FDA-Drug2020-07-08Class II
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
The Harvard Drug Group
Hazard
CGMP Deviation: Potential presence of Nitrosodimethylamine (NDMA) Impurity above the established levels.
Sold states
Nationwide USA
Affected count
1,906 Cartons
Manufactured in
17177 N Laurel Park Dr Ste 233, N/A, Livonia, MI, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1360-2020Don't want to check this manually?
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