Class II
Ongoing
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
This recall is currently active, issued December 25, 2024. It was issued by Aurobindo Pharma Usa Inc..
- Company
- Aurobindo Pharma Usa Inc.
- Recall Initiated
- December 6, 2024
- Posted
- December 25, 2024
- Recall Number
- D-0149-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Firm Location
- East Windsor, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso Nebivolol above acceptable intake (AI) limit.
Distribution
Nationwide in the USA
Lot / Code Info
Lot #: NB0224001A and NB0224001B, Exp. Date 04/2027
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