Drug 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
D-0149-2025
Product summary
- Event
- Event 95934
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
drug-enforcement:D-0149-2025
Official wording
Reason: CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso Nebivolol above acceptable intake (AI) limit.
Code information: Lot #: NB0224001A and NB0224001B, Exp. Date 04/2027
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Foreign material or chemical contamination
Nitrosamine Drug Substance Related Impurity
-
Manufacturing or process control
CGMP Deviations