Actavis Inc. Issues a Voluntary Recall of Certain Fentanyl Patches
18 lots of Fentanyl Transdermal System 25-mcg/hour C-II patches are being recalled from store and pharmacy shelves because lab tests showed the active ingredient in one batch of patches was releasing medication into the bloodstream faster than the approved specifications permit.
Fentanyl patches are a popular type of treatment for the management of moderate to severe chronic pain. The patches release a steady and controlled stream of opiod fentanyl through the skin. Release of this ingredient at an increased speed can lead to a variety of problems including breathing and respiratory issues, increased sedation, hypoventilation and apnea. Actavis Inc., the manufacturer of the drug, however, says it is not aware of any injuries linked to this issue.
The recalled patches were manufactured in Grand Rapids, Michigan by Corium International, the same company that manufactured fentanyl patches for Actavis that were recalled in 2008 because of a leakage problem which had the dangerous potential of leading to an overdose.
The patches included in the recall have expiration dates varying from December 2011 to April 2012. While the safety alerts by the Food and Drug Administration and Actavis are targeting retailers and wholesalers, they are not telling consumers themselves to dispose of the patches they already have in their medicine cabinet.
The American Pain Foundation does not agree with this message and is taking measures into its own hands. The company has sent out email alerts to all its members and is willing to help consumers obtain replacement patches.
