October 08, 2020
Sun Pharmaceutical Industries Inc. is voluntarily recalling 747 cartons of Riomet ER (metformin hydrochloride for extended-release oral suspension), citing detection of the probable human carcinogen N-Nitrosodimethylamine (NDMA) at levels above the acceptable daily intake limit. The recall is included in the October 7, 2020, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects cartons of Riomet ER, 500 mg per 5 mL (NDC 10631-019-17), from lot AB06381 (Exp. 10/21). Each carton contains one bottle of drug pellets, one bottle of diluent, and one dosing cup. When reconstituted, Riomet ER is packaged in a 16-ounce (473-mL) round bottle. The product was distributed throughout the United States.
Sun Pharmaceutical Industries initiated the recall September 23, 2020. On October 1, 2020, 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.