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Recall Observatory FDA recall evidence

Drug product

Nizatidine Capsules, USP 150 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5150-91.

D-0791-2020

January 07, 2020

Class II

Product summary

Firm
Mylan Pharmaceuticals Inc.
Event
Event 84607
Status
Terminated
Classification
Class II
Quantity
31,736 bottles of 60 capsules
Official record key
drug-enforcement:D-0791-2020

Official wording

Reason: CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the API Nizatidine.

Code information: Lot Number: 3086746, exp. date May 2020

Distribution pattern: Product was distributed to wholesalers, distributors , retail pharmacies, charitable organizations and mail order pharmacies throughout the United States and the product may have been further distributed.

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    impurity, N-nitrosodimethylamine (NDMA
  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations