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Recall Observatory FDA recall evidence

Drug product

Metformin Hydrochloride Extended-release Tablets USP, 500 mg, 60 count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD Manufactured by: Lupin Limited Goa INDIA (NDC 68180-336-07)

D-1334-2020

June 11, 2020

Class II

Product summary

Firm
Lupin Pharmaceuticals Inc.
Event
Event 85840
Status
Terminated
Classification
Class II
Quantity
6,540 bottles
Official record key
drug-enforcement:D-1334-2020

Official wording

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

Code information: Batch # G901203, exp. date 12/2020

Distribution pattern: Product was distributed throughout the United States.

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