Losartan Potassium Tab recalled over manufacturing violations

Recall date

April 30, 2019

Source

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

Official notice title

Preferred Pharmaceuticals, Inc recalls Losartan Potassium Tab. USP 50mg, a) 30 count bottle (NDC 68788-0048-03) and b) 90 count bottle (NDC 68788-0048-09), Rx…

Recall number

D-1281-2019

FDA classification

Class II

Brand / firm

Preferred Pharmaceuticals, Inc

Sold / distributed

CA, GA, IN. No DOD/VA 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 Tab. USP 50mg, a) 30 count bottle (NDC 68788-0048-03) and b) 90 count bottle (NDC 68788-0048-09), Rx only, Preferred Pharmaceuticals, Inc., Anaheim, CA, Mfg: Torrent Pharma Inc., Basking Ridge, NJ