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Metformin Extended-Release Tablets, USP 750 mg, Recalled

On January 07, 2022, Viona Pharmaceuticals announced it is voluntarily recalling 23 lots of Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, due to the presence of N-nitrosodimethylamine (NDMA), a cancer-causing impurity. 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 based on results from laboratory tests. 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 doctor for advice regarding an alternative treatment.

References:

  1. Center for Drug Evaluation and Research. (2022, January 7). 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. U.S. Food and Drug Administration. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/viona-pharmaceuticals-inc-issues-voluntary-nationwide-recall-metformin-hcl-extended-release-tablets-0?utm_medium=email&utm_source=govdelivery
Published on: January 17, 2022, 15:09 p.m. ET
Last updated on: January 17, 2022, 08:50 a.m. ET