Drug product
Paroxetine tablets USP, 30mg, 30-count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA, Inc., Pennington, NJ 08534, NDC 68382-099-06, UPC 3 6838209906 8
D-1137-2017
Product summary
- Event
- Event 77963
- Status
- Terminated
- Classification
- Class II
- Quantity
- 44800 bottles
- Official record key
drug-enforcement:D-1137-2017
Official wording
Reason: Presence of Foreign tablets/capsules: risperidone Tablets were found in bottle of paroxetine Tablets
Code information: Lot #: Z701133, Exp 03/19
Distribution pattern: Nationwide within United States
Derived failure modes
-
Foreign material or chemical contamination
Foreign tablets