Fentanyl Transdermal System: Recall

Do you or someone you know use a Fentanyl patch for pain relief? If so, please take note of this recall.

October 21, 2010 - Morristown, NJ - Actavis Inc. today announced a voluntary recall to the wholesale and retail levels only of 18 lots of Fentanyl Transdermal System 25 mcg/hour C-II patches manufactured for Actavis by Corium International in the United States.

Actavis identified one lot of 25 mcg/hour Fentanyl patch (Control/Lot # 30349) shipped to market that contained one patch that released its active ingredient faster than the approved specification in laboratory testing. An accelerated release of Fentanyl from a 25 mcg/hour patch can lead to adverse events for at-risk patients, including excessive sedation, respiratory depression, hypoventilation (slow breathing), and apnea (temporary suspension of breathing). The patches are packaged individually and boxed in quantities of five patches per box.

Fentanyl Transdermal System is indicated for the management of persistent, moderate to severe chronic pain that requires continuous, around-the-clock opioid administration for an extended period of time and cannot be managed by other means such as non-steroidal analgesics, opioid combination products, or immediate release opioids.

As a precautionary measure, although unaware of any injuries associated with this issue, in addition to the aforementioned lot, Actavis is recalling the additional Control/Lot numbers noted below due to the possibility that additional patches may release active ingredient faster than the approved specification. The Control/Lot number appears on the bottom of the product box and on the black and white side of each individual patch packaging, in the lower left corner.

Recalled Control/Lot #s
30041, Exp 12/2011	30258, Exp 03/2012
30049, Exp 12/2011	30349, Exp 03/2012
30066, Exp 12/2011	30350, Exp 03/2012
30096, Exp 01/2012	30391, Exp 03/2012
30097, Exp 02/2012	30392, Exp 04/2012
30123, Exp 01/2012	30429, Exp 04/2012
30241, Exp 02/2012	30430, Exp 04/2012
30256, Exp 02/2012	30431, Exp 04/2012
30257, Exp 03/2012	30517, Exp 04/2012

Actavis has operators available to help customers, health professionals and consumers with the following information:

• Medical Issue/Adverse Event/Product Questions
  1-877-422-7452 (24 hours/day, 7 days/week)
• Return/Reimbursement Questions
  1-888-896-4562 (24 hours/day, 7 days/week)

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Online: www.fda.gov/medwatch/report.htm

Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form.

Fax: 1-800-FDA-0178