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Recall Observatory FDA recall evidence

Drug product

Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, a) 100 (NDC 62037-577-01) and b) 1000 (NDC 62037-577-10), Rx Only, Manufactured by: Watson Pharma Private Limited, Verna, Salcette Goa, Distributed by: Actavis Pharma, Inc., Parsippany, NJ

D-1332-2020

June 02, 2020

Class II

Product summary

Firm
Teva Pharmaceuticals USA
Event
Event 85797
Status
Terminated
Classification
Class II
Quantity
a) 15,329 bottles and b) 137 bottles
Official record key
drug-enforcement:D-1332-2020

Official wording

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

Code information: a) 1333338M, exp. date 08/2020, 1333339A, exp. date 08/2020; b) 1354471A, exp. date 02/2021

Distribution pattern: Product was distributed throughout the United States, including Puerto Rico.

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