FDA MedWatch - Metformin HCl Extended-Release Tablets USP, 750 mg by Viona Pharmaceuticals:

U.S. Food and Drug Administration sent this bulletin at 12/29/2021 08:58 PM EST

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MedWatch - The FDA Safety Information and Adverse Event Reporting Program

TOPIC: Metformin HCl Extended-Release Tablets USP, 750 mg by Viona Pharmaceuticals: Recall - Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity

AUDIENCE: Patient, Health Professional, Pharmacy

ISSUE: Viona Pharmaceuticals is recalling thirty three (33) lots of Metformin Hydrochloride Extended-Release Tablets USP, 750 mg due to an out of specification result observed for the said product, Lot number M008132, “N-nitrosodimethylamine (NDMA) (By GC-MS/MS)” test at 17 Month(s), 25°C/60%RH Long-term stability samples. This product was manufactured by Cadila Healthcare Limited, Ahmedabad, India for U.S. distribution by Viona Pharmaceuticals Inc.

Risk Statement: 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.

To date, neither Viona Pharmaceuticals Inc., nor Cadila Healthcare Limited have received any reports of adverse events related to this recall.

For more information about this recall, click on the red button "Read Recall" below.

BACKGROUND: The product being recalled is used as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus.

RECOMMENDATIONS:

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.
According to the FDA, it could be dangerous for patients with this serious condition to stop taking their metformin without first talking to their healthcare professionals. Please visit the agency’s website for more information at https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-and-press-announcements-ndma-metformin.
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.

Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report online.
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.

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