The FDA reports that PriCara and Sandoz, Inc. have announced a voluntary nationwide recall of all lots of 25 mcg/hr Duragesic Patches (fentanyl transdermal system) sold in the U.S. All 25 mcg/hr fentanyl patches manufactured by ALZA Corporation and sold in Canada are also being recalled. The recalled patches all have expiration dates on or before December 2009.
The patches are being recalled because they may have a cut along one side of the drug reservoir within the patch, which may result in the possible release of fentanyl gel that could expose patients or caregivers directly to fentanyl gel on the skin. Fentanyl is a potent Schedule II opioid medication and exposure to the gel may lead to serious adverse events, including respiratory depression and possible overdose that may be fatal.
If you have 25 mcg/hr Duragesic or Sandoz, Inc. fentanyl patches, check the box or foil pouch for an expiration date on or before December 2009. According to PriCara, the cut edge in affected patches can be seen upon opening the sealed foil pouch. Affected patches should not be handled directly. If you do come in contact with fentanyl gel, thoroughly rinse the exposed skin with large amounts of water only. Do not use soap. Immediately dispose of affected patches by flushing them down the toilet, using caution not to handle them directly.
Anyone with recalled 25 mcg/hr Duragesic patches should call: 800-547-6446.
Anyone with recalled 25 mcg/hr Sandoz, Inc. fentanyl patches should call: 800-901-7236.
For more details about the recall, read PriCara’s press release.
Published On: February 18, 2008