Recalls / Class II
Class IID-606-2013
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
- Affected lot / code info
- Lot C88583, exp. 06/15
Why it was recalled
Failed Dissolution Specification; during stability testing
Recalling firm
- Firm
- Teva Pharmaceuticals USA, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 650 Cathill Rd, Sellersville, Pennsylvania 18960-1512
Distribution
- Quantity
- 316 cartons
- Distribution pattern
- Product was distributed within the United States to FL, IL, MA, MO, MS, OH and TX. No government or foreign distribution.
Timeline
- Recall initiated
- 2013-05-28
- FDA classified
- 2013-06-19
- Posted by FDA
- 2013-06-26
- Terminated
- 2014-07-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-606-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.