Drug product
Actiq (oral transmucosal fentanyl citrate) 200 mcg, lozenge on a stick, a)Single Blister (NDC 63459-502-01), b) 30 count carton (NDC 63459-502-30), Rx only, Manufactured by: Cephalon, Inc., Salt Lake City, UT 84116
D-606-2013
Product summary
- Event
- Event 65298
- Status
- Terminated
- Classification
- Class II
- Quantity
- 316 cartons
- Official record key
drug-enforcement:D-606-2013
Official wording
Reason: Failed Dissolution Specification; during stability testing
Code information: Lot C88583, exp. 06/15
Distribution pattern: Product was distributed within the United States to FL, IL, MA, MO, MS, OH and TX. No government or foreign distribution.
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specification