Drug product
QUETIAPINE Fumarate Tablets 25mg 100 Tablets (10x10) Blister card, Rx, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 68084-530-01
D-802-2013
Product summary
- Event
- Event 65683
- Status
- Terminated
- Classification
- Class II
- Quantity
- 19060 blister cards
- Official record key
drug-enforcement:D-802-2013
Official wording
Reason: Failed Dissolution Test Requirements: During analysis of long term stability studies at 3 months time point, an OOS was reported for Quetiapine Fumarate Tablets, 25 mg.
Code information: Lot 122600 Exp. 03/14
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Failed Dissolution Test Requirements: During analysis of long term stability studies at 3 months time point, an OOS was reported for Quetiapine Fumarate Tablets, 25 mg.