Diabetes Tablet Recalled for NDMA

Viona Pharmaceuticals Inc is voluntarily recalling two lots of metformin hydrochloride extended-release tablets after a US Food and Drug Administration (FDA) analysis detected N-Nitrosodimethylamine (NDMA) levels above acceptable limits, according to the June 30, 2021, FDA Enforcement Report.

The recall affects 21,240 bottles of 100-count metformin hydrochloride extended-release tablets, 750 mg (NDC 72578-036-01), from lots M1915601 and M915602 (Exp. 10/21). The tablets were manufactured by Cadila Healthcare Ltd, Ahmedabad, India, and distributed throughout the United States by Viona Pharmaceuticals Inc, Cranford, NJ.

Viona Pharmaceuticals initiated the recall June 1, 2021. On June 24, 2021, the FDA designated the recall Class II. Drugs affected by Class II recalls may cause temporary or medically reversible adverse health consequences if used. While remote, a possibility of serious harm also exists.

Metformin is a prescription medication used to help control blood sugar levels in people with type 2 diabetes.