the recall and began contacting patients using the recalled drugs, FDA has received adverse event reports from APS Pharmacy regarding injection site reactions, such as pain, redness, swelling and abscesses requiring medical treatment; and systemic reactions, which include fever, chills, and rash. To date, FDA has received two reports of adverse events occurring in animals following use of the recalled animal ophthalmic products.

Patients should not use, and animal owners/caretakers should not administer, the recalled drugs from APS Pharmacy. If they are not sure if they have a recalled drug, they should contact APS pharmacy to confirm. Patients who have received these recalled drugs from APS Pharmacy should contact their health care professional. Animal owners/caretakers should contact their veterinarian as appropriate.

Health care professionals and veterinarians should immediately check their medical supplies, quarantine any recalled drugs from APS Pharmacy, and not administer or provide them to patients or animals.

FDA urges health care professionals and consumers who obtained recalled drugs from this company to make alternative arrangements to obtain medications from sources that meet applicable quality standards.

Health care professionals and consumers should report adverse events or side effects related to the use of products from APS Pharmacy to FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online at www.fda.gov/medwatch/report.htm; or
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

Veterinarians and animal owners/caretakers should report adverse events or side effects in animals related to the use of these products to FDA’s Center for Veterinary Medicine. Please visit How to Report Animal Drug and Device Side Effects and Product Problems for more information.

April 27, 2022

Pfizer Voluntary Nationwide Recall of Lots of ACCUPRIL® (Quinapril HCl) Due to N-Nitroso-Quinapril Content

April 22,2022. Pfizer is voluntarily recalling five lots of Accupril (Quinapril HCl) tablets distributed by Pfizer to the patient level due to the presence of a nitrosamine, Nnitroso-quinapril, observed in recent testing above the Acceptable Daily Intake (ADI) level. Nitrosamines are common in water and foods, including cured and grilled meats, dairy products and vegetables. Although long-term ingestion of Nnitroso-quinapril may be associated with a potential increased cancer risk in humans, there is no immediate risk to patients taking this medication.

To date, Pfizer is not aware of reports of adverse events that have been assessed to be related to this recall. Patients currently taking the products should consult with their doctor or health care provider about alternative treatment options for them.

Patients who are taking this product should consult with their healthcare provider or pharmacy to determine if they have the affected product. Patients with the affected product should contact Sedgwick at 1-888-345-0481 (Monday -Friday 8:00 a.m. - 5:00 p.m. ET) for instructions on how to return their product and obtain reimbursement for their cost.

Additional information may be found on the FDA recall website at: FDA Voluntary Pfizer Nationwide Recall of Lots of Accupril (Quinapril HCL) Due to N-Nitroso-Quinapril Content.

April 21, 2022

Mylan Pharmaceuticals Inc., Nationwide Recall of One Batch of Insulin Glargine Injection, 100 units/mL (U-100) Due to the Potential for a Missing Label in the Batch

April 12, 2022. Mylan Pharmaceuticals Inc., a Viatris company, is voluntarily recalling one batch of its Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100), which is packaged in a 10 mL vial that is inside a carton. This batch is being recalled due to the potential for the label to be missing on some vials. The product information, batch number and expiry date information are present on the carton. The recalled batch is as follows:

This recall does not pertain to the branded interchangeable biosimilar, Semglee® (insulin glargine) injection but to the unbranded interchangeable biosimilar Insulin Glargine-vial.

The product is a long-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.  For patients receiving treatment with more than one type of insulin (e.g., both short and long-acting insulin), a missing label on Insulin Glargine vials could lead to a mix-up of products/strengths, which may result in less optimal glycemic control (either high or low blood sugar) which could result in serious complications. To date, no adverse events related to this recall have been received for this product.

If you have an unlabeled product, please contact Stericycle at 1-888-912-7084 for the documentation packet to return product to Stericycle.

Consumers with questions regarding this recall can contact Viatris Customer Relations by 1-800-796-9526 or customer.service@viatris.com, Monday through Friday from 8 a.m. – 5 p.m. EST. Consumers should contact their physician or health care provider if they have experienced any problems that may be related to taking or using this drug product.

Additional information may be found on the FDA recall website at: Mylan Pharmaceuticals Inc., a Viatris Company, Conducting Voluntary Nationwide Recall of One Batch of Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100), Due to the Potential for a Missing Label in the Batch | FDA.

March 23, 2022

Adamis Pharmaceuticals Corporation Issues Nationwide Voluntary Recall of SYMJEPI® (Epinephrine) Injection for Potential Manufacturing Defect

March 21, 2022 - Adamis Pharmaceuticals Corporation is voluntarily recalling certain lots of SYMJEPI (epinephrine) Injection 0.15 mg (0.15 mg/0.3 mL) and 0.3 mg (0.3 mg/0.3 mL) Pre-Filled Single-Dose Syringes to the consumer level. The batches in the table below are being recalled due to the potential clogging of the needle preventing the dispensing of epinephrine.

If a person is experiencing an allergic reaction and/or anaphylaxis and is unable to access life-saving epinephrine due to the syringe malfunction, it can lead to life threatening consequences including death. Although not confirmed to be related to the recall, there have been two different customer complaints on three syringes, regarding difficulty in dispensing the product, to date.

Consumers and institutions that have products that are subject to this recall should stop using the products immediately and may either return or discard the recalled lots. Consumers with questions regarding this recall can call (888)900-8796 or e-mail questions at medinfo@usworldmeds.com Monday-Friday from 8:00 a.m. to 4:00 p.m. ET.

Additional information may be found on the FDA recall website at: Adamis Pharmaceuticals Corporation Issues Nationwide Voluntary Recall of SYMJEPI® (Epinephrine) Injection for Potential Manufacturing Defect.

March 23, 2022
Pfizer Issues Voluntary Recall of Lots of Accuretic®, Quinapril and Hydrochlorothiazide Tablets, and Quinapril/Hydrochlorothiazide Tablets Due to nitrosamine, N-nitroso-quinapril Content

March 21,2022 - Pfizer is voluntarily recalling Accuretic (quinapril HCl/hydrochlorothiazide) tablets distributed by Pfizer as well as two authorized generics distributed by Greenstone (quinapril and hydrochlorothiazide and quinapril HCl/ hydrochlorothiazide) to the patient (consumer/user) level due to the presence of a nitrosamine, N-nitroso-quinapril, above the Acceptable Daily Intake (ADI) level.

Although long term ingestion of N-nitroso-quinapril may be associated with a potential increased cancer risk in humans, there is no immediate risk to patients taking this medication. Patients currently taking the products should consult with their doctor about alternative treatment options.

Accuretic® (quinapril HCl/hydrochlorothiazide) tablets, 10/12.5 mg
Accuretic® (quinapril HCl/hydrochlorothiazide) tablets, 20/12.5 mg
Accuretic® (quinapril HCl/hydrochlorothiazide) tablets, 20/25 mg

quinapril and hydrochlorothiazide tablets, 20/25 mg
quinapril HCl/hydrochlorothiazide tablets, 20/12.5 mg
quinapril HCl/hydrochlorothiazide tablets, 20/25 mg

Patients who are taking this product should consult with their healthcare provider or pharmacy to determine if they have the affected product. Patients with the affected product should contact Sedgwick at 888-843-0247 (Mon.-Fri. 8:00 a.m. - 5:00 p.m. ET) for instructions on how to return their product and obtain reimbursement for their cost.

Additional information may be found on the FDA recall website at: Pfizer Voluntary Nationwide Recall of Lots of Accuretic® (Quinapril HCl/Hydrochlorothiazide), Quinapril and Hydrochlorothiazide Tablets, and Quinapril HCl/Hydrochlorothiazide Tablets Due to N-Nitroso-Quinapril Content.

March 23, 2022

Sandoz, Inc. Issues Nationwide Recall of Orphenadrine Citrate 100 mg Extended Release Tablets Due to Presence of a Nitrosamine Impurity

March 21, 2022 - Sandoz Inc. is initiating a voluntary recall of 13 lots (listed below) of oral Orphenadrine Citrate 100 mg Extended Release (ER) Tablets to the consumer level. The presence of a nitrosamine impurity, which has the potential to be above the U.S. Food and Drug Administration (FDA) Acceptable Daily Intake (ADI) limit of 26.5 ng/day, was detected in the lots during recent testing. These 13 lots of Orphenadrine Citrate ER Tablets were shipped to customers from August 2019 to April 2021.

Nitrosamines are substances with carcinogenic potency (substances that could cause cancer) when present above the allowable exposure limits. While the use of product belonging to the recalled lots may represent a risk to patients, to date, Sandoz has not received any reports of adverse events related to the presence of a nitrosamine impurity in the lot.

This recall of Orphenadrine Citrate ER Tablets is specific to the lots listed above and does not apply to any other strengths of Sandoz Orphenadrine Citrate ER Tablets nor to other lot numbers of the product. Any product returned that is not associated with this recall will be destroyed, and no credit will be issued.

Consumers who have Orphenadrine Citrate ER Tablets being recalled should stop taking the recalled product and immediately consult with their physician to obtain another prescription. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Additional information may be found on the FDA recall website at: Sandoz, Inc. Issues Nationwide Recall of 13 Lots of Orphenadrine Citrate 100 mg Extended Release Tablets Due to Presence of a Nitrosamine Impurity.

January 30, 2022

AuroMedics Pharma, LLC Issues Voluntary Recall of Polymyxin B for Injection Due to the Presence of Particulate Matter

January 26, 2022 - AuroMedics Pharma, LLC has initiated a voluntary recall of NDC 55150-0234-10, lot number CPB200013 of Polymyxin B for Injection USP, 500,000 Units/Vial to the consumer level due to the presence of particulate matter (identified as hair) being discovered in a vial within this lot.

The administration of an intravenous product containing hair, even with the use of a filter, could cause a patient to experience serious hypersensitivity reactions that may be life-threatening. To date, AuroMedics Pharma, LLC has not received reports of any adverse events or identifiable safety concerns attributed to the product consumed from this lot.

Consumers that have the product lot which is being recalled should immediately stop using and return to place of purchase/contact their doctor as appropriate. If you have any general questions regarding the return of this product, please contact Qualanex at 1-888-280-2046 or email recall@qualanex.com (live calls received 7:00 a.m. to 4:00 p.m. Mon. thru Fri. CST).

Additional information may be found on the FDA recall website at: AuroMedics Pharma LLC Issues Voluntary Recall of Polymyxin B for Injection Due to the Presence of Particulate Matter.

January 19, 2022

Mylan Pharmaceuticals, Inc. Issues Voluntary Recall of One Batch of Semglee® (insulin glargine injection), 100 units/mL (U-100), 3 mL Prefilled Pens, Due to the Potential for a Missing Label in the Batch

January 18, 2022 – Mylan Pharmaceuticals, Inc., a Viatris company, is voluntarily recalling one batch of its non-interchangeable Semglee® (insulin glargine injection), 100 units/ml (U-100), 3 mL prefilled pens, which are packaged in a labelled carton of five (5) pens. The product is being recalled due to the potential for the label to be missing on some prefilled pens within a labelled carton for this particular batch. The recalled product can be identified by prefilled pens missing a white label with the product name and dosage information affixed around the pen.

