FDA-Drug2019-05-08Class II
Losartan Potassium Tablets USP 50 mg 50 tablets (5x10) Unit Dose Rx Only NDC 50268-517-15 Manufactured for: AvKARE Inc. Pulaski, TN 38478
AVKARE Inc.
Hazard
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 0.96 parts per million.
Sold states
Nationwide
Affected count
1438 cartons (71,900 tablets)
Manufactured in
615 N 1st St, N/A, Pulaski, TN, United States
Products
Losartan Potassium Tablets USP 50 mg 50 tablets (5x10) Unit Dose Rx Only NDC 50268-517-15 Manufactured for: AvKARE Inc. Pulaski, TN 38478
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1249-2019Don't want to check this manually?
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