Losartan Potassium USP recalled over manufacturing violations

Recall date

March 8, 2019

Source

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

Official notice title

PD-Rx Pharmaceuticals, Inc. recalls Losartan Potassium USP, 50 mg, RX Only, Pkg By PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 60 Tablets…

Recall number

D-0341-2021

FDA classification

Class II

Brand / firm

PD-Rx Pharmaceuticals, Inc.

Sold / distributed

AK, AZ, CA, CO, FL, KY, MA, MI, MN, NC, OH, OR, WI, WY

Why it was recalled

CGMP deviation: Product found to contain trace amounts of NMBA

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 USP, 50 mg, RX Only, Pkg By PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 60 Tablets NDC: 43063-854-60; b) 90 Tablets NDC: 43063-0854-90