Product: Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 100 Tablets (10 x 10) unit dose cartons, Rx only, Manufactured by: Apotex, Inc., Toronto, Ontario, Canada, Manufactured for: Apotex Corp. Weston, FL, Distributed by: Major Pharmaceuticals, Livonia, MI 48152  NDC 00904-5794-61
Reason for recall: CGMP Deviation:  Potential presence of Nitrosodimethylamine (NDMA) Impurity above the established levels.
Recall initiated: 20200612
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated