FDA-Drug2024-12-25Class II
Nebivolol Tablets, 2.5. mg, 30-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520. NDC: 59651-137-30
Aurobindo Pharma USA Inc
Hazard
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso Nebivolol above acceptable intake (AI) limit.
Sold states
Nationwide in the USA
Manufactured in
279 Princeton Hightstown Rd, East Windsor, NJ, United States
Products
Nebivolol Tablets, 2.5. mg, 30-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520. NDC: 59651-137-30
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0149-2025Don't want to check this manually?
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