Losartan Potassium 100 mg recalled over manufacturing violations

Recall date

April 30, 2019

Source

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

Official notice title

Direct Rx recalls Losartan Potassium 100 mg, 30 Tabs bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC 6…

Recall number

D-0018-2021

FDA classification

Class II

Brand / firm

Direct Rx

Sold / distributed

GA

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 per 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 100 mg, 30 Tabs bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC 61919-952-30