Drug product
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
D-1242-2019
Product summary
- Event
- Event 82682
- Status
- Terminated
- Classification
- Class III
- Quantity
- 7668 bottles
- Official record key
drug-enforcement:D-1242-2019
Official wording
Reason: 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.
Code information: Lot #: Z803518, Exp 08/2020
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Foreign material or chemical contamination
Foreign Tablets