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Class III: unlikely to cause harmTerminated

Aurobindo Pharma Carvedilol Tablets Recall

Carvedilol Tablets, USP, 6

Aurobindo Pharma USA Inc. · East Windsor, NJ

Risk level
Class III
Reported by FDA
Dec 1, 2021
Recall ID
D-0263-2022
Check your lot numberHow we source this data

Summary

Aurobindo Pharma recalled Carvedilol Tablets starting Nov 15, 2021. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-0263-2022 on Dec 1, 2021. Reason: Failed Impurities/Degradation Specifications. Status: Terminated.

Why it was recalled

Failed Impurities/Degradation Specifications

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

Lot numbers, UPCs & expiration codes

Batch QG0619030-A, exp 11/2022

Where it was sold

Nationwide in the US

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0263-2022
Classification
Class III
Status
Terminated
Recall initiated
Nov 15, 2021
FDA report date
Dec 1, 2021
Quantity
7296 containers
Recall type
Voluntary: Firm initiated
Recalling firm
Aurobindo Pharma USA Inc.

Original FDA data

Every field from FDA enforcement report D-0263-2022, exactly as published.

Show all FDA fields
City
East Windsor
State
NJ
Status
Terminated
Country
United States
Event ID
89045
Address
279 Princeton Hightstown Rd
Code information
Batch QG0619030-A, exp 11/2022
Postal code
08520-1401
Report date
Dec 1, 2021
Product type
Drugs
Recall number
D-0263-2022
Classification
Class III
Recalling firm
Aurobindo Pharma USA Inc.
Product quantity
7296 containers
Termination date
Aug 23, 2023
Reason for recall
Failed Impurities/Degradation Specifications
Voluntary / mandated
Voluntary: Firm initiated
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
Distribution pattern
Nationwide in the US
Recall initiation date
Nov 15, 2021
Initial firm notification
Letter
Center classification date
Dec 1, 2021

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0263-2022, published Dec 1, 2021. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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