5. Metformin Hydrochloride Extended-Release Tablets from Viona Pharmaceuticals Inc.
Viona Pharmaceuticals Inc., is voluntarily recalling two lots of Metformin Hydrochloride Extended-Release Tablets, USP 750 mg. The two lots of Metformin Hydrochloride Extended-Release 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 based on results from laboratory tests. NDMA is also known as an environmental contaminant and found in water and foods, including meats, dairy products, and vegetables. The product is used as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus. Patients who have received impacted lots of Metformin Hydrochloride Extended-Release Tablets, USP 750 mg are advised to continue taking their regular medications and contact their physician for advice regarding an alternative treatment.
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