The U.S. Food and Drug Administration (FDA) announced a recall of certain lots of the Fentanyl Transdermal System, Oct. 21, 2010. Actavis Inc. issued the voluntary recall based on findings that some of the patches may release too much of the active ingredient, Fentanyl.
According to the FDA, when too much Fentanyl is released through a patch, a patient is at risk of harmful injuries, including “excessive sedation, respiratory depression, hypoventilation (slow breathing), and apnea (temporary suspension of breathing).”
Fentanyl Transdermal Systems are intended to help patients manage persistent moderate to severe pain. Actavis identified one defective pain patch that released Fentanyl faster than the approved rate. The patch belonged to control/lot number 30349.
The company included the following 18 lots in the recall:
- 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
The FDA and Actavis are requesting that the recalled patches be returned.