AVKARE Inc. recalls Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only Manufac
Recalled March 27, 2019 · FDA recall D-1045-2019 · AVKARE
Hazard
CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified · FDA Class II
Units
N/A
Sold at
Nationwide.
Description
CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified
Product
Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only Manufactured for: AvKARE Inc. Pulaski, TN 38478 --- NDC 50268-513-15
Manufacturer(s)
AVKARE Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →