January 21, 2021
Nostrum Laboratories Inc. is recalling 6958 bottles of metformin hydrochloride extended-release tablets. According to the January 20, 2021, US Food and Drug Administration (FDA) Enforcement Report, the recall was prompted by the detection of an N-Nitrosodimethylamine (NDMA) impurity that tested above an acceptable level.
The recall affects 100-count metformin hydrochloride extended-release tablets, 750 mg (NDC 29033-056-01), from lot MET200501 (Exp. 7/22). The tablets were distributed throughout the United States.
Nostrum Laboratories voluntarily initiated the recall January 4, 2021. On January 14, 2021, the FDA designated the recall Class II, signaling use of the product could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.
Metformin is a prescription medication used to help control blood sugar levels in people with type 2 diabetes.