Drug product
Paroxetine Tablets USP, 30 mg, a) 30 count (NDC 68382-099-06), b) 500 count (NDC 68382-099-05), and c) 1000 count (NDC 68382-099-10) count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA, Inc., Pennington, NJ 08534
D-0101-2018
Product summary
- Event
- Event 78612
- Status
- Terminated
- Classification
- Class II
- Quantity
- 19812 bottles
- Official record key
drug-enforcement:D-0101-2018
Official wording
Reason: Presence of Foreign Tablets/Capsules: Risperidone Tablets were found in bottle of Paroxetine Tablets
Code information: a) Z701308, b) Z701309, c) Z701310 exp April 2019
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Foreign Tablets