Carvedilol Tablets, USP, 6.25 mg, 500 Tablets bottle, Rx Only, Distributed by: Aurobindo Pharma U...
FDA Recall #D-0263-2022 — Class III — November 15, 2021
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
Recalling Firm
Aurobindo Pharma USA Inc. — East Windsor, NJ
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
7296 containers
Distribution
Nationwide in the US
Code Information
Batch QG0619030-A, exp 11/2022
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated