Status
Terminated
Drug Enforcement D-606-2013
Failed Dissolution Specification; during stability testing
Classification
Class II
Report Date
June 26, 2013
Termination Date
July 23, 2014
Product Information
- Product description
- 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
- Product quantity
- 316 cartons
- Reason for recall
- Failed Dissolution Specification; during stability testing
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Product was distributed within the United States to FL, IL, MA, MO, MS, OH and TX. No government or foreign distribution.
Location & Firm
- Recalling firm
- Teva Pharmaceuticals USA, Inc.
- Address
-
650 Cathill Rd
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-606-2013
- Event ID
- 65298
- Recall initiation date
- May 28, 2013
- Center classification date
- June 19, 2013
- Code info
- Lot C88583, exp. 06/15
- More code info
- —