Drug product

LOSARTAN POTASSIUM TABLETS, USP 50 mg, Bulk, Rx only, For Further Manufacturing, Packing or Repackaging only, Manufactured by: Arrow Pharma (Malta) Ltd., Birzebbugia, Malta NDC 0591-3746-00

D-1101-2020

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-1101-2020

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: Lots 1195625A, 1195624A, 1195623A, exp. date 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