More Than One Million Fentanyl Patches Recalled

Karen Lee Richards Health Guide
  • Late yesterday Actavis Inc. announced a voluntary recall of 18 lots of Fentanyl Transdermal System 25 mcg/hour C-II patches manufactured for Actavis by Corium International in the United States.

    Actavis identified one lot of 25 mcg/hour Fentanyl patch (Control/Lot # 30349) shipped to market that contained one patch that released its active ingredient faster than the approved specification in laboratory testing. 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). The patches are packaged individually and boxed in quantities of five patches per box.

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    As a precautionary measure, although unaware of any injuries associated with this issue, in addition to the aforementioned lot, Actavis is recalling 17 additional lots.  (A lot is 12,000 boxes with 5 patches to a box.)

    For the affected lot numbers and phone numbers you can call if you have any questions, click on the following link for the FDA's recall announcement:  Fentanyl Recall

Published On: October 22, 2010