Losartan Potassium Tablets recalled over manufacturing violations

Recall date

April 3, 2020

Source

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

Official notice title

Golden State Medical Supply Inc. recalls Losartan Potassium Tablets, USP, 25 mg, Rx only, a) 30 ct. (NDC 60429-316-30) b) 90ct. (NDC 60429-316-90) c) 1,000 ct.…

Recall number

D-1238-2020

FDA classification

Class II

Brand / firm

Golden State Medical Supply Inc.

Sold / distributed

Nationwide

Why it was recalled

CGMP Deviations: Impurity for N-nitroso-N-methyl-4-aminobutryric Acid (NBMA) detected in active 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 Tablets, USP, 25 mg, Rx only, a) 30 ct. (NDC 60429-316-30) b) 90ct. (NDC 60429-316-90) c) 1,000 ct. (60429-316-10) bottles, GSMS Incorporated, Manufactured by Arrow Pharm (Malta) Ltd., Packaged by GSMS Incorporated, Camarillo, CA 93012, USA