Home / Recalls / The Harvard Drug Group / D-1360-2020

D-1360-2020 Class II Terminated

Recalled by The Harvard Drug Group — Livonia, MI

Recall Details

Product Type
Drugs
Report Date
July 8, 2020
Initiation Date
June 12, 2020
Termination Date
September 24, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1,906 Cartons

Product Description

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.

Distribution Pattern

Nationwide USA

Code Information

Lot T-02134, exp 09/2020

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