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Recall Observatory FDA recall evidence

Drug product

Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles, Rx Only Manufactured by: Apotex, Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326 NDC 60505-0260-1

D-1303-2020

May 27, 2020

Class II

Product summary

Firm
Apotex Inc.
Event
Event 85772
Status
Completed
Classification
Class II
Quantity
305,963 bottles
Official record key
drug-enforcement:D-1303-2020

Official wording

Reason: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above acceptable intake levels

Code information: All lots remaining within expiry

Distribution pattern: Nationwide.

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 Deviations