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Recall Observatory FDA recall evidence

Drug product

Losartan Potassium Tablets, USP, 100 mg, a) 30-count bottles (NDC # 33342-046-07), b) 90-count bottles (NDC # 33342-046-10), c) 1000-count bottles (NDC # 33342-046-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536

D-0834-2022

April 15, 2022

Class II

Product summary

Firm
Macleods Pharma Usa Inc
Event
Event 90037
Status
Terminated
Classification
Class II
Quantity
3288/30 count bottles; 23,904/90 count bottles; 3364/1000 count bottles = 5,614,000 tablets
Official record key
drug-enforcement:D-0834-2022

Official wording

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

Code information: Lot # BLI2107B, exp. date 06/2023 BLI2101A, exp. date 12/2022 BLI2103A, exp. date 12/2022 BLI2105A, exp. date 05/2023

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