FDAHealthDecember 6, 2024
Aurobindo Pharma USA Inc — 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
⚠️ CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso Nebivolol above acceptable intake (AI) limit.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- December 6, 2024
Nationwide in the USA
What's affected?
- 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
- Brand
- NEBIVOLOL
- UPC
- 0359651137307
- Lot code
- NB0224001A
Additional details
Lot #: NB0224001A and NB0224001B, Exp. Date 04/2027
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated
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