Drug recall D-0149-2025
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
Reason for recall
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso Nebivolol above acceptable intake (AI) limit.
Lots and codes
Lot #: NB0224001A and NB0224001B, Exp. Date 04/2027
Recall details
- Recalling firm
- Aurobindo Pharma USA Inc, East Windsor, NJ
- Distribution
- Nationwide in the USA
- Type
- Voluntary: Firm initiated
- Recall initiated
- December 6, 2024
Related products
- Nebivolol – drug information
- NDC 59651-140 Nebivolol · Nebivolol Hydrochloride 20 mg/1 · Aurobindo Pharma Limited
- NDC 59651-139 Nebivolol · Nebivolol Hydrochloride 10 mg/1 · Aurobindo Pharma Limited
- NDC 59651-137 Nebivolol · Nebivolol Hydrochloride 2.5 mg/1 · Aurobindo Pharma Limited
- NDC 59651-138 Nebivolol · Nebivolol Hydrochloride 5 mg/1 · Aurobindo Pharma Limited