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Recall Observatory FDA recall evidence

Drug product

Losartan Potassium andHydrochlorothiazide Tablets 100 mg/25 mg 90 tablets, USP Rx Only, Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi, Himachal Pradesh, INDIA NDC 33342-052-10

D-1461-2019

June 20, 2019

Class II

Product summary

Firm
Macleods Pharma Usa Inc
Event
Event 83151
Status
Terminated
Classification
Class II
Quantity
145162 bottles (13,064,580 tablets)
Official record key
drug-enforcement:D-1461-2019

Official wording

Reason: CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.

Code information: BLM716A Jul-19 BLM717A Jul-19 BLM719A Aug-19 BLM720A Aug-19 BLM721A Sep-19 BLM722A Sep-19 BLM723A Oct-19 BLM724A Oct-19 BLM725A Oct-19 BLM726A Nov-19 BLM802A Dec-19 BLM803A Dec-19 BLM825A Sep-21 BLM826A Sep-21 BLM827A Sep-21

Distribution pattern: Nationwide

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA
  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations