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Recall Observatory FDA recall evidence

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

D-606-2013

May 28, 2013

Class II

Product summary

Firm
Teva Pharmaceuticals USA, Inc.
Event
Event 65298
Status
Terminated
Classification
Class II
Quantity
316 cartons
Official record key
drug-enforcement:D-606-2013

Official wording

Reason: Failed Dissolution Specification; during stability testing

Code information: Lot C88583, exp. 06/15

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

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Failed Dissolution Specification