Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 100 Tablets (10 x 10) unit dose ca...
FDA Recall #D-1360-2020 — Class II — June 12, 2020
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.
Recalling Firm
The Harvard Drug Group — Livonia, MI
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
1,906 Cartons
Distribution
Nationwide USA
Code Information
Lot T-02134, exp 09/2020
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated