November 25, 2020
Preferred Pharmaceuticals Inc. is recalling two lots of metformin hydrochloride extended-release tablets due to the detection of an N-Nitrosodimethylamine (NDMA) impurity that tested above an acceptable level, according to the November 25, 2020, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects 100-count metformin hydrochloride extended-release tablets, 500 mg (NDC 68788-6932-1), from lots E0620F (Exp. 12/31/21) and G2020M (Exp. 4/30/22). The tablets were manufactured by Time-Cap Labs and distributed to two physician offices in Florida.
Preferred Pharmaceuticals voluntarily initiated the recall November 1, 2020. On November 14, 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. Although 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.