FDA recall D-606-2013

Teva Pharmaceuticals USA, Inc. · Class II · 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

Reason for recall

Failed Dissolution Specification; during stability testing

Distribution

Product was distributed within the United States to FL, IL, MA, MO, MS, OH and TX. No government or foreign distribution.

Key facts

Status: Terminated
Initiation date: 2013-05-28
Report date: 2013-06-26
Termination date: 2014-07-23
Voluntary/Mandated: Voluntary: Firm initiated
Location: Sellersville, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-606-2013