February 12, 2021
Nostrum Laboratories Inc. has expanded its recall of metformin hydrochloride extended-release tablets to include an additional lot. The latest recall, also prompted by the detection of an N-Nitrosodimethylamine (NDMA) impurity that tested above an acceptable level, was included in the February 10, 2021, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects 100-count metformin hydrochloride extended-release tablets, 750 mg (NDC 29033-056-01), from lot MET200601 (Exp. 7/22). The tablets were distributed throughout the United States.
Nostrum Laboratories voluntarily initiated the recall January 25, 2021. On February 4, 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.
A previous recall by Nostrum Laboratories for metformin hydrochloride extended-release tablets was initiated January 4, 2021, and included in the January 20, 2021, FDA Enforcement Report.