United States
Company name: Viona Pharmaceuticals Inc.
Brand name: Viona Pharmaceuticals Inc.
Product recalled: Metformin Hydrochloride Extended-Release Tablets
Reason of the recall: Contains Nitrosodimethylamine (NDMA) impurities
FDA Recall date: June 11, 2021
Recall details: Viona Pharmaceuticals Inc., is voluntarily recalling 2 (two) lots of Metformin Hydrochloride Extended-Release Tablets, USP 750 mg to the retail level. The 2 (two) lots of Metformin Hydrochloride Extended-Release Tablets, USP 750 mg 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.
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. 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
www.fda.gov To date, neither Viona Pharmaceuticals Inc., nor Cadila Healthcare Limited have received any reports of adverse events related to this recall.
The product is used as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus and is packaged in HDPE bottles of 100 tablets, under NDC 72578-036-01. The affected Metformin Hydrochloride Extended-Release Tablets, USP 750 mg are listed in the below table. The product can be identified as white to off-white, capsule shaped, uncoated tablets, debossed with "Z", "C" on one side and "20" on the other side. Metformin Hydrochloride Extended-Release Tablets, USP 750 mg was distributed Nationwide to Distributors.
- Metformin Hydrochloride Extended-Release Tablets, USP 750 mg. NDC No: 72578-036-01. Batch No: M915601. Exp. Date: Oct-2021.
Check the full recall details on
www.fda.gov
Source: FDA
