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FDAJune 12, 2020drug

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 recall recorded by the U.S. Food & Drug Administration.

The hazard

CGMP Deviation: Potential presence of Nitrosodimethylamine (NDMA) Impurity above the established levels.

What to do

FDA enforcement status: Terminated

Brands named

harvard drugharvard

UPCs

00904579461

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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