The recalled lot is as follows:

A missing label on Semglee® (insulin glargine) prefilled pens, for patients receiving treatment with more than one type of insulin (e.g., both short- and long-acting insulin), could lead to a mix-up of products/strengths, resulting in administration of the wrong insulin. Administration of the wrong insulin could result in less optimal glycemic control (either high or low blood sugar) which could result in serious complications. To date, the company has not received any reports of adverse events related to this recall.

This recall does not pertain to the recently launched interchangeable biosimilars, Semglee® (insulin glargine-yfgn) injection, a branded product, or Insulin Glargine (insulin glargine-yfgn) injection, an unbranded product.

If you have an unlabeled product, please contact Stericycle at 1-888-843-0255 for the documentation packet to return product to Stericycle. Questions regarding this recall can be directed to Viatris Customer Relations at 800-796-9526 or customer.service@viatris.com, Monday through Friday from 8 a.m. – 5 p.m. EST.

Additional information may be found on the FDA recall website at: Mylan Pharmaceuticals Inc., a Viatris Company, Conducting Voluntary Recall of One Batch of Semglee® (insulin glargine injection), 100 units/mL (U-100), 3 mL Prefilled Pens, Due to the Potential for a Missing Label in the Batch.

December 30, 2021

Padagis Issues Voluntary Nationwide Recall for Nitroglycerin Lingual Spray Due to a Possible Defective Delivery System

December 27, 2021 – Padagis U.S., LLC has issued a voluntary nationwide recall to the consumer/user level of the lots of Nitroglycerin Lingual Spray listed in the table below. Out of an abundance of caution, this product is being recalled from the market due to a complaint received that a unit may not dispense. There is a remote risk that the product may not properly dispense medication to patients in the event of a malfunction of their dispensing unit. All packaging and branding on affected units is that of Perrigo Company PLC. This recall applies only to the 12 g spray bottle and not the 4.9 g spray bottle of this medication.

Healthcare providers, distributors, and retailers that have product which is being recalled should stop distribution. Patients who have this product should contact their healthcare provider for an alternate replacement before returning the recalled product. The necessary form to document product information, as well as other information, is available by contacting Sedgwick at padagis5665@sedgwick.com or 888-266-7912.Additional information may be found on the FDA recall website at: Padagis Issues Voluntary Nationwide Recall for Nitroglycerin Lingual Spray Due to a Possible Defective Delivery System.

December 30, 2021

Taro Pharmaceuticals U.S.A. Issues Voluntary Nationwide Recall of Clobetasol Propionate Ointment 0.05% Due to Microbial Contamination

December 27, 2021 ─ Taro Pharmaceuticals U.S.A., Inc. is voluntarily recalling one lot of Clobetasol Propionate Ointment USP, 0.05% to the consumer level due to the presence of Ralstonia pickettii bacteria (“R. pickettii”), which was discovered by the manufacturer through routine testing. This recall ONLY applies to tubes labeled with the affected Lot Number and Expiration Date displayed on the bottom of each tube and the end flap of the product carton. No other lots of this product are impacted.

R. pickettii is present in the natural environment (soil, water) and for healthy individuals with intact skin, is unlikely to cause any localized or systemic infections. However, for individuals who are immunocompromised, or whose skin is not intact (i.e. sunburn, psoriasis, abrasions), there is a reasonable possibility that systemic infections may occur if the product is contaminated with R. pickettii due to the presence of the corticosteroid component which enhances absorption of the ointment. To date, Taro has not received any adverse event reports related to this lot.

Consumers with questions regarding this recall can contact Taro by calling 1-866-923-4914 or by e-mail at TaroPVUS@taro.com, Monday through Friday between 7:00 a.m. and 7:00 p.m., U.S. Central Time. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Additional information may be found on the FDA recall website at: Taro Pharmaceuticals U.S.A. Issues Voluntary Nationwide Recall of Clobetasol Propionate Ointment 0.05%.

December 30, 2021

Viona Pharmaceuticals Inc., Issues Voluntary Nationwide Recall of Metformin HCl Extended-Release Tablets, USP 750 mg, Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity

12/28/2021 – Cranford, NJ, Viona Pharmaceuticals, Inc., is voluntarily recalling 33 lots of Metformin Hydrochloride Extended-Release Tablets, USP 750 mg to the retail level. Reason for the recall is that the product has been found to contain levels of Nitrosodimethylamine (NDMA) impurities above acceptable daily limits. As a precautionary measure the company has voluntarily recalled all the marketed 33 batches having valid shelf life. This product was manufactured by Cadila Healthcare Limited, Ahmedabad, India for U.S. distribution by Viona Pharmaceuticals, Inc.

NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products and vegetables.

Patients who have received impacted lots of Metformin Hydrochloride Extended-Release Tablets, USP 750 mg are advised to continue taking their medication and contact their physician for advice regarding an alternative treatment.

Additional information may be found on the FDA recall website at: Viona Pharmaceuticals Inc., Issues Voluntary Nationwide Recall of Metformin HCl Extended-Release Tablets, USP 750 mg, Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity.

December 9, 2021

Edge Pharma, LLC Issues Voluntary Nationwide Recall of All Drug Products Due to Lack of Sterility Assurance

December 4, 2021 – Edge Pharma, LLC is voluntarily recalling all lots of all drugs compounded at Edge Pharma, LLC to the consumer level. All products are being recalled due to process issues that could lead to a lack of sterility assurance for products intended to be sterile and could impact the safety and quality of non-sterile products.

Administration of a drug product intended to be sterile, that is not sterile, could result in site specific infections as well as serious systemic infections which may be life-threatening. To date, Edge Pharma, LLC has not received and is not aware of any adverse events related to this recall.

The names and concentration of the drugs as well as the affected lots and expiration dates can be found at https://edgepharma.com/assets/recalledproducts.pdf.

Edge Pharma, LLC is notifying its customers by email, Media and FDA alerts, and direct outreach. Consumers and institutions that have Edge Pharma, LLC products should stop using the products immediately and may either return or discard the recalled lots.

Consumers with questions regarding this recall can contact Edge Pharma, LLC by phone at 802-992-1178 or e-mail at recall@edgepharma.com Monday-Friday from 8:00 a.m. to 4:00 .pm., EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these drug products.

Additional information may be found on the FDA recall website at: Edge Pharma, LLC Issues Voluntary Nationwide Recall of All Drug Products Due to Lack of Sterility Assurance.

December 9, 2021

Sandoz, Inc. Issues Voluntary Nationwide Recall of One Lot of Enoxaparin Sodium Injection, USP 40mg/0.4 mL Due to Temperature Excursion During Shipping

December 01, 2021- Sandoz Inc. (“Sandoz”) is initiating a recall of one lot of Enoxaparin Sodium Injection, USP 40 mg/0.4 mL Single-Dose Syringes as a portion of the affected lot experienced a temperature excursion during shipment. This product was shipped to customers in the months of September and October 2021. This recall is specific to only one batch (SAB06761A, Exp 04/2023) of Enoxaparin Sodium Injection, USP 40 mg/0.4 mL and does not apply to any other strengths of Sandoz Enoxaparin Sodium Injection, USP or to other lots of the 40 mg/0.4 mL.

The exposure to higher temperatures may have impacted the recalled product’s effectiveness and there may be reasonable probability of risk for patients with health conditions that the product is intended to treat. Such patients could be at risk for blood clots blocking blood vessels, an artery, or traveling to other tissues or organs causing pain, swelling, stroke, clots to the lung or death as a result of the underlying condition. To date, Sandoz has not received any reports of adverse events or injuries related to this recall.

The product is used for prevention of deep vein thrombosis (DVT) a condition that occurs when a blood clot forms in a deep vein, usually in the legs that can occur after surgeries or in patients with restricted mobility during illness; or prevention of complications associated with heart attacks. The product is packaged in cartons containing ten 0.4 mL syringes, NDC 0781-3246-64. Enoxaparin Sodium Injection was distributed nationwide in the USA to wholesalers and retailers.

Consumers who have Enoxaparin Sodium Injection, USP 40 mg/0.4 mL (NDC 00781-3246-64 and Lot number SAB06761A) which is being recalled, should stop taking the recalled product, immediately consult with their physician to attain another prescription, and return the product where originally purchased. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Additional information may be found on the FDA recall website at: Sandoz, Inc. Issues Nationwide Recall of One Lot of Enoxaparin Sodium Injection.

December 9, 2021

Teligent Pharma, Inc. Expands Worldwide Voluntary Recall of Lidocaine HCl Topical Solution 4% Due to Super Potency

December 07, 2021- Teligent Pharma, Inc. is voluntarily recalling two additional lots of Lidocaine HCl Topical Solution 4%, 50ml (NDC 63739-0997-64) in a screw cap glass bottle. The product is being recalled because the firms testing has found it to be super potent based on an Out of Specification (OOS) result obtained at the 9-month (Lot 16345, expiration 01/2024) and 18-month (Lot 15594, expiration 05/2023) stability time point.

An increased lidocaine dose could lead to the development of local anesthetic systemic toxicity depending on the duration of the treatment and the specific patient. Local anesthetic systemic toxicity can result in central nervous system reactions including excitation and/or depression and more serious signs of cardiovascular toxicity, such as bradycardia, hypotension, and even cardiovascular collapse can present very quickly.

Consumers should contact their physician or health care provider if they have experienced any problems that may be related to taking or using this drug product. Consumers that have Lidocaine HCl Topical Solution 4% which is being recalled are asked to discontinue use and call 1-856-697-1441 and press * to reach the medical information call center Monday through Friday, 8a.m. – 5p.m. or send an e-mail to medical@teligent.com    for any product questions and to receive instructions on reimbursement and shipping.

Additional information may be found on the FDA recall website at: Teligent Pharma, Inc.’s Issues Worldwide Voluntary Recall of Lidocaine HCl Topical Solution 4% Due to Super Potency.

October 19, 2021
Bryant Ranch Prepack Issues Voluntary Nationwide Recall of Methocarbamol 500mg Bottles Due to Mislabeling With the Incorrect Strength

October 19, 2021- Bryant Ranch Prepack is voluntarily recalling 1 lot of Methocarbamol 500mg tablets to the consumer level. The bottles labeled as Methocarbamol 500mg tablets have been found to contain Methocarbamol 750mg tablets. If a patient takes a 750mg tablet of Methocarbamol instead of the prescribed 500mg tablets, it potentially could result in Excessive Central Nervous System depression which may result in nausea, sedation, fainting, falls, seizure, coma and death. Bryant Ranch Prepack has not received any reports of adverse events related to this recall.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Consumers with questions regarding this recall can contact Bryant Ranch Prepack by phone at 877-885-0882 Mon.-Fri. 7 a.m.-6 p.m. PST or compliance@brppharma.com.

Additional information may be found on the FDA recall website at: Bryant Ranch Prepack Issues Voluntary Nationwide Recall of Methocarbamol 500mg Bottles Due to Mislabeling With the Incorrect Strength.

