The voluntary recall applies to the following products with an expiration date on or before December 2009:
- Duragesic pain patch sold by PriCara in the U.S. in the 25 mcg/hr (micrograms per hour) strength
- Generic fentanyl patches sold in the U.S. by Sandoz in the 25 mcg/hr strength
- 25 mcg/hr fentanyl patches made by Alza Corp. and sold in Canada.
Duragesic and fentanyl patches in other strengths aren't being recalled.
All of the recalled patches were made by Alza Corp., an affiliate of PriCara, which is a division of Ortho-McNeil-Janssen Pharmaceuticals. PriCara announced the recalls in a news release.
Recall Is a 'Precaution'
In its news release, PriCara explains that the recall is a precaution because some of the recalled patches may have a cut along one side of the patch's drug reservoir.
That cut could expose patients or caregivers directly to the drug. Such exposure may lead to serious adverse events, including respiratory depression [problems with breathing] and overdose, which may be fatal, states PriCara.
Fentanyl Pain Patch Recall: What to Do
Here's what PriCara says to do if you've got the recalled patches:
- If you have a recalled Duragesic patch, call PriCara at (800) 547-6446.
- If you have a recalled Sandoz patch, call (800) 901-7236.
- If you have patches with cut edges, flush them down the toilet. Do not handle the patches directly.
- If you come in contact with fentanyl gel, use large amounts of water -- without soap -- to thoroughly rinse the area.