Actavis Fentanyl Transdermal System 25 mcg/hour C-II Patch Recall Issued By Actavis Over Potential Release Of Active Ingredients Faster Than Approved Laboratory Testing Specification

Actavis Recalls 18 lots of Fentanyl Transdermal System 25 mcg/hour C-II Patches Over Risk Of Release Of Active Ingredient Faster Than Approved Specification in Lab Testing.

A medical patch recall has been issued by Actavis Inc. (Actavis”) recalling 18 lots of Fentanyl Transdermal System 25 mcg/hour C-II patches manufactured for Actavis by Corium International in the United States reportedly because one Fentanyl Transdermal lot shipped to market contained one patch that released its active ingredient faster than the approved specification in laboratory testing, which 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), according to a Food & Drug Administration (“FDA”) medical patch recall news report.

According to Actavis’s website, Fentanyl is a potent “Schedule 2” opioid medication indicated for 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.

The recalled Fentanyl patches include Fentanyl patches with the following control and lots numbers:

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

For more information on the Actavis Fentanyl Transdermal System patch recall, call Actavis at 1-877-422-7452 for Medical Issue, Adverse Event or Product Questions or at 1-888-896-4562 for Return or Reimbursement recall questions or visit the Actavis recall website:

www.actavis.us

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