Drug Enforcement D-0149-2025

CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso Nebivolol above acceptable intake (AI) limit.

Status

Ongoing

Classification

Class II

Report Date

December 25, 2024

Termination Date

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Product Information

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
Product quantity
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Reason for recall
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso Nebivolol above acceptable intake (AI) limit.
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
Aurobindo Pharma USA Inc
Address
279 Princeton Hightstown Rd

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-0149-2025
Event ID
95934
Recall initiation date
December 6, 2024
Center classification date
December 16, 2024
Code info
Lot #: NB0224001A and NB0224001B, Exp. Date 04/2027
More code info
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