D-0149-2025 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- December 25, 2024
- Initiation Date
- December 6, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
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.
Distribution Pattern
Nationwide in the USA
Code Information
Lot #: NB0224001A and NB0224001B, Exp. Date 04/2027