Nebivolol Tablet
FDA Recall NDC 59651-140
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Nebivolol (NDC 59651-140). A significant event, classified as Class II, was initiated on Dec 06, 2024 by Aurobindo Pharma Limited. The reported reason for this action was: "CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso Nebivolol above acceptable intake (AI) limit."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso Nebivolol above acceptable intake (AI) limit.
Dec 06, 2024
Dec 25, 2024
N/A
Recall Profile & Regulatory Data
Event ID
95934
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Aurobindo Pharma USA Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
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
Batch or Lot Expiration Information
Lot# : NB0224001A and NB0224001B, Exp. Date 04/2027
Affected Packages Involved in this Recall
59651-137-30Product
59651-137-90Product
59651-138-30Product
59651-138-90Product
59651-139-30Product
59651-139-90Product
59651-140-30Product
59651-140-90Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
