Carvedilol Tablet, Film Coated
FDA Recall NDC 65862-142
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 Carvedilol (NDC 65862-142). A significant event, classified as Class III, was initiated on Nov 15, 2021 by Aurobindo Pharma Limited. The reported reason for this action was: "Failed Impurities/Degradation Specifications"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
November 2021 Class III Recall: Failed Impurities/Degradation Specifications
Recall Number
Class III Terminated
Failed Impurities/Degradation Specifications
Nov 15, 2021
Dec 01, 2021
7296 containers
Recall Profile & Regulatory Data
Event ID
89045
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Aurobindo Pharma USA Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the US
Termination Date
Aug 23, 2023
Product Description
Carvedilol Tablets, USP, 6.25 mg, 500 Tablets bottle, Rx Only, Distributed by: Aurobindo Pharma USA Inc., 279 Princeton-Hightstown Road, East Windsor, NJ, 08520, Made in India, NDC 65862-143-05
Batch or Lot Expiration Information
Batch# Batch QG0619030-A, exp 11/2022
Affected Packages Involved in this Recall
65862-142-01Product
65862-142-05Product
65862-142-99Product
65862-143-01Product
65862-143-05Product
65862-143-99Product
65862-144-01Product
65862-144-05Product
65862-144-99Product
65862-145-01Product
65862-145-05Product
65862-145-99Product
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.
