Voluntary safety recall of contaminated metformin products
Viona Pharmaceuticals, Inc., is voluntarily recalling 33 lots of metformin hydrochloride extended-release tablets, USP 750 mg, due to presence of N-Nitrosodimethylamine, or NDMA, according to a company statement.
Levels of NDMA out of the specification range were observed for 25°C/60%RH long-term stability samples of lot number M008132 tested at 17 months, according to the statement posted on the FDA website.
NDMA is classified as a probable human carcinogen based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products and vegetables. No adverse events related to the product have been received, according to the company.
The recalled lots were manufactured by Cadila Healthcare Limited, Ahmedabad, India, for Viona Pharmaceuticals and were distributed nationwide in the U.S. Recalled lot numbers are listed on the FDA website. The company said it is notifying customers by email and FedEx Overnight to arrange for return of the recalled tablets.
As Healio previously reported, the FDA announced in December 2019 that non-U.S. countries had reported that NDMA might be present in metformin products, prompting an agency investigation. From May to November 2020, the FDA asked at least six companies to voluntarily recall several lots of extended-release metformin after agency lab testing revealed unacceptable levels of NDMA.
Consumers with medical questions regarding the Viona Pharmaceuticals recall can contact the company by phone at: 888-304-5011.
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