Drug product
risperiDONE ORALLY DISINTEGRATING TABLETS, 2 mg, 30 Ct Bottles, Rx Only. Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India. Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC: 68382-156-06.
D-0725-2016
Product summary
- Event
- Event 73221
- Status
- Terminated
- Classification
- Class III
- Quantity
- 9504 Bottles
- Official record key
drug-enforcement:D-0725-2016
Official wording
Reason: Failed Impurities/Degradation Specifications: Out of specification for a known degradant.
Code information: Lot #: MP4967, Expiry: 04/2016.
Distribution pattern: US Nationwide including Puerto Rico
Derived failure modes
-
Potency or specification failure
Out of specification