FDARecalled Dec 25, 2024 · #D-0149-2025
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
Hazard
Class II — temporary health risk
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CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso Nebivolol above acceptable intake (AI) limit. Classification: Class II Distribution: Nationwide in the USA
Product details
- Product
- 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
- Type
- Drugs
- Manufacturer
- Aurobindo Pharma USA Inc
- Model numbers
- NB0224001A
- UPCs
- —