Product Detail

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

Recall Number D-606-2013

Classification Class II

Code Info Lot C88583, exp. 06/15

Product Distributed Qty 316 cartons

Reason For Recall Subpotent Drug: Product is being recalled due to an out of specification dissolution result during stability testing.

Event Detail

Event Id 65298

Product Type Drugs

Status Ongoing

Recalling Firm
Teva Pharmaceuticals USA, Inc.
City Sellersville
State PA

Country US

Voluntary / Mandated Voluntary: Firm Initiated

Recall Initiation Date 2013-05-28

Initial Firm Notification of Consignee or Public Letter

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