Losartan Potassium and Hydrochlorothiazide Tablets recalled over manufacturing violations

Recall date

March 5, 2019

Source

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

Official notice title

AVKARE Inc. recalls Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only Manuf…

Recall number

D-1046-2019

FDA classification

Class II

Brand / firm

AVKARE Inc.

Sold / distributed

Nationwide.

Why it was recalled

CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified

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 and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only Manufactured for: AvKARE Inc. Pulaski, TN 38478 --- NDC 50268-514-15