PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: June 26, 2013 Initiated: May 28, 2013 #D-606-2013

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

Reason for Recall

Failed Dissolution Specification; during stability testing

Details

Units Affected
316 cartons
Distribution
Product was distributed within the United States to FL, IL, MA, MO, MS, OH and TX. No government or foreign distribution.
Location
Sellersville, PA

Frequently Asked Questions

What product was recalled?
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. Recalled by Teva Pharmaceuticals USA, Inc.. Units affected: 316 cartons.
Why was this product recalled?
Failed Dissolution Specification; during stability testing
Which agency issued this recall?
This recall was issued by the FDA Drug on June 26, 2013. Severity: Moderate. Recall number: D-606-2013.