FDA-Drug2013-06-26Class II
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
Teva Pharmaceuticals USA, Inc.
Hazard
Failed Dissolution Specification; during stability testing
Sold states
Product was distributed within the United States to FL, IL, MA, MO, MS, OH and TX. No government or foreign distribution.
Affected count
316 cartons
Manufactured in
650 Cathill Rd, Sellersville, PA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-606-2013Don't want to check this manually?
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