Fentanyl Patch Recall
February 18, 2008
On February 14th, PriCara voluntarily recalled all lots of its Duragesic® (fentanyl transdermal system) 25 mcg/hr patches and all 25 mcg/hr fentanyl patches sold by Sandoz (expiration date on or before December 2009) from wholesalers and pharmacies as a precaution.
The 25 mcg/hr pain-killing patch was recalled because there may be a cut along one side of the drug reservoir within the patch, possibly resulting in the release of fentanyl gel into the pouch in which the patch is packaged, thus exposing patients or caregivers directly to the drug. Exposure to fentanyl gel may lead to serious adverse events, including respiratory depression and possible overdose, which may be fatal.
Patients who come in contact with fentanyl gel should thoroughly rinse exposed skin with large amounts of water only (do not use soap). Patches with cut edges should be immediately disposed of by flushing them down the toilet, making sure that they are not directly touched.
For questions about the Duragesic 25 mcg/hr patch recall, call 1-800-547-6446; for questions about Sandoz patches, call 1-800-901-7236. Patients using fentanyl patches who have medical questions should contact their health care providers. Fentanyl patches in other dosage strengths are not affected by this recall.
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