LOSARTAN POTASSIUM 100 mg TABLET BULK bottles recalled over manufacturing violations

Recall date

June 6, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Teva Pharmaceuticals USA recalls LOSARTAN POTASSIUM 100 mg TABLET BULK 90 count bottles, NDC 00591-3747-00

Recall number

D-1456-2019

FDA classification

Class II

Brand / firm

Teva Pharmaceuticals USA

Sold / distributed

Nationwide by 4 major distributors.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

LOSARTAN POTASSIUM 100 mg TABLET BULK 90 count bottles, NDC 00591-3747-00