Fentanyl Patches Recalled

Morristown, NJA number of Fentanyl Patches have been recalled by the manufacturer, Actavis Inc., because one lot was identified as having its active ingredient released faster than the approved specifications.

On its website, The US Food and Drug Administration (FDA) warns that an 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).

Actavis Inc. has recalled wholesale and retail levels only of 18 lots of Fentanyl Transdermal System 25 mcg/hour C-II patches. The recalled Control/Lot numbers are posted on the FDA recall website.