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Recall Observatory FDA recall evidence

Drug 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

D-1360-2020

June 12, 2020

Class II

Product summary

Firm
The Harvard Drug Group
Event
Event 85861
Status
Terminated
Classification
Class II
Quantity
1,906 Cartons
Official record key
drug-enforcement:D-1360-2020

Official wording

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

Code information: Lot T-02134, exp 09/2020

Distribution pattern: Nationwide USA

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    NDMA) Impurity
  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviation