Teva Pharmaceuticals USA recalls LOSARTAN POTASSIUM TABLETS, USP 100 mg, Bulk, Rx only, For Further Manufacturing, Packing or Repackaging only, Manufactu

Recalled April 15, 2020 · FDA recall D-1102-2020 · Teva Pharmaceuticals USA

Hazard

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

Units

N/A

Sold at

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

Description

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

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

Manufacturer(s)

Teva Pharmaceuticals USA

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →