Product: Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, 100 tablets per bottle, Rx Only, Manufactured by: Nostrum Laboratories, Inc., Kansas City, MO 64120, NDC: 29033-056-01
Reason for recall: CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Recall initiated: 20210104
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated