18 Lots of Fentanyl Transdermal System 25 mcg/h Recalled

Washington, DC: Further to its previously announced recall of 18 lots of Fentanyl Transdermal System 25 mcg/hour C-II patches, Actavis is encouraging consumers to return any product in their possession from the October 21, 2010 recall.

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

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.

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.

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

Corium, a third party supplier for Actavis, manufactured the recalled patches at their Grand Rapids, Michigan facility.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

NOV-04-10: Actavis Inc. Issues a Voluntary Recall of 18 Lots of Fentanyl Transdermal System 25 mcg/h [FDA: RECALLS]

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Published on Nov-4-10