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Some are leaking gel, exposing people to high doses of fentanyl.

The American Pain Foundation
A United Voice of Hope and Power over Pain




Safety Alert: Duragesic Recall
On Tuesday, February 12, 2008, PriCara, the manufacturer of transdermal fentanyl (Duragesic®), announced that supply lots of their 25mcg/hr patches were recalled due to a flaw in the cut of one edge. To be aware that some patches may unintentionally expose patients directly to the medication gel (because the integrity of the barrier could be compromised), these lots as well as those manufactured by ALZA and sold by Sandoz have been voluntarily recalled to remove them from the market place. Other strength patches (12.5, 50, 75 and 100 mcg/hr) are not affected.

If you have recently received a new supply of the 25 mcg/hr Duragesic patch with an expiration date on or before December 2009, PriCara recommends the following action:

• Check the box or foil pouch for the expiration date to see if they have patches that are being recalled (dates on or before December 2009).
• Contact the following manufacturer immediately for further instructions:
  • Anyone with 25 mcg/hr Duragesic patches being recalled should call 800-547-6446.
  • Anyone with 25 mcg/hr Sandoz Inc. patches being recalled should call 800-901-7236.
• Notify your healthcare provider who prescribed this pain medication that you have received a recalled lot.
• If you have already opened one the foiled patches that is being recalled:
  • First inspect the cut edge to see if the gel has leaked.
  • Do not use the affected patches.
  • These affected patches should not be handled directly. Place them into a plastic baggie or wrap them in aluminum foil until directed further by the manufacturer.
  • If you accidently touch the fentanyl gel, thoroughly rinse the area using a large amount of water -- without soap.
  • Contact the manufacturer and your healthcare provider as instructed above.

For additional information, please visit the following websites:

• PriCara
• WebMD

Posted February 14, 2008
Expanded Recall: Actavis Recalls Certain Fentanyl Patches in the US as Precaution
Actavis Inc., the United States manufacturing and marketing division of the international generic pharmaceutical company Actavis Group, has announced that 14 lots of fentanyl transdermal system CII patches sold in the United States by Actavis' subsidiary Actavis South Atlantic LLC are being voluntarily recalled from wholesalers and pharmacies as a precaution. They include:
Actavis Fentanyl Transdermal System, 25 mcg/hr.
Actavis Fentanyl Transdermal System, 50 mcg/hr.
Actavis Fentanyl Transdermal System, 75 mcg/hr.
Actavis Fentanyl Transdermal System, 100 mcg/hr.
Anyone with Actavis Fentanyl transdermal system patches with the above listed lot numbers should call 877-422-7452.
For more detailed information, please visit the FDA Recall Notice.
Posted February 20, 2008

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