The Harvard Drug Group recalls Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 100 Tablets (10 x 10) unit dose cartons, Rx only, Manufac
Recalled July 8, 2020 · FDA recall D-1360-2020 · The Harvard Drug Group
Hazard
CGMP Deviation: Potential presence of Nitrosodimethylamine (NDMA) Impurity above the established levels. · FDA Class II
Units
1,906 Cartons
Sold at
Nationwide USA
Description
CGMP Deviation: Potential presence of Nitrosodimethylamine (NDMA) Impurity above the established levels.
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
Manufacturer(s)
The Harvard Drug Group
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →