FDA-Drug2019-03-27Class II
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
AVKARE Inc.
Hazard
CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified
Sold states
Nationwide.
Affected count
N/A
Manufactured in
615 N 1st St, N/A, Pulaski, TN, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1045-2019Don't want to check this manually?
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