Losartan Potassium Tablets USP 100 mg bottle Rx only GSMS Incorporated recalled over manufacturing violations

Recall date

May 1, 2019

Source

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

Official notice title

Golden State Medical Supply Inc. recalls Losartan Potassium Tablets USP 100 mg 1000 count bottle NDC 60429-318-10 Rx only GSMS Incorporated

Recall number

D-1286-2019

FDA classification

Class II

Brand / firm

Golden State Medical Supply Inc.

Sold / distributed

IL, MI, MN, PA, TN, TX. Two (2) US government and one (1) Veterans Affairs accounts. No foreign accounts.

Why it was recalled

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer

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 100 mg 1000 count bottle NDC 60429-318-10 Rx only GSMS Incorporated