Drug product
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
D-0753-2021
Product summary
- Event
- Event 88482
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2880 bottles
- Official record key
drug-enforcement:D-0753-2021
Official wording
Reason: Presence of Foreign Tablets/Capsules; report of two Paroxetine tablets were found in the bottle
Code information: Z006279, exp 12/31/2022
Distribution pattern: Nationwide in the US
Derived failure modes
-
Foreign material or chemical contamination
Foreign Tablets