October 15, 2021

Lupin Pharmaceuticals, Inc. Issues Voluntarily Nationwide Recall of All Irbesartan Tablets and Irbesartan and Hydrochlorothiazide Tablets Due to Potential Presence of N-nitrosoirbesartan Impurity

October 14, 2021- Lupin Pharmaceuticals Inc. is voluntarily recalling the below-mentioned batches of Irbesartan Tablets and Irbesartan and Hydrochlorothiazide Tablets to the consumer level. As part of Lupin’s ongoing assessment, analysis revealed that certain tested API batches (but not finished product batches) were above the specification limit for the impurity, N-nitrosoirbesartan. Although Lupin has received no reports of illness that appear to relate to this issue, the company, out of an abundance of caution, is recalling all batches of Irbesartan Tablets USP 75mg, 150mg and 300mg and Irbesartan and Hydrochlorothiazide Tablets USP, 150mg/12.5mg and 300mg/12.5mg in the US. N-nitrosoirbesartan impurity is a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests.

Consumers should contact their physician or health care provider if they have experienced any problems that may be related to taking or using this drug product. Consumers, wholesalers, distributors, and retailers with questions regarding this recall should contact Inmar Rx Solutions, Inc. at (855) 769-3988 / (855) 769-3989 Monday – Friday 09:00 a.m. to 05:00 p.m. EST.

Additional information may be found on the FDA recall website at: Lupin Pharmaceuticals, Inc. Issues Voluntarily Nationwide Recall of All Irbesartan Tablets and Irbesartan and Hydrochlorothiazide Tablets.

October 13, 2021

Teligent Pharma, Inc.’s Issues Worldwide Voluntary Recall of Lidocaine HCl Topical Solution 4% Due to Super Potency

October 12, 2021- Teligent Pharma, Inc. is voluntarily recalling the five lots of Lidocaine HCl Topical Solution 4%, 50ml in a screw cap glass bottle listed in the table below to the user level. The product is being recalled because the firms testing has found it to be super potent based on an Out of Specification (OOS) result obtained at the 18-month stability timepoint. An increased lidocaine dose could lead to the development of local anesthetic systemic toxicity depending on the duration of the treatment and the specific patient. Local anesthetic systemic toxicity can result in central nervous system reactions including excitation and/or depression and more serious signs of cardiovascular toxicity, such as bradycardia, hypotension, and even cardiovascular collapse can present very quickly.

Consumers should contact their physician or health care provider if they have experienced any problems that may be related to taking or using this drug product. Consumers with questions regarding this recall can contact Teligent Pharma, Inc. by phone at 1-856-697-1441. Press * to reach the medical information call center Monday through Friday, 8 a.m. – 5 p.m. or send an e-mail to Medical@teligent.com.

Additional information may be found on the FDA recall website at: Teligent Pharma, Inc.’s Issues Worldwide Voluntary Recall of Lidocaine HCl Topical Solution 4% Due to Super Potency.

September 28, 2021

Eli Lilly and Company Issues Voluntary Nationwide Recall of One Lot of GLUCAGON® Emergency Kit Due to Loss of Potency

September 26, 2021 - Eli Lilly and Company is voluntarily recalling lot D239382D, Expiration April 2022, of Glucagon Emergency Kit for Low Blood Sugar, to the consumer/user level. Lilly is recalling because of a product complaint reporting that the vial of Glucagon was in liquid form instead of the powder form. The firm’s investigation indicates that the liquid in this Glucagon vial could be related to the manufacturing process. The use of the liquid form of this product may fail to treat severe low blood sugar due to loss of potency. Severe hypoglycemia in patients with diabetes, if not reversed, can potentially cause adverse health consequences ranging from transient, minor complaints to neurological damage, seizures, and even death if not promptly treated.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Consumers in possession of Glucagon Emergency Kit lot D239382D should contact The Lilly Answers Center at 1-800-LILLYRX (1-800-545-5979) for return and replacement instructions for the product (hours of operation are Monday - Friday, 9 a.m. – 7 p.m. EST).

Additional information may be found on the FDA recall website at: Eli Lilly and Company Issues Voluntary Nationwide Recall of One Lot of GLUCAGON® Emergency Kit Due to Loss of Potency.

September 20, 2021

Pfizer Expands Voluntary Nationwide Recall to include All Lots of CHANTIX® (Varenicline) Tablets Due to N-Nitroso Varenicline Content

September 16, 2021- Pfizer is voluntarily recalling all lots of Chantix 0.5 mg and 1 mg tablets to the patient (consumer/user) level due to the presence of a nitrosamine, N-nitroso-varenicline, at or above the FDA interim acceptable intake limit. As alternative suppliers have been approved in the United States, Pfizer is undertaking this precautionary measure.

Nitrosamines are common in water and foods, including cured and grilled meats, dairy products and vegetables. Everyone is exposed to some level of nitrosamines. These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Customers with the affected lots should contact Stericycle Inc. at 888-276-6166 (Mon.-Fri. 7:00 a.m. - 4:00 p.m. CT) for instructions on how to return their product and obtain reimbursement for their cost.

Additional information may be found on the FDA recall website at: Pfizer Expands Voluntary Nationwide Recall to include All Lots of CHANTIX® (Varenicline) Tablets Due to N-Nitroso Varenicline Content.

September 16, 2021

Jacobus Pharmaceutical Company Inc. Issues Voluntary Worldwide Recall of Ruzurgi® 10 mg Tablets Due to Yeast, Mold, and Bacterial Contamination

September 13, 2021- Jacobus Pharmaceutical Company Inc. is voluntarily recalling three lots of (amifampridine) Ruzurgi® 10 mg tablets to the consumer level. The products have been found to be contaminated with yeast, mold and aerobic bacteria based on laboratory test results. Oral products heavily contaminated with yeast, mold and aerobic bacteria may result in serious and life-threatening infections. The use of the defective product in patients with underlying immunosuppressive conditions such as Lambert Eaton Syndrome (LEMS) increases the concern for serious infections.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Consumers with questions regarding this recall can contact Jacobus Pharmaceutical Company Inc. by phone at (609)799-8221 ext. 2120, Monday thru Friday from 9:00 a.m. to 5:00 p.m. Eastern Standard Time.

Additional information may be found on the FDA recall website at: Jacobus Pharmaceutical Company Inc. Issues Voluntary Worldwide Recall of Ruzurgi® 10 mg Tablets.

September 8, 2021

Azurity Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of One Lot of Firvanq® (Vancomycin Hydrochloride for Oral Solution), Vancomycin 50 mg/mL Kit, Due to a Mix-Up of the Diluent Included in the Kit

September 8, 2021- Wilmington, MA, Azurity Pharmaceuticals, Inc. (“Azurity”) is voluntarily recalling one lot of Firvanq® (vancomycin hydrochloride for oral solution) to the consumer level, as some products in the affected lot have been found to incorrectly contain a First Omeprazole (FIRST-PPI) diluent instead of the Firvanq diluent bottle. Vancomycin may not be completely solubilized in the FIRST-PPI diluent which could lead to doses above or below those recommended in the label. There is reasonable probability that the administration of inappropriate doses of oral vancomycin may lead to persistent diarrhea associated with dehydration and electrolyte abnormalities, recurrence of Clostridium difficile (C. difficile) infection, its progression to severe colitis, colon perforation requiring colectomy, and potentially death.

Consumers should contact their physician or health care provider if they have experienced any problems that may be related to taking or using this drug product. Consumers with questions regarding this recall may contact Koral Couch, Senior Manager, Customer Service by phone: 781-935-8141 ext. 119; fax: 781-935-8395 or email: kcouch@azurity.com. Azurity business hours are Monday through Friday from 8:30 a.m. to 5 p.m. Eastern Time.

Additional information may be found on the FDA recall website at: Azurity Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of One Lot of Firvanq® (Vancomycin Hydrochloride for Oral Solution), Vancomycin 50 mg/mL Kit.

September 3, 2021

Janus Kinase (JAK) inhibitors: Drug Safety Communication - FDA Requires Warnings about Increased Risk of Serious Heart-related Events, Cancer, Blood Clots, and Death

September 1, 2021- The FDA is requiring revisions to the Boxed Warning, FDA’s most prominent warning, for Xeljanz/Xeljanz XR (tofacitinib), Olumiant (baricitinib) and Rinvoq (upadacitinib) to include information about the risks of serious heart-related events, cancer, blood clots, and death. Based on the review of a large randomized safety clinical trial, the FDA has concluded there is an increased risk of serious heart-related events with the arthritis and ulcerative colitis medicines Xeljanz and Xeljanz XR. This trial compared Xeljanz with another type of medicine used to treat arthritis called tumor necrosis factor (TNF) blockers in patients with rheumatoid arthritis. The trial’s final results also showed an increased risk of blood clots and death with the lower dose of Xeljanz. The FDA is requiring new and updated warnings for two other arthritis medicines in the same drug class as Xeljanz, called Janus kinase (JAK) inhibitors, Olumiant and Rinvoq.

Two other JAK inhibitors, Jakafi (ruxolitinib) and Inrebic (fedratinib), are not indicated for the treatment of arthritis and other inflammatory conditions and so are not a part of the updates being required to the prescribing information.

Consumers should not stop taking these drugs without first consulting with your health care professionals, as doing so may worsen your condition. Talk to your health care professionals if you have any questions or concerns.

Additional information may be found on the FDA recall website at: Janus Kinase (JAK) inhibitors: Drug Safety Communication.

September 1, 2021

Teligent Pharma, Inc.’s Issues Voluntary Recall of Lidocaine HCl Topical Solution 4% (Lot # 14218, Exp. 09/2022) Due to Super Potency

Aug 30, 2021- Teligent Pharma, Inc. is voluntarily recalling one lot of Lidocaine HCl Topical Solution 4%, 50ml in a screw cap glass bottle to the user level. The product is being recalled because the firm's testing has found it to be super potent based on an Out of Specification (OOS) result obtained at the 18-month stability time point. An increased lidocaine dose could lead to the development of local anesthetic systemic toxicity depending on the duration of the treatment and the specific patient. Local anesthetic systemic toxicity can result in central nervous system reactions including excitation and/or depression and more serious signs of cardiovascular toxicity, such as bradycardia, hypotension, and even cardiovascular collapse can present very quickly.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Consumers with questions regarding this recall can contact Teligent Pharma, Inc. by phone at 1-856-697-1441. Press * to reach the medical information call center Monday through Friday, 8am – 5pm or send an e-mail to Medical@teligent.com.

Additional information may be found on the FDA recall website at: Teligent Pharma, Inc.’s Issues Voluntary Recall of Lidocaine HCl Topical Solution 4% (Lot # 14218, Exp. 09/2022) Due to Super Potency

August 23, 2021

Cardinal Health Issues Nationwide Recall of Select Monoject™ Flush Prefilled Saline Syringes

Aug 19, 2021- Cardinal Health initiated a nationwide recall of approximately 267 million MonojectTM Flush Prefilled Saline Syringes (0.9% Sodium Chloride). The products have been found to reintroduce air into the syringe after the air has been expelled. This could result in injection of air into blood vessels and create the potential for air embolism, which can cause serious adverse health outcomes or death.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Customers who have affected product(s) should immediately review their inventory and quarantine and return all affected product. The recall applies to all lots of the products manufactured from July 2019 to June 2021 distributed between July 2019 and July 2021. Customers with questions may contact the market action team via telephone at 800-292-9332 between the hours of 8 a.m. – 5 p.m. EST. Customers may also contact the team via email at GMB-FieldCorrectiveAction@cardinalhealth.com.

