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Recall Observatory FDA recall evidence

Drug product

Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 90 count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, Himachal Pradesh, India. NDC 33342-0052-10

D-1040-2019

February 21, 2019

Class II

Product summary

Firm
Macleods Pharma Usa Inc
Event
Event 82147
Status
Terminated
Classification
Class II
Quantity
9695 bottles
Official record key
drug-enforcement:D-1040-2019

Official wording

Reason: CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.

Code information: Lot BLM715A, Jul-19

Distribution pattern: NJ, NY, FL

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    NDEA (N-Nitrosodimethylamine), a carcinogen impurity
  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviation