FDA-Drug2019-03-27Class II
Losartan Potassium Tablets USP, 25 mg, Rx only, a) 90 count (NDC 31722-700-90), b) 500 count (NDC 31722-700-05) and c) 1000 count (NDC 31722-700-05) bottles, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 By: Hetero Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar -509 301, India
Camber Pharmaceuticals Inc
Hazard
CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient
Sold states
Nationwide
Affected count
351,732 bottles
Manufactured in
1031 Centennial Ave, N/A, Piscataway, NJ, United States
Products
Losartan Potassium Tablets USP, 25 mg, Rx only, a) 90 count (NDC 31722-700-90), b) 500 count (NDC 31722-700-05) and c) 1000 count (NDC 31722-700-05) bottles, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 By: Hetero Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar -509 301, India
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1041-2019Don't want to check this manually?
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