D-0263-2022 Class III Terminated
FDA drug recall D-0263-2022 was initiated by Aurobindo Pharma USA Inc. on November 15, 2021 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specifications The recall status is terminated (terminated August 23, 2023). Affected quantity: 7296 containers.
Recall Details
- Product Type
- Drugs
- Report Date
- December 1, 2021
- Initiation Date
- November 15, 2021
- Termination Date
- August 23, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7296 containers
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
Reason for Recall
Failed Impurities/Degradation Specifications
Distribution Pattern
Nationwide in the US
Code Information
Batch QG0619030-A, exp 11/2022