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Recall Observatory FDA recall evidence

Drug product

Losartan Potassium Tablets, USP, 25 mg, a) 90-count bottles (NDC # 33342-044-10), b) 1000-count bottles (NDC # 33342-044-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536

D-0832-2022

April 15, 2022

Class II

Product summary

Firm
Macleods Pharma Usa Inc
Event
Event 90037
Status
Terminated
Classification
Class II
Quantity
12,408/90 count bottles; 1670/1000 count bottles =2,786,720 tablets
Official record key
drug-enforcement:D-0832-2022

Official wording

Reason: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

Code information: Lot # BLH2002A, exp. date 11/2022 BLH2003B, exp. date 11/2022 BLH2004A, exp. date 11/2022

Distribution pattern: Product was distributed nationwide.

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    AZIDO Impurity
  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations