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Recall Observatory FDA recall evidence

Drug product

LOSARTAN POTASSIUM TABLETS, USP 100 mg, Bulk, Rx only, For Further Manufacturing, Packing or Repackaging only, Manufactured by: Arrow Pharma (Malta) Ltd., Birzebbugia, Malta NDC 0591-3747-00

D-1102-2020

March 25, 2020

Class II

Product summary

Firm
Teva Pharmaceuticals USA
Event
Event 85306
Status
Ongoing
Classification
Class II
Quantity
N/A
Official record key
drug-enforcement:D-1102-2020

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: 1178533A, 1178534A, 1178535A, 1178536A, 1178537A, 1178538A, 1178539A, 1178540A, 1178541A, 1178542A, 1178543A, 1178544A, 1178545A, 1178546A exp 03/2020

Distribution pattern: Bulk product was distributed to one re-packager in California.

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