PlainRecalls
FDA Drug Low Class III Terminated

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

Reported: December 1, 2021 Initiated: November 15, 2021 #D-0263-2022

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

Details

Recalling Firm
Aurobindo Pharma USA Inc.
Units Affected
7296 containers
Distribution
Nationwide in the US
Location
East Windsor, NJ

Frequently Asked Questions

What product was recalled?
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. Recalled by Aurobindo Pharma USA Inc.. Units affected: 7296 containers.
Why was this product recalled?
Failed Impurities/Degradation Specifications
Which agency issued this recall?
This recall was issued by the FDA Drug on December 1, 2021. Severity: Low. Recall number: D-0263-2022.