FDA-Drug2020-04-15Class II
LOSARTAN POTASSIUM TABLETS, USP 50 mg, Bulk, Rx only, For Further Manufacturing, Packing or Repackaging only, Manufactured by: Arrow Pharma (Malta) Ltd., Birzebbugia, Malta NDC 0591-3746-00
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
Bulk product was distributed to one re-packager in California.
Affected count
N/A
Manufactured in
400 Interpace Pkwy, N/A, Parsippany, NJ, United States
Products
LOSARTAN POTASSIUM TABLETS, USP 50 mg, Bulk, Rx only, For Further Manufacturing, Packing or Repackaging only, Manufactured by: Arrow Pharma (Malta) Ltd., Birzebbugia, Malta NDC 0591-3746-00
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1101-2020Don't want to check this manually?
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