Metformin HCl Extended-Release Tabs by Viona Pharm: Recalled

Viona Pharmaceuticals has recalled two lots of Metformin Hydrochloride Extended-Release Tablets - USP 750 mg as it contains 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.

As of this writing, Viona Pharmaceuticals, nor Cadila Healthcare Limited have not received reports of any adverse events related to this recall.

For more detailed information about the recall, click here.

Product Description

Metformin Hydrochloride Extended-Release Tablets, USP 750 mg
NDC No.: 72578-036-01
Batch No.: M915601
Exp. Date: Oct-2021

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

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 the 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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