Class II
Terminated
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
- Company
- The Harvard Drug Group
- Recall Initiated
- June 12, 2020
- Posted
- July 8, 2020
- Recall Number
- D-1360-2020
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 1,906 Cartons
- Firm Location
- Livonia, MI, United States
Reason for Recall
CGMP Deviation: Potential presence of Nitrosodimethylamine (NDMA) Impurity above the established levels.
Distribution
Nationwide USA
Lot / Code Info
Lot T-02134, exp 09/2020
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