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Thursday, February 14, 2008

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.

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