May 2013 FDA Recall Drug by Teva Pharmaceuticals Usa, Inc.
D-606-2013 - Failed Dissolution Specification; during stability testing

This Class II drug recall was voluntarily initiated by Teva Pharmaceuticals Usa, Inc. on May 28, 2013 for the product Drug. The FDA reported the reason for recall as failed dissolution specification; during stability testing. The product was distributed in Product was distributed within the United States to FL, IL, MA, MO, MS, OH and TX. No government or foreign distribution. and the recall is currently terminated.

Recall Number: D-606-2013

Reason for Recall
Failed Dissolution Specification; during stability testing
Initiated
05-28-2013
Reported
06-26-2013
Quantity
316 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
65298
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Teva Pharmaceuticals USA, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed within the United States to FL, IL, MA, MO, MS, OH and TX. No government or foreign distribution.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-23-2014
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# Lot C88583, exp. 06/15