FDA-Drug2019-07-17Class II
Losartan Potassium Tablets, USP 50 mg 90 tablets Rx Only Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi, Himachal Pradesh, INDIA NDC 33342-045-10
Macleods Pharma Usa Inc
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
Affected count
47520 bottles (4,276,800 tablets)
Manufactured in
666 Plainsboro Rd Bldg 200 Ste 230, Plainsboro, NJ, United States
Products
Losartan Potassium Tablets, USP 50 mg 90 tablets Rx Only Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi, Himachal Pradesh, INDIA NDC 33342-045-10
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1457-2019Don't want to check this manually?
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