Losartan Pot/HCTZ 50/12 recalled over manufacturing violations

Recall date

March 12, 2019

Source

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

Official notice title

Direct Rx recalls Losartan Pot/HCTZ 50/12.5 mg 90 Tabs Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg For: Torrent Phar…

Recall number

D-0032-2021

FDA classification

Class II

Brand / firm

Direct Rx

Sold / distributed

FL

Why it was recalled

CGMP deviation: Trace amounts of impurity detected to be N-Methylnitrosobutyric acid (NMBA) in the API.

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 Pot/HCTZ 50/12.5 mg 90 Tabs Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg For: Torrent Pharma, Inc. Basking Ridge, NJ 07920 NDC 61919-040-90