Additional information may be found on the FDA recall website at: Cardinal Health Issues Nationwide Recall of Select Monoject™ Flush Prefilled Saline Syringes.

August 10, 2021

KVK Tech Inc., Issues Voluntary Nationwide Recall of Atovaquone Oral Suspension, USP 750 mg/5mL Due to Temperature Abuse

Aug 6, 2021- KVK Tech, Inc., is voluntarily recalling two lots of Atovaquone Oral Suspension, USP 750 mg/5mLto the consumer level. The recall is based on customer complaints of unusual grittiness in the product, which KVK has determined was most probably caused by prolonged exposure of these product lots to extremely cold weather during shipment. (ADI) level.

Exposure of Atovaquone Oral Suspension to extremely low temperatures, during shipment (the product is required to be protected from freezing temperatures), may result in changes to the effectiveness, appearance, taste and thickness of the liquid. Severely immunocompromised patients who receive less effective Atovaquone Oral Suspension may experience inadequate treatment of serious and life-threatening infections.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Consumers with questions regarding this recall can contact KVK Tech at 215-579-1842 Ext: 6002 Monday – Friday, 8:00 am – 4:30 pm EST or recall@kvktech.com. 

Additional information may be found on the FDA recall website at: KVK Tech Inc., Issues Voluntary Nationwide Recall of Atovaquone Oral Suspension, USP 750 mg/5mL Due to Temperature

July 20, 2021
Pfizer Issues a Voluntary Nationwide Recall for Twelve Lots of CHANTIX® (Varenicline) Tablets Due to N-Nitroso Varenicline Content

July 16, 2021- Pfizer is voluntarily recalling two lots of Chantix 0.5mg Tablets, two lots of Chantix 1 mg Tablets, and eight lots of a Chantix kit of 0.5mg/1 mg Tablets to the patient (consumer/user) level due to the presence of a nitrosamine, N-nitroso-varenicline, above the Pfizer established Acceptable Daily Intake (ADI) level.

Nitrosamines are common in water and foods, including cured and grilled meats, dairy products and vegetables. Everyone is exposed to some level of nitrosamines. These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Customers with the affected lots should contact Stericycle Inc. at 888-276-6166 (Mon.-Fri. 7:00 am - 4:00 pm CT) for instructions on how to return their product and obtain reimbursement for their cost.

Additional information may be found on the FDA recall website at: Pfizer Issues a Voluntary Nationwide Recall for Twelve Lots of CHANTIX® (Varenicline) Tablets Due to N-Nitroso Varenicline Content.

June 14, 2021
Viona Pharmaceuticals Inc., Issues Voluntary Nationwide Recall of Metformin HCl Extended-Release 750 mg Tablets, Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity

June 11, 2021- Viona Pharmaceuticals Inc., is voluntarily recalling 2 (two) lots of Metformin Hydrochloride Extended-Release 750 mg tablets to the retail level. The 2 (two) lots of Metformin Hydrochloride Extended-Release 750 mg tablets have been found to contain levels of Nitrosodimethylamine (NDMA) impurities above acceptable daily limits. This product was manufactured by Cadila Healthcare Limited, Ahmedabad, India in November 2019, for U.S. distribution by Viona Pharmaceuticals Inc.

NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Customers with medical-related questions, who wish to report an adverse event, or quality issues about the products being recalled should contact Viona Pharmaceuticals Inc. by phone at: 888-304-5011, Monday - Friday, 8:30 am – 5:30 pm, EST.

Additional information may be found on the FDA recall website at: Viona Pharmaceuticals Inc., Issues Voluntary Nationwide Recall of Metformin HCl Extended-Release 750 mg Tablets, Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity.

May 3, 2021

Acella Pharmaceuticals, LLC, Issues Voluntary Nationwide Recall of Certain Lots of NP Thyroid® Tablets Due to Sub Potency

April 30, 2021- Acella Pharmaceuticals, LLC, is voluntarily recalling certain lots of 15-mg, 30-mg, 60-mg, 90-mg and 120-mg NP Thyroid®, Thyroid Tablets, USP [levothyroxine (T4) and liothyronine (T3)] to the consumer level. The products are being recalled because routine testing has found these lots to be sub potent. The product contains less than 90% of the labeled amount of liothyronine (T3) and/or levothyroxine (T4). Patients being treated for hypothyroidism (underactive thyroid), who receive sub potent NP Thyroid®, may experience signs and symptoms of hypothyroidism (underactive thyroid) which may include fatigue, increased sensitivity to cold, constipation, dry skin, puffy face, hair loss, slow heart rate, depression, swelling of the thyroid gland and/or unexplained weight gain or difficulty losing weight. There is reasonable risk of serious injury in newborn infants or pregnant women with hypothyroidism including early miscarriage, fetal hyperthyroidism, and/or impairments to fetal neural and skeletal development. In elderly patients and patients with underlying cardiac disease toxic cardiac manifestations of hyperthyroidism may occur, such as cardiac pain, palpitations or cardiac arrhythmia. Patients should talk to their health care professional before they stop taking their NP Thyroid medicine.

Consumers with questions about the recall can email Acella Pharmaceuticals at recall@acellapharma.com or contact our representatives at 1-888-424-4341, Monday through Friday from 8:00 am to 5:00 pm ET. Consumers should contact their physician or health care provider if they have experienced any problems that may be related to taking or using this drug product.

Additional information may be found on the FDA recall website at: Acella Pharmaceuticals, LLC Issues Voluntary Nationwide Recall of Certain Lots of NP Thyroid® Tablets Due to Sub Potency

March 31, 2021

Lamictal (lamotrigine): Drug Safety Communication - Studies Show Increased Risk of Heart Rhythm Problems in Patients with Heart Disease

March 31, 2021- An FDA review of study findings showed a potential increased risk of heart rhythm problems, called arrhythmias, in patients with heart disease who are taking the seizure and mental health medicine Lamictal (lamotrigine). FDA wants to evaluate whether other medicines in the same drug class have similar effects on the heart and are also requiring safety studies on those medicines. FDA will update the public when additional information from these studies becomes available.

Lamotrigine is used alone or with other medicines to treat seizures in patients 2 years and older. It may also be used as maintenance treatment in patients with the mental health condition bipolar disorder to help delay the occurrence of mood episodes such as depression, mania, or hypomania.

Patients should not stop taking their medicine without first talking to their prescriber because stopping lamotrigine can lead to uncontrolled seizures, or new or worsening mental health problems. Patients should contact their health care professional right away or go to an emergency room if they experience an abnormal heart rate or irregular rhythm, or symptoms such as a racing heartbeat, skipped or slow heartbeat, shortness of breath, dizziness, or fainting.

Additional information may be found on the FDA recall website at: Lamictal (lamotrigine): Drug Safety Communication

March 25, 2021

Alembic Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Telmisartan 20 mg Tablets Due to Label Mix-Up

March 24, 2021- Alembic Pharmaceuticals, Inc is voluntarily recalling one lot of Telmisartan 20 mg tablets, packaged in 30-count bottles, Lot No. 1905005661 to the consumer level. The product is being recalled due to a market complaint received which stated that one bottle labelled as 30-count Telmisartan 20 mg tablets, incorrectly contained 30 tablets of Telmisartan 40mg tablets.

Patients who could be on a doubled dose of telmisartan for a prolonged period of time could experience low blood pressure, worsening of kidney function, or an elevation of potassium, which can be life-threatening.

Consumers with questions regarding this recall can contact Alembic Pharmaceuticals Inc by phone at +1 908-552-5839 (9:00 am – 5:00 pm, EDT, Monday through Friday) or email address david.cobb@alembicusa.com. Consumers should contact their physician or health care provider if they have experienced any problems that may be related to taking or using this drug product.

Additional information may be found on the FDA recall website at: Alembic Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Telmisartan 20 mg Tablets Due to Label Mix-Up

March 25, 2021

Benzedrex (propylhexedrine): Drug Safety Communication - FDA Warns that Abuse and Misuse of the Nasal Decongestant Causes Serious Harm

March 25, 2021- The FDA is warning that the abuse and misuse of the over-the-counter (OTC) nasal decongestant propylhexedrine can lead to serious harm such as heart and mental health problems. Some of these complications, which include fast or abnormal heart rhythm, high blood pressure, and paranoia, can lead to hospitalization, disability or death. Reports of individuals abusing and misusing propylhexedrine have increased in recent years. Propylhexedrine is safe and effective when used as directed.

FDA is requesting that all manufacturers of OTC propylhexedrine nasal decongestant inhalers consider product design changes that support its safe use. For example, modifying the product to create a physical barrier that would make tampering with the device and abusing the propylhexedrine inside more difficult. In addition, decreasing the amount of medicine the device contains could also reduce the risk of serious side effects if abused or misused. FDA continues to evaluate this safety issue and will determine if additional FDA actions are needed.

Consumers should only use propylhexedrine according to the directions on the Drug Facts label. Do not use it in ways other than by inhalation because doing so can cause serious harm, such as heart and mental health problems. Some of these problems can lead to death. Ask a pharmacist or your health care professional if you have any questions about propylhexedrine, how to use it, or whether a medicine you are taking may interact with it. Always tell your health care professionals about all medicines you are taking, including OTC medicines.

Additional information may be found on the FDA recall website at: Benzedrex (propylhexedrine): Drug Safety Communication
 

March 10, 2021

Bryant Ranch Prepack Issues Voluntary Nationwide Recall of Spironolactone 25 mg and 50 mg Tablets Due to Mislabeling with the Incorrect Strength

March 09, 2021- Bryant Ranch Prepack is voluntarily recalling 4 lots of Spironolactone tablets to the consumer level. The products have been found to be mislabeled, displaying the incorrect strength. Prepackaged bottles labeled spironolactone 50 mg may contain spironolactone 25 mg tablets and prepackaged bottles of spironolactone 25 mg may contain Spironolactone 50 mg tablets.

A patient who consumes spironolactone 25 mg instead of the prescribed spironolactone 50 mg may experience an elevation in blood pressure or increased swelling caused by excess fluid (edema) if taking the product chronically. It is possible that patients could experience a decrease in potassium if taking half of the expected dose which could lead to Hypokalemia, a condition associated with cardiac arrhythmias. Furthermore, patients who consume spironolactone 50 mg instead of the prescribed spironolactone 25 mg could experience an increase in potassium which could be life-threatening. Patients with renal insufficiency or those taking concomitant renin-angiotensin-aldosterone system (RAAS) inhibitors would be at increased risk.

Consumers with questions regarding this recall can contact Bryant Ranch Prepack at 877-885-0882 Mon.-Fri. 6:30am-6pm PST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Additional information may be found on the FDA recall website at: Bryant Ranch Prepack Issues Voluntary Nationwide Recall of Spironolactone 25 mg and 50 mg Tablets

February 8, 2021

Apotex Corp. Issues Voluntary Nationwide Recall of Enoxaparin Sodium Injection Due to Mislabeling of Syringe Barrel Measurement Markings

February 03, 2021- Apotex Corp is voluntarily recalling two (2) batches of Enoxaparin Sodium Injection to consumer level due to a packaging error resulting in some syringes barrels containing 150 mg/mL markings (corresponding to 120 mg/0.8mL strength) instead of 100 mg/mL markings (corresponding to 100 mg/mL strength) on the syringe barrel and vice versa. The packaging error was discovered during a customer complaint investigation. The affected product is manufactured by Gland Pharma Limited, Hyderabad, India.

Enoxaparin Sodium injection is indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), Treatment of Acute Deep Vein Thrombosis, prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction, when concurrently administered with aspirin and Treatment of Acute ST-Segment Elevation Myocardial Infarction.

Consumers with questions regarding this recall can contact Apotex Corp. by phone at 1-800-706-5575 (8:30am – 5:00pm, EST Monday thru Friday) or email address UScustomerservice@Apotex.com. Consumers should contact their physician or health care provider if they have experienced any problems that may be related to taking or using this drug product.

Additional information may be found on the FDA recall website at: Apotex Corp. Issues Voluntary Nationwide Recall of Enoxaparin Sodium Injection

February 8, 2021

Xeljanz, Xeljanz XR (tofacitinib): Drug Safety Communication - Initial Safety Trial Results Find Increased Risk of Serious Heart-related Problems and Cancer with Arthritis and Ulcerative Colitis Medicine

February 04, 2021- The FDA is alerting the public that preliminary results from a safety clinical trial show an increased risk of serious heart-related problems and cancer with the arthritis and ulcerative colitis medicine Xeljanz, Xeljanz XR (tofacitinib) compared to another type of medicine called tumor necrosis factor (TNF) inhibitors. FDA required the safety trial, which also investigated other potential risks including blood clots in the lungs and death. Those final results are not yet available.

In February 2019 and July 2019, FDA warned that interim trial results showed an increased risk of blood clots and death with the higher 10 mg twice daily dosage, and as a result, approved a Boxed Warning to the tofacitinib prescribing information. The clinical trial is now complete and initial results show a higher occurrence of serious heart-related events and cancer in rheumatoid arthritis (RA) patients treated with both doses of tofacitinib compared to patients treated with a TNF inhibitor. FDA is awaiting additional results from the trial.

Consumers should not stop taking tofacitinib without first consulting with your health care professionals, as doing so may worsen your condition. Talk to your health care professionals if you have any questions or concerns.

Additional information may be found on the FDA recall website at: Xeljanz, Xeljanz XR (tofacitinib): Drug Safety Communication

January 11, 2021

Fresenius Kabi Issues Voluntary Nationwide Recall of Ketorolac Tromethamine Injection, USP Due to the Presence of Particulate Matter

January 8, 2021- Fresenius Kabi USA is voluntarily recalling a single lot of Ketorolac Tromethamine Injection, USP, 30 mg/mL, 1 mL fill in a 2 mL amber vial to the user level due to the presence of particulate matter. Particulate matter was found in reserve sample vials. No adverse event reports have been received for the recalled lot, which was produced and sold in 2019.

Administration of products containing particulate matter could obstruct blood vessels and result in local irritation of blood vessels, swelling at the site of injection, a mass of tissue that could become inflamed and infected, blood clots traveling to the lung, scarring of the lung tissues, and allergic reactions that could lead to life-threatening consequences.

Customers with questions regarding this recall may contact Fresenius Kabi at 1-866-716-2459 Monday through Friday, during the hours of 8:00 a.m. to 5:00 p.m. Central Time. Consumers should contact their physician or health care provider if they have experienced any problems that may be related to taking or using this drug product.

Additional information may be found on the FDA recall website at: Fresenius Kabi Issues Voluntary Nationwide Recall of 13 Lots of Ketorolac Tromethamine Injection

January 11, 2021

Nostrum Laboratories, Inc. Expands Voluntary Nationwide Recall of Metformin HCl Extended Release 750 mg Tablets Due to N-Nitrosodimethylamine (NDMA) Content Above the Acceptable Daily Intake (ADI) Limit

January 4, 2021- Nostrum Laboratories, Inc. is voluntarily recalling one lot of Metformin HCl Extended Release Tablets, USP 750 mg (generic equivalent to Glucophage Tablets) to the consumer level. The Metformin HCl Extended Release Tablets, USP 750 mg (generic equivalent to Glucophage Tablets) have been found to contain levels of nitrosamine impurities above the ADI limit of 96 ng/day as published in the FDA Guidance Document issued September, 2020. This is an expansion of the recall initially announced on November 2, 2020.

NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Consumers with medical questions regarding this recall can contact Nostrum Laboratories, Inc. Medical Affairs at phone number 816-308-4941 or email quality@nostrumpharma.com Monday through Friday from 8am – 5 pm CST.

Additional information may be found on the FDA recall website at: Nostrum Laboratories, Inc. Issues Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release 750mg Tablets, Due to the Detection of N-Nitrosodimethylamine (NDMA)

January 7, 2021

Precision Dose, Inc. Issues Voluntary Nationwide Recall of Paroex Chlorhexidine Gluconate Oral Rinse 0.12% Due to Microbial Contamination

December 31, 2020- Precision Dose, Inc. is voluntarily recalling all lots of Chlorhexidine Gluconate Oral Rinse USP, 0.12%, 15mL Unit Dose Cups bearing an expiration date from 1/31/2021 – 02/28/2022 (see specific lots below) to the consumer level. Precision Dose, Inc. was notified by the manufacturer of the product, Sunstar Americas, Inc., that this product may be contaminated with the bacteria Burkholderia lata. Use of the defective product in the immunocompetent host may result in oral and, potentially, systemic infections requiring antibacterial therapy. In the most at-risk populations, the use of the defective product may result in life-threatening infections, such as pneumonia and bacteremia.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Consumers with questions regarding this recall can contact Precision Dose, Inc. at 1 (800) 397-9228 (Monday-Friday, 8:00 AM to 4:30 PM Central Time) or by email to customercare@precisiondose.com.

Additional information may be found on the FDA recall website at: Precision Dose, Inc. Issues Voluntary Nationwide Recall of Paroex Chlorhexidine Gluconate Oral Rinse 0.12% Due to Microbial Contamination

December 10, 2020

Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Anagrelide Capsules Due to Dissolution Test Failure

December 10, 2020

AvKARE Issues Voluntary Nationwide Recall of Sildenafil 100mg Tablets and Trazodone 100mg Tablets Due to Product Mix-Up

December 9, 2020- AvKARE is voluntarily recalling one lot of Sildenafil 100 mg tablets and one lot of Trazodone 100mg tablets to the consumer level. These products have been recalled due to a product mix-up of the listed two separate products inadvertently packaged together during bottling at a 3rd party facility.

Unintentional consumption of sildenafil may pose serious health risks to consumers with underlying medical issues. For example, sildenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) lowering blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, or heart disease often take nitrates. Unintended intake of trazodone may result in adverse health consequences such as somnolence/sedation, dizziness, constipation, and blurred vision. These adverse events may be more concerning in elderly patients due to a subsequent increased risk for falls and driving impairment.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Consumers with questions regarding this recall can contact AvKARE at 1-855-361-3993 Monday- Friday (8am – 4pm CST).

Additional information may be found on the FDA recall website at: AvKARE Issues Voluntary Nationwide Recall of Sildenafil 100mg Tablets and Trazodone 100mg Tablets Due to Product Mix-Up

November 11, 2020

Lohxa LLC Issues Voluntary Nationwide Recall of Chlorhexidine Gluconate Oral Rinse USP, 0.12% Due to Microbial Contamination

November 9, 2020- Lohxa, LLC is voluntarily recalling Chlorhexidine Gluconate 0.12% Oral Rinse Alcohol free products bearing an expiration date from 01/31/21 – 03/31/21 to the consumer level. This product is sourced and repackaged from Sunstar Americas Inc. who has notified us the product may be contaminated with the bacteria Burkholderia lata. Use of the defective product in the immunocompetent host may result in oral and, potentially, systemic infections requiring antibacterial therapy. In the most at-risk populations, the use of the defective product may result in life-threatening infections, such as pneumonia and bacteremia.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Consumers with questions regarding this recall can contact Lohxa, LLC by phone at 1-800-641-5564 or email info@lohxa.com on Monday-Friday from 8am-5pm EST.

Additional information may be found on the FDA recall website at: Lohxa LLC Issues Voluntary Nationwide Recall of Chlorhexidine Gluconate Oral Rinse USP, 0.12% Due to Microbial Contamination

November 3, 2020

Nostrum Laboratories, Inc. Issues Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release 500mg & 750mg Tablets, Due to the Detection of N-Nitrosodimethylamine (NDMA)

November 02, 2020- Nostrum Laboratories, Inc. is voluntarily recalling 2 (two) lots of Metformin HCl Extended Release 500 mg tablets and 2 (two) lots of Metformin HCl Extended Release 750 mg tablets to the consumer level. The Metformin HCl Extended Release tablets have been found to contain levels of nitrosamine impurities above the ADI limit of 96 ng/day as published in the FDA Guidance Document issued September, 2020.

NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Consumers with medical questions regarding this recall can contact Nostrum Laboratories, Inc. Medical Affairs at phone number 816-308-4941 or email quality@nostrumpharma.com Monday through Friday from 8am – 5 pm CST.

Additional information may be found on the FDA recall website at: Nostrum Laboratories, Inc. Issues Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release 500mg & 750mg Tablets, Due to the Detection of N-Nitrosodimethylamine (NDMA)
 
November 2, 2020
Sunstar Americas Inc. Issues Voluntary Nationwide Recall of Paroex® Chlorhexidine Gluconate 0.12% Oral Rinse Due to Microbial Contamination

October 28, 2020- Sunstar Americas, Inc. (SAI) is voluntarily recalling Paroex® Chlorhexidine Gluconate 0.12% Oral Rinse products bearing an expiration date from 6/30/22 – 9/30/22 to the consumer level. This product may be contaminated with the bacteria Burkholderia lata. Use of the defective product in the immunocompetent host may result in oral and, potentially, systemic infections requiring antibacterial therapy. In the most at-risk populations, the use of the defective product may result in life-threatening infections, such as pneumonia and bacteremia.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Consumers with questions regarding this recall can contact SAI by phone at 1-800-528-8537 or email us.pcr@us.sunstar.com on Monday-Friday from 8am-5pm CST.

Additional information may be found on the FDA recall website at: Sunstar Americas Inc. Issues Voluntary Nationwide Recall of Paroex® Chlorhexidine Gluconate 0.12% Oral Rinse Due to Microbial Contamination

October 8, 2020

Marksans Pharma Limited Issues Expansion of Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets, USP 500mg & 750mg, Due to the Detection of N-Nitrosodimethylamine (NDMA)

October 5, 2020- Marksans Pharma Limited, India is voluntarily expanding its earlier initiated recall on June 05, 2020 to include an additional 76 unexpired lots of Metformin Hydrochloride Extended-Release Tablets, USP 500mg, & 750mg to the consumer level. Marksans performed N-Nitrosodimethylamine (NDMA) testing of unexpired identified marketed lots and observed that NDMA content in some lots is exceeding the acceptable Daily Intake Limit (ADI) of 96ng/day, therefore, out of an abundance of caution, an additional 76 lots are being recalled.

NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Consumers with questions regarding this recall and return can contact Ms. Irene McGregor (Vice President, Regulatory Affairs) of Time-Cap Labs, Inc., located at 7 Michael Avenue, Farmingdale, New York 11735, by phone number 631-753-9090; ext. 160, Monday to Friday 8am-5pm EST or e-mail address imcgregor@timecaplabs.com.

Additional information may be found on the FDA recall website at: Marksans Pharma Limited Issues Expansion of Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets, USP 500mg & 750mg, Due to the Detection of N-Nitrosodimethylamine (NDMA)

September 30, 2020

Benadryl (diphenhydramine): Drug Safety Communication - Serious Problems with High Doses of the Allergy Medicine

June 18, 2020- FDA is warning that taking higher than recommended doses of the common over-the-counter (OTC) allergy medicine Benadryl (diphenhydramine) can lead to serious heart problems, seizures, coma, or even death. FDA is aware of news reports of teenagers ending up in emergency rooms or dying after participating in the “Benadryl Challenge” encouraged in videos posted on the social media application TikTok.

FDA is investigating these reports and conducting a review to determine if additional cases have been reported. FDA will update the public once the review is complete or if there is more information to share.

Consumers, parents, and caregivers should store diphenhydramine and all other OTC and prescription medicines up and away and out of children’s reach and sight. FDA recommends you lock up medicines to prevent accidental poisonings by children and misuse by teens, especially when they are home more often due to the COVID-19 pandemic and may be more likely to experiment. If someone takes too much diphenhydramine and is hallucinating, can’t be awakened, has a seizure, has trouble breathing, or has collapsed, immediately get medical attention or contact poison control at 1-800-222-1222

Additional information may be found on the FDA recall website at: Benadryl (diphenhydramine): Drug Safety Communication - Serious Problems with High Doses of the Allergy Medicine

September 24, 2020

Sun Pharmaceutical Industries, Inc. Issues Voluntary Nationwide Recall of RIOMET ER™ (Metformin Hydrochloride for Extended-Release Oral Suspension) Due to N-Nitrosodimethylamine (NDMA) Content Above the Acceptable Daily Intake (ADI) Limit

September 23, 2020- Sun Pharmaceutical Industries, Inc. (SUN PHARMA), a wholly owned subsidiary of Sun Pharmaceutical Industries Ltd. is voluntarily recalling one lot of RIOMET ER™ (metformin hydrochloride for extended-release oral suspension), 500 mg per 5 mL to the consumer level. The reason for the recall is due to the level of N-Nitrosodimethylamine (NDMA), which has been found to be above the allowable Acceptable Daily Intake (ADI) limit established by the U.S. Food and Drug Administration.

NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Consumers with questions regarding this recall can contact SUN PHARMA by calling 1-800-818-4555 Monday through Friday between 8:00 am to 5:00 pm EST or e-mailing drug.safetyUSA@sunpharma.com.

Additional information may be found on the FDA recall website at: Sun Pharmaceutical Industries, Inc. Issues Voluntary Nationwide Recall of RIOMET ER™ (Metformin Hydrochloride for Extended-Release Oral Suspension)

September 22, 2020

FDA Alerts of Perrigo's voluntary albuterol inhaler recall

September 21, 2020- The U.S. Food and Drug Administration is alerting health care professionals and patients of a voluntary recall of all unexpired albuterol sulfate inhalation aerosol manufactured by Catalent Pharma Solutions for Perrigo Pharmaceutical Company in Minneapolis, due to possible clogging of the inhaler resulting in patients not receiving enough or any medicine. This recall is to the retail level. FDA urges patients to continue using the inhaler they have on hand.

Perrigo informed FDA it has received several thousand complaints about its product. Most of the complaints were for clogging and failure to dispense enough medicine. The manufacturer of Perrigo’s albuterol inhaler, Catalent, stopped producing and distributing the albuterol inhaler products on August 21, 2020, and is currently investigating the malfunction.

The agency asks health care professionals and patients to report unexpected side effects or quality problems associated with albuterol inhalers to FDA’s MedWatch Adverse Event Reporting program www.fda.gov/medwatch/report.htm

Additional information may be found on the FDA recall website at: FDA Alerts of Perrigo's voluntary albuterol inhaler recall

September 18, 2020

Acella Pharmaceuticals, LLC Issues Voluntary Nationwide Recall of Two Lots of NP Thyroid® Tablets Due to Sub Potency

September 17, 2020- Acella Pharmaceuticals, LLC is voluntarily recalling one lot of 15-mg and one lot of 120-mg NP Thyroid® Tablets [levothyroxine (T4) and liothyronine (T3)] to the consumer level. The products are being recalled because testing has found these lots to be sub potent. The product may have as low as 87% of the labeled amount of levothyroxine (T4). Patients being treated for hypothyroidism (underactive thyroid), who receive sub potent NP Thyroid®, may experience signs and symptoms of hypothyroidism (underactive thyroid) which may include, fatigue, increased sensitivity to cold, constipation, dry skin, puffy face, hair loss, slow heart rate, depression, swelling of the thyroid gland and/or unexplained weight gain or difficulty losing weight. There is reasonable risk of serious injury in newborn infants or pregnant women with hypothyroidism including early miscarriage, fetal hyperthyroidism, and/or impairments to fetal neural and skeletal development. In elderly patients and patients with underlying cardiac disease toxic cardiac manifestations of hyperthyroidism may occur, such as cardiac pain, palpitations or cardiac arrhythmia. Patients should talk to their healthcare professional before they stop taking their NP Thyroid medicine.

Consumers with questions about the recall can email Acella Pharmaceuticals at recall@acellapharma.com or contact our representatives at 1-888-280-2044, Monday through Friday from 8:00 am to 5:00 pm ET. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Additional information may be found on the FDA recall website at: Acella Pharmaceuticals, LLC Issues Voluntary Nationwide Recall of Two Lots of NP Thyroid® Tablets Due to Sub Potency

September 10, 2020

RLC Labs, Inc., Issues Voluntary Nationwide Recall of All Lots of Nature-Throid® and WP Thyroid® with Current Expiry Due to Sub Potency

September 3, 2020- RLC Labs, Inc. is voluntarily recalling a total of 483 lots of Nature-Throid® and WP Thyroid® in all strengths, all counts of product within current expiry to the consumer level. The products are being recalled because testing by the U.S. Food and Drug Administration found the samples to be sub potent. The product may have as low as 87% of the labeled amount of Liothyronine (T3) or Levothyroxine(T4).

Consumers with questions about the recall can email RLC Labs, Inc. at recall@rlclabs.com or contact RLC Labs, Inc. Customer Service at 1-877-797-7997, Monday through Thursday from 7:00 am to 4:00 pm MST (AZ) and Friday from 7:00 am to 3:00 pm MST (AZ).Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Additional information may be found on the FDA recall website at: RLC Labs, Inc., Issues Voluntary Nationwide Recall of All Lots of Nature-Throid® and WP Thyroid® with Current Expiry Due to Sub Potency

August 21, 2020

Bayshore Pharmaceuticals, LLC Issues Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release 500 mg and 750 mg Tablets, Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity

August 19, 2020- Bayshore Pharmaceuticals, LLC is voluntarily recalling one (1) lot of Metformin Hydrochloride Extended-Release 500 mg Tablets, 1000 count bottles and one (1) lot of Metformin Hydrochloride Extended-Release 750 mg Tablets, 100 count bottles within expiry to the consumer level due to the detection of N-Nitrosodimethylamine (NDMA) levels above the Acceptable Daily Intake Limit.

NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Additional information may be found on the FDA recall website at: Bayshore Pharmaceuticals, LLC Issues Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release 500 mg and 750 mg Tablets, Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity

August 7, 2020

Ferring US Issues Voluntary Nationwide Recall of DDAVP® Nasal Spray 10 mcg/0.1mL, Desmopressin Acetate Nasal Spray 10 mcg/0.1mL, STIMATE® Nasal Spray 1.5 mg/mL Due to Superpotency

August 5, 2020- Ferring Pharmaceuticals US is voluntarily recalling all lots on the market of DDAVP® Nasal Spray 10 mcg/0.1mL, Desmopressin Acetate Nasal Spray 10 mcg/0.1mL, and STIMATE® Nasal Spray 1.5 mg/mL to the consumer level. These products are being recalled due to superpotency or amounts of desmopressin higher than specified. These out of specification results were obtained during routine testing.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Consumers, wholesalers, distributors, and retailers with questions regarding this recall should call Stericycle at 1-888-228-5053.

Additional information may be found on the FDA recall website at: Ferring US Issues Voluntary Nationwide Recall of DDAVP® Nasal Spray 10 mcg/0.1mL, Desmopressin Acetate Nasal Spray 10 mcg/0.1mL, STIMATE® Nasal Spray 1.5 mg/mL Due to Superpotency
 

July 7, 2020

Granules Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release 750 mg Tablets, Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity

July 6, 2020- Granules Pharmaceuticals, Inc., Chantilly, VA is voluntarily recalling twelve (12) lots of Metformin Hydrochloride Extended-Release 750 mg Tablets, 100 and 500 count bottles within expiry to the consumer level due to the detection of NNitrosodimethylamine (NDMA) levels above the Acceptable Daily Intake Limit.

NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Additional information may be found on the FDA recall website at: Granules Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release 750 mg Tablets Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity

June 22, 2020

GSK Consumer Healthcare Issues Voluntary Nationwide Recall of Children's Robitussin® Honey Cough and Chest Congestion DM and Children's Dimetapp® Cold and Cough Due to Dosing Cups Missing Some Graduation Markings

June 18, 2020- GSK Consumer Healthcare is voluntarily recalling to the retail level two lots (listed below) of Children's Robitussin® Honey Cough and Chest Congestion DM and one lot of Children's Dimetapp® Cold and Cough, due to the inclusion of incorrect dosing cups. During the review of the packaging documents for these products, GSK discovered that the dosing cups for the Children's Robitussin® Honey product are missing the 5 mL and 10 mL graduations, while the dosing cups for the Children's Dimetapp® product are missing the 10 mL graduation. The dosing cups packaged with both products only have the 20 mL graduation.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product. Consumers with questions regarding this recall or to report an adverse experience please call 1-800-762-4675, Monday – Friday, 8:00am – 6:00pm EST.

Additional information may be found on the FDA recall website at: GSK Consumer Healthcare Issues Voluntary Nationwide Recall of Children's Robitussin® Honey Cough and Chest Congestion DM and Children's Dimetapp® Cold and Cough Due to Dosing Cups Missing Some Graduation Markings

June 11, 2020

Lupin Pharmaceuticals, Inc. Issues Voluntarily Nationwide Recall of One Lot of Metformin Hydrochloride Extended-Release 500mg Tablets Due to the Detection of N-Nitrosodimethylamine (NDMA)

June 11, 2020- Lupin Pharmaceuticals Inc. is voluntarily recalling Metformin Hydrochloride Extended-Release 500mg tablets to the consumer level. FDA analysis revealed that this lot exceeded the Acceptable Daily Intake Limit for the impurity N-Nitrosodimethylamine (NDMA).

NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Consumers, wholesalers, distributors, and retailers with questions regarding this recall should contact Inmar Rx Solutions, Inc. at (855) 532-1856 Monday – Friday 09:00 am to 05:00 pm EST.

Additional information may be found on the FDA recall website at: Lupin Pharmaceuticals, Inc. Issues Voluntarily Nationwide Recall of One Lot of Metformin Hydrochloride Extended-Release 500mg Tablets Due to the Detection of NDMA

June 8, 2020

Marksans Pharma Limited Issues Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release 500mg Tablets Due to the Detection of N-Nitrosodimethylamine (NDMA)

June 5, 2020- Marksans Pharma Limited, India is voluntarily recalling Metformin Hydrochloride Extended-Release 500mg tablets, lot # XP9004, to the consumer level. FDA analysis has found the product to contain N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit (ADI) of 96ng/day.

NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Consumers with questions regarding this recall and return can contact Ms. Irene McGregor (Vice President, Regulatory Affairs) of Time-Cap Labs, Inc., located at 7 Michael Avenue, Farmingdale, New York 11735, by phone number 631-753-9090; ext. 160, Monday to Friday 8am-5pm EST or e-mail address imcgregor@timecaplabs.com.

Additional information may be found on the FDA recall website at: Marksans Pharma Limited Issues Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release 500mg Tablets Due to the Detection of N-Nitrosodimethylamine (NDMA)

June 8, 2020

Teva Pharmaceuticals USA, Inc. Initiates Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release 500 mg and 750 mg Tablets Due to Detection of N-Nitrosodimethylamine (NDMA)

June 5, 2020- Teva Pharmaceuticals USA, Inc. is voluntarily recalling fourteen (14) lots of Metformin Hydrochloride Extended-Release 500 mg and 750 mg tablets, in the United States to the consumer-level due to the detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit (ADI).

NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Customers and patients with medical-related questions, who wish to report an adverse event, or quality issues about the Teva products being recalled should contact Teva Medical Information by phone at: 888-838-2872, option 3, then, option 4. Live calls are received Monday-Friday, 9:00 am to 5:00 pm Eastern Time with voicemail available 24 hours/day, 7 days/week or by email at druginfo@tevapharm.com.

Additional information may be found on the FDA recall website at: Teva Pharmaceuticals USA, Inc. Initiates Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release 500 mg and 750 mg Tablets Due to Detection of N-Nitrosodimethylamine (NDMA)

June 4, 2020

Epinephrine Auto-Injector Devices by Amneal and Impax: CDER Alert - FDA Alerts Patients and Health Care Professionals About Device Malfunction

June 1, 2020- FDA is alerting patients, caregivers and health care professionals to immediately inspect certain lots of Amneal and Impax epinephrine auto-injector 0.3 mg to ensure the yellow “stop collar” in the device is present. If the auto-injector is missing the yellow “stop collar” component, the device has the potential safety risk of delivering a double dose of epinephrine to a patient.

Patients, pharmacists and health care professionals who have received Amneal or Impax’s epinephrine auto-injector after December 20, 2018, should immediately visually inspect the auto-injector to confirm the presence of the yellow “stop collar”. Epinephrine auto-injectors are not being recalled. FDA urges patients to use the epinephrine auto-injector they have on hand and be aware of the potential issues.

Additional information may be found on the FDA recall website at: Epinephrine Auto-Injector Devices by Amneal and Impax: CDER Alert - FDA Alerts Patients and Health Care Professionals About Device Malfunction

June 1, 2020

Amneal Pharmaceuticals LLC Issues Voluntary Nationwide Recall of Metformin Hydrochloride Extended Release 500 mg and 750 mg Tablets, Due to Detection of N-Nitrosodimethylamine (NDMA) Impurity

June 1, 2020- Amneal Pharmaceuticals LLC Bridgewater, is voluntarily recalling all lots of Metformin Hydrochloride Extended Release 500 mg and 750 mg tablets, within expiry to the Retail Level. Amneal was notified by the U.S. FDA that the Agency’s testing of seven lots of Metformin Hydrochloride Extended Release 500 mg and 750 mg tablets showed N-Nitrosodimethylamine (NDMA) amounts above acceptable FDA levels. FDA recommended the recall of the seven tested lots. Amneal has agreed to this recall and has further decided to extend the recall to all lots within expiry of Metformin Hydrochloride Extended Release 500 mg and 750 mg tablets out of an abundance of caution. Further scientific evaluations are ongoing at Amneal.

NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Additional information may be found on the FDA recall website at: Amneal Pharmaceuticals LLC Issues Voluntary Nationwide Recall of Metformin Hydrochloride Extended Release 500 mg and 750 mg Tablets, Due to Detection of N-Nitrosodimethylamine (NDMA)

June 1, 2020

Apotex Corp. Issues Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets 500mg Due to the Detection of N-nitrosodimethylamine (NDMA)

May 27, 2020- Apotex Corp is voluntarily recalling all lots of Metformin Hydrochloride Extended-Release 500mg Tablets within expiry to retail level. Apotex was notified by the U.S. Food and Drug Administration (US FDA) that one lot of Metformin Hydrochloride Extended-Release Tablets, USP was tested and showed results for N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit (ADI) and recommended recall of the one tested lot. Apotex Corp has agreed to recall this lot, and out of an abundance of caution, the company is extending the recall to all lots of Metformin Hydrochloride Extended-Release Tablets in the US. Apotex stopped selling this product in the US in February 2019, and there remains only limited product on the market.

NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.

Consumers with questions regarding this recall can contact Apotex Corp. by phone at 1-800-706-5575 (8:30am – 5:00pm, EST Monday thru Friday) or email address UScustomerservice@Apotex.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Additional information may be found on the FDA recall website at: Apotex Corp. Issues Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets 500mg Due to the Detection of N-nitrosodimethylamine (NDMA)

May 26, 2020

Acella Pharmaceuticals, LLC Issues Voluntary Nationwide Recall of Certain Lots of NP Thyroid® Due to Super Potency

May 22, 2020- Acella Pharmaceuticals, LLC is voluntarily recalling a total of 13 lots of 30-mg, 60-mg and 90-mg NP Thyroid® to the consumer level. The products are being recalled because our testing has found these lots to be superpotent. The product may have up to 115.0% of the labeled amount of Liothyronine (T3). Patients being treated for hypothyroidism (underactive thyroid), who receive superpotent NP Thyroid, may experience signs and symptoms of hyperthyroidism (overactive thyroid) which include, but are not limited to, weight loss, heat intolerance, fatigue, muscle weakness, hypertension, chest pain, rapid heart rate, or heart rhythm disturbances. Pregnant women who take superpotent NP Thyroid may also experience negative maternal and fetal outcomes including miscarriage and/or impairment to fetal development. Patients should talk to their healthcare professional before they stop taking their NP Thyroid medicine.

Consumers with questions about the recall can email Acella Pharmaceuticals at recall@acellapharma.com or contact Acella Customer Service at 1-800-541-4802, Monday through Thursday from 9:00 am to 5:00 pm ET and Friday from 9:00 am to 12:30 pm ET. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Additional information may be found on the FDA recall website at: Acella Pharmaceuticals, LLC Issues Voluntary Nationwide Recall of Certain Lots of NP Thyroid® Due to Super Potency

April 22, 2020

Fresenius Kabi Issues Voluntary Nationwide Recall of 13 Lots of Ketorolac Tromethamine Injection, USP Due to the Presence of Particulate Matter in Reserve Samples

April 20, 2020- Fresenius Kabi USA, LLC is voluntarily recalling 13 lots of Ketorolac Tromethamine Injection, 30 mg/mL and 60 mg/2 mL amber vial to the user level due to the presence of particulate matter composed of the following elements: carbon, silicon, oxygen and polyamides.

Administration of products containing particulate matter could obstruct blood vessels and result in local irritation of blood vessels, swelling at the site of injection, a mass of tissue that could become inflamed and infected, blood clots traveling to the lung, scarring of the lung tissues, and allergic reactions that could lead to life-threatening consequences.

Customers with questions regarding this recall may contact Fresenius Kabi at 1-866-716-2459 Monday through Friday, during the hours of 8:00 a.m. to 5:00 p.m. Central Time. Consumers should contact their physician or health care provider if they have experienced any problems that may be related to taking or using this drug product.

Additional information may be found on the FDA recall website at: Fresenius Kabi Issues Voluntary Nationwide Recall of 13 Lots of Ketorolac Tromethamine Injection

April 17, 2020

International Laboratories, LLC Issues Voluntary Nationwide Recall of One (1) Lot of Clopidogrel Tablets 75 mg Packaged in Bottles of 30 Tablets Due to Mislabeling

April 15, 2020- International Laboratories, LLC is voluntarily recalling Lot# 117099A of Clopidogrel Tablets, USP 75 mg, packaged in bottles of 30 tablets, to the consumer level due to mislabeling. The product is labeled as Clopidogrel tablets USP 75 mg but may contain Clopidogrel 75mg or Simvastatin Tablets USP 10 mg.

Consumers should also contact their physician or healthcare provider if they are experiencing any health concerns that may be related to taking or using this drug product.

For questions regarding return of product please call Inmar at 855-258-7280 or via email internationallabs@inmar.com or by using mailing address Recall Coordinator 635 Vine St. Winston Salem, NC 27101 Inmar’s business hours are (Monday – Friday 9 AM – 5 PM EST).

Additional information may be found on the FDA recall website at: International Laboratories, LLC Issues Voluntary Nationwide Recall of Clopidogrel Tablets 75 mg

April 17, 2020

Avet Pharmaceuticals Inc. Issues Voluntary Nationwide Recall of Tetracycline HCl Capsules USP, 250 mg and 500 mg Due to Failed Dissolution Specifications

April 15, 2020- Avet Pharmaceuticals Inc. is initiating a voluntary recall of certain lots of Tetracycline HCl 250 mg and 500 mg Capsules. The voluntary recall is being initiated due to low out of specification dissolution test results. Low dissolution results in less tetracycline available in the body to fight infection. This can lead to treatment failures. For patients with compromised immune systems and the elderly, who may be taking tetracycline to treat a serious infection such as pneumonia, there is a reasonable probability that if there is not enough tetracycline in the body to fight the infection, this could result in rapid progression of the infection and death.

Consumers with questions regarding this recall should contact Qualanex at 1-888-424-4341. Monday – Friday, 8:00 am – 5:00 pm, EST and or recall@qualanex.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Additional information may be found on the FDA recall website at: Avet Pharmaceuticals Inc. Issues Voluntary Nationwide Recall of Tetracycline HCl Capsules

April 17, 2020

Amneal Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Nizatidine Oral Solution, 15 mg/mL, Due to Potential Levels of N-nitrosodimethylamine (NDMA) Impurity Amounts Above the Levels Established by FDA

April 15, 2020- Amneal Pharmaceuticals, LLC is voluntarily recalling three lots of Nizatidine Oral Solution 15 mg/mL, packaged in 480 mL bottles to the Consumer Level. Nizatidine Oral Solution was distributed by Gemini Laboratories, LLC, a wholly owned subsidiary of Amneal Pharmaceuticals. Nizatidine Oral Solution is being recalled due to potential N-Nitrosodimethylamine (NDMA) amounts exceeding the levels established by the FDA.

NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products and vegetables. NDMA has been classified as a probable human carcinogen (a substance that could cause cancer) according to the International Agency for Research on Cancer (IARC).

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to the use of this drug product.

Consumers who have Nizatidine Oral Solution which is being recalled should stop using the product and can call Inmar at 855-319-4807, Monday – Friday, 8:00 am – 5:00 pm, EST for further information.

Additional information may be found on the FDA recall website at: Amneal Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Nizatidine Oral Solution, 15 mg/mL

April 1, 2020

All Ranitidine Products (Zantac): Press Release - FDA Requests Removal

April 1, 2020- The FDA announced it is requesting manufacturers to withdraw all prescription and over-the-counter (OTC) ranitidine drugs from the market immediately.
This is the latest step in an ongoing investigation of a contaminant known as N-Nitrosodimethylamine (NDMA) in ranitidine medications (commonly known by the brand name Zantac). NDMA is a probable human carcinogen (a substance that could cause cancer). FDA has determined that the impurity in some ranitidine products increases over time and when stored at higher than room temperatures may result in consumer exposure to unacceptable levels of this impurity. As a result of this immediate market withdrawal request, ranitidine products will not be available for new or existing prescriptions or OTC use in the U.S.

Patients taking prescription ranitidine should speak with their health care professional about other treatment options before stopping the medicine, as there are multiple drugs approved for the same or similar uses as ranitidine that do not carry the same risks from NDMA. To date, the FDA’s testing has not found NDMA in famotidine (Pepcid), cimetidine (Tagamet), esomeprazole (Nexium), lansoprazole (Prevacid) or omeprazole (Prilosec).

Additional information may be found on the FDA recall website at: All Ranitidine Products (Zantac): Press Release - FDA Requests Removal

March 5, 2020

Singulair (montelukast) and All Montelukast Generics: Strengthened Boxed Warning - Due to Restricting Use for Allergic Rhinitis

March 5, 2020- The FDA is strengthening existing warnings about serious behavior and mood-related changes with montelukast (Singulair and generics), which is a prescription medicine for asthma and allergy. FDA is taking this action after a review of available information that led us to reevaluate the benefits and risks of montelukast use. Montelukast prescribing information already includes warnings about mental health side effects, including suicidal thoughts or actions; however, many health care professionals and patients/caregivers are not aware of the risk. We decided a stronger warning is needed after conducting an extensive review of available information and convening a panel of outside experts, and therefore determined that a Boxed Warning was appropriate.

Patients should talk with your health care professional about:

• The benefits and risks of montelukast, as many other safe and effective allergy medicines are widely available.
• Any history of mental illness before starting treatment.

Additional information may be found on the FDA recall website at: Singulair (montelukast) and All Montelukast Generics: Strengthened Boxed Warning - Due to Restricting Use for Allergic Rhinitis

February 27, 2020

Taro Pharmaceuticals U.S.A. Issues Voluntary Nationwide Recall of Phenytoin Oral Suspension USP, 125 mg/5ml Due to Possible Underdosing or Overdosing

February 20, 2020 - Taro Pharmaceuticals is voluntarily recalling two (2) lots of Phenytoin Oral Suspension USP, 125 mg/5 mL in 237 mL bottles. The reason for the recall is that product may not re-suspend when shaken which could result in under or overdosing.

Patients should contact their physician or health professional if they have experienced any problems that may be related to taking or using this drug product. Consumers with questions regarding this recall can contact Taro by calling 1-866-705-1553 or by e-mail at TaroPVUS@taro.com, Monday through Friday between 7:00 am and 7:00 pm, U.S. Central Time.

Additional information may be found on the FDA recall website at: Taro Pharmaceuticals U.S.A. Issues Voluntary Nationwide Recall of Phenytoin Oral Suspension

February 27, 2020

American Health Packaging Issues Voluntary Nationwide Recall of Ranitidine Tablets, USP 150 mg, 100 Count Unit Dose Blisters Due to the Detection of N-nitrosodimethylamine (NDMA) Impurity

February 27, 2020- American Health Packaging has voluntarily recalled eleven (11) lots of Ranitidine tablets 150 mg, 100 count Unit Dose Blisters to the consumer level due to the potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA. NDMA is classified as a probable human carcinogen (a substance that could cause cancer). This recall was initiated in response to the recall by the manufacturer (Amneal Pharmaceuticals, LLC), which included affected lots that were repackaged by American Health Packaging.

Patients who have Ranitidine tablets which are being recalled should stop using the product or with questions regarding this recall can contact Inmar Pharmaceuticals Services by 800-967-5952 (option 1). Hours of operation are 9:00 am - 5:00 pm, EST Monday through Friday.

Additional information may be found on the FDA recall website at: American Health Packaging Issues Voluntary Nationwide Recall of Ranitidine Tablets

February 14, 2020

Belviq, Belviq XR (lorcaserin): Drug Safety Communication - FDA Requests Withdrawal of Weight-Loss Drug

February 13, 2020- The FDA has requested that the manufacturer, Eisai Inc., of Belviq, Belviq XR (lorcaserin) voluntarily withdraw the weight-loss drug from the U.S. market because a safety clinical trial shows an increased occurrence of cancer. The drug manufacturer has submitted a request to voluntarily withdraw the drug.

Patients should stop taking lorcaserin and talk to your health professionals about alternative weight-loss medicines and weight management programs.

Additional information may be found on the FDA recall website at: Belviq, Belviq XR (lorcaserin): Drug Safety Communication - FDA Requests Withdrawal of Weight-Loss Drug

January 14, 2020

Belviq, Belviq XR (lorcaserin): Drug Safety Communication - Due to Possible Increased Risk of Cancer

January 14, 2020- The FDA is alerting the public that results from a clinical trial assessing safety show a possible increased risk of cancer with the weight management medicine Belviq, Belviq XR (lorcaserin). At this time, the cause of the cancer is uncertain, and we cannot conclude that lorcaserin contributes to the cancer risk.

Patients currently taking lorcaserin should talk to their health care professionals about the potential increased risk of cancer with use of lorcaserin.

Additional information may be found on the FDA recall website at: Belviq, Belviq XR (lorcaserin): Drug Safety Communication - Due to Possible Increased Risk of Cancer

January 13, 2020

Taro Pharmaceuticals U.S.A., Inc. Issues Voluntary Nationwide Recall of Lamotrigine Tablets USP, 100 mg, 100 Count Bottles

January 10, 2020- Taro Pharmaceuticals U.S.A., Inc. is voluntarily recalling one lot of Lamotrigine 100 mg Tablets, Lot # 331771 (expiration date June 2021) in 100 count bottles, NDC 51672-4131-1 to the consumer level. This single lot was found to have been cross-contaminated with a small amount of another drug substance, Enalapril Maleate, used to manufacture another product at the same facility.

Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Consumers with questions regarding this recall can contact Taro by calling 1-866-923-4914 or by e-mail at TaroPVUS@taro.com, Monday through Friday between 7:00 AM and 7:00 PM US Central Time.

Additional information may be found on the FDA recall website at: Taro Pharmaceuticals U.S.A., Inc. Issues Voluntary Nationwide Recall of Lamotrigine Tablets

January 8, 2020

Appco Pharma LLC Issues Voluntary Nationwide Recall of Ranitidine Hydrochloride Capsules 150 mg and 300 mg Due to an Elevated Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA)

January 07, 2020- Appco Pharma LLC (Appco) is voluntarily recalling all quantities and lots, within expiry, of Ranitidine Hydrochloride Capsules to the Consumer level. Ranitidine Hydrochloride Capsules are being recalled because of the presence or potential presence of N-nitrosodimethylamine (NDMA) levels above the acceptable daily intake levels established by the FDA, based on FDA-validated tests. To date, Appco has not received any reports of adverse events related to use of the product as part of this recall.

Patients who were prescribed or are taking Ranitidine 150mg or 300mg capsules should stop using/return to place of purchase and speak to their physician or pharmacist about alternate healthcare treatment options. Multiple drugs are approved for the same or similar uses as ranitidine. It is important to remember that not all ranitidine marketed in the U.S. is being recalled.

Consumers with questions regarding this recall can contact Appco at: (732) 253-7735 between 8 am and 6 pm (EST) (Monday-Friday) or e-mail: pv@appcopharma.com or at ANI Pharmaceuticals, Inc. at 1-800-308-6755 or PVSupport@safetycall.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Additional information may be found on the FDA recall website at: Appco Pharma LLC Issues Voluntary Nationwide Recall of Ranitidine Hydrochloride Capsules

January 8, 2020

Denton Pharma, Inc. dba Northwind Pharmaceuticals Voluntarily Recalls All Unexpired Lots of its Ranitidine Tablets and Ceases Distribution

January 8, 2020 - Denton Pharma, Inc. announced a voluntary recall of Ranitidine tablets to the consumer level due to possible presence of N-nitrosodimethylamine (NDMA) impurity.

Patients who have Ranitidine Tablets, USP subject to this recall should immediately discontinue use, discard remaining product and consult with their physician or healthcare provider about treatment options.

Consumers who would like to report any adverse reactions or quality problems experienced as a result of their use of this product, or have questions regarding the use of Ranitidine Tablets, USP can contact Northwind at 1-800-722-0772 Monday – Friday, 9:00 am – 5:00 pm, EST.

Additional information may be found on the FDA recall website at: Denton Pharma, Inc. Issues Voluntary Nationwide Recall of Ranitidine

January 8, 2020

Mylan Initiates Voluntary Nationwide Recall of Three Lots of Nizatidine Capsules, USP, Due to the Detection of Trace Amounts of NDMA (N-Nitrosodimethylamine) Impurity Found in the Active Pharmaceutical Ingredient Manufactured by Solara Active Pharma Sciences Limited

January 08, 2020- Mylan Pharmaceuticals business is conducting a voluntary nationwide recall, to the consumer level, of three lots of Nizatidine Capsules, USP (including the 150mg and 300mg strengths). Nizatidine Capsules are being voluntarily recalled due to detected trace amounts of an impurity N-nitrosodimethylamine (NDMA) contained in the API Nizatidine, USP, manufactured by Solara Active Pharma Sciences Limited.

NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products and vegetables. NDMA has been classified as a probable human carcinogen (a substance that could cause cancer) according to the International Agency for Research on Cancer (IARC).

Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to using Nizatidine.

Consumers with questions regarding this recall can contact contact Stericycle at 888-628-0727 for the return of the recalled product. Normal business hours are Monday through Friday 8 a.m. to 5 p.m. EST.

Additional information may be found on the FDA recall website at: Mylan Initiates Voluntary Nationwide Recall of Three Lots of Nizatidine Capsules

January 2, 2020

Aurobindo Pharma USA, Inc. Issues Voluntary Nationwide Recall of Mirtazapine Tablets Lot Number 03119002A3 Due to Label Error on Declared Strength

 Aurobindo Pharma USA, Inc. is voluntarily recalling lot number 03119002A3 of Mirtazapine Tablets to the consumer level. The product is being recalled due to a label error on declared strength; bottles labeled as Mirtazapine 7.5 mg may contain 15 mg tablets.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Consumers with medical questions regarding this recall or to report an adverse event can contact Aurobindo Pharma USA, Inc. at: