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
Reported: December 25, 2024 Initiated: December 6, 2024 #D-0149-2025
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.
Details
- Recalling Firm
- Aurobindo Pharma USA Inc
- Distribution
- Nationwide in the USA
- Location
- East Windsor, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Aurobindo Pharma USA Inc.
Why was this product recalled? ▼
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso Nebivolol above acceptable intake (AI) limit.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 25, 2024. Severity: Moderate. Recall number: D-0149-2025.
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