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Teva Pharmaceuticals USA, Inc. recalls Actiq (oral transmucosal fentanyl citrate) 200 mcg, lozenge on a stick, a)Single Blister (NDC 63459-502-01), b) 30 count

Recalled June 26, 2013 · FDA recall D-606-2013 · Teva Pharmaceuticals USA

Hazard
Failed Dissolution Specification; during stability testing · FDA Class II
Units
316 cartons
Sold at
Product was distributed within the United States to FL, IL, MA, MO, MS, OH and TX. No government or foreign distribution.

Description

Failed Dissolution Specification; during stability testing

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
Manufacturer(s)
Teva Pharmaceuticals USA, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →

Teva Pharmaceuticals USA, Inc. recalls Actiq (oral transmucosal fentanyl citrate) 200 mcg, lozenge on a stick, a)Single Blister (NDC 63459-502-01), b) 30 count | RecallWatchUSA