FDA-Drug2019-07-17Class II
LOSARTAN POTASSIUM 50 mg TABLET BULK 90 count bottles and 1000 count bottles, NDC 00591-3746-00
Teva Pharmaceuticals USA
Hazard
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Sold states
Nationwide by 4 major distributors.
Affected count
2,924,000 tablets
Manufactured in
400 Interpace Pkwy, Parsippany, NJ, United States
Products
LOSARTAN POTASSIUM 50 mg TABLET BULK 90 count bottles and 1000 count bottles, NDC 00591-3746-00
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1455-2019Don't want to check this manually?
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