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Recall Observatory FDA recall evidence

Drug product

amneal Metformin Hydrochloride Extended-Release Tablets, 500 mg USP, 500 tablets bottles, Rx only, Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 53746-0178-05

D-1351-2020

May 29, 2020

Class II

Product summary

Firm
Amneal Pharmaceuticals of New York, LLC
Event
Event 85781
Status
Ongoing
Classification
Class II
Quantity
N/A
Official record key
drug-enforcement:D-1351-2020

Official wording

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

Code information: HF06618A 6/30/2020 HF06718A 6/30/2020

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