FDA MedWatch News Fentanyl Patch Recall
 
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FDA MedWatch


02/19/2008 -  Actavis Inc. announced a nationwide recall of certain lots of Fentanyl transdermal system CII Patches sold in the United States and labelled with an Abrika or Actavis label. The product may have a fold-over defect which can cause the patch to leak and expose patients or caregivers directly to the fentanyl gel. Exposure to fentanyl gel may lead to serious adverse events, including respiratory depression and possible overdose, which may be fatal. The lots covered by this recall include doses of 25, 50, 75, and 100 mcg/hr and are listed in the firm's press release.

See the complete MedWatch 2008 safety summary, including a link to the firm's press release, at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Fentanyl

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