D-1242-2019 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- May 1, 2019
- Initiation Date
- April 22, 2019
- Termination Date
- January 14, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7668 bottles
Product Description
Carvedilol Tablets, USP, 3.125 mg, 500-count bottle, Rx Only, Manufactured by: Cadila Healthcare Ltd., India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534; NDC 68382-092-05
Reason for Recall
Presence of Foreign Tablets/Capsules: Customer complaint for a small, solid, light yellow substance, identified as a fragmented tablet of another drug product, found mixed with tablets in a bottle of Carvedilol tablets 3.125mg.
Distribution Pattern
Nationwide in the USA
Code Information
Lot #: Z803518, Exp 08/2020