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Actavis Encourages Consumers to Return Fentanyl Transdermal System 25 mcg/h

Wed, 11/03/2010 - 9:34pm
Bio-Medicine.Org

MORRISTOWN, N.J., Nov. 3, 2010 /PRNewswire/ -- Further to its previously announced voluntary 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.

Consumers with Actavis 25 mcg/h Fentanyl patches may call 1-877-422-7452 (24 hours/day, 7 days/week) for return instructions and information.

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.

Recalled Control/Lot #s

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

Corium International Inc., a third-party supplier for Actavis, manufactured the recalled patches at its Grand Rapids, Michigan facility. 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 opi

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