November 06, 2020
RemedyRepack Inc. is recalling 79 metformin hydrochloride blister cards due to the detection of an N-Nitrosodimethylamine (NDMA) impurity in the drug that tested above an acceptable level, according to the November 4, 2020, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects 30-count blister cards of metformin hydrochloride extended-release tablets, 750 mg (NDC 70518-2480-00), from lots J0423350-121219 (Exp. 12/31/20), J0434828-020320 (Exp. 2/28/21), J0442511-031220 (Exp. 3/31/21), J0448429-040920 (Exp. 4/30/21), J0472499-081020 (Exp. 8/31/21), and J0472532-081020 (Exp. 8/31/21). The affected product was repackaged by RemedyRepack and distributed to a single customer in Pennsylvania.
RemedyRepack voluntarily initiated the recall October 11, 2020. On October 26, 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.