Drug product
PALIPERIDONE EXTENDED-RELEASE TABLETS, 9 mg, 100 Tablets per carton (10 x 10 blister packs), Rx only, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15, Dadra-396 191, India. Distributed by: MAJOR PHARMACEUTICALS, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152. NDC: 0904-6937-61
D-0649-2022
Product summary
- Event
- Event 89681
- Status
- Terminated
- Classification
- Class II
- Quantity
- 174 cartons
- Official record key
drug-enforcement:D-0649-2022
Official wording
Reason: Failed Dissolution Specifications
Code information: Lot #: N00522, Exp. Date 09/2022; N00618, Exp. Date 11/2022
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications