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Recall Observatory FDA recall evidence

Drug product

Nizatidine Capsules, USP 300 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5300-93.

D-0792-2020

January 07, 2020

Class II

Product summary

Firm
Mylan Pharmaceuticals Inc.
Event
Event 84607
Status
Terminated
Classification
Class II
Quantity
16,944 bottles of 30 capsules
Official record key
drug-enforcement:D-0792-2020

Official wording

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

Code information: Lot # 3082876, exp. date January 2020 Lot # 3082877, exp. date January 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