D-0753-2021 Class II Terminated

Recalled by Zydus Pharmaceuticals (USA) Inc — Pennington, NJ

Recall Details

Product Type
Drugs
Report Date
August 25, 2021
Initiation Date
August 13, 2021
Termination Date
April 3, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2880 bottles

Product Description

Carvedilol Tablets, USP 25 mg, 500 Tablets bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 0853, NDC 68382-095-05

Reason for Recall

Presence of Foreign Tablets/Capsules; report of two Paroxetine tablets were found in the bottle

Distribution Pattern

Nationwide in the US

Code Information

Z006279, exp 12/31/2022