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PriCara™ Recalls 50 mcg/hr DURAGESIC(R) (fentanyl transdermal system) CII Pain Patches


1/2/2009 6:46:02 AM

RARITAN, N.J., Dec. 31 /PRNewswire/ -- PriCara®, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., said today that one lot of 50 microgram/hour (mcg/hr) DURAGESIC® (fentanyl transdermal system) CII patches sold by PriCara in the United States and one lot of 50 mcg/hr fentanyl patches sold by Sandoz Inc. in the United States are being voluntarily recalled as a precaution from wholesalers and pharmacies. The recall is being conducted in cooperation with the U.S. Food and Drug Administration (FDA).

The company has identified a condition in the manufacturing equipment that has since been corrected. The condition resulted in a cut-system defect in a small number of affected patches in the lots being recalled. ALZA Corporation of Mountain View, CA, an affiliate of PriCara, manufactured the patches being recalled. DURAGESIC 50 mcg/hr (fentanyl transdermal system) patches and Sandoz Inc. 50 mcg/hr fentanyl transdermal system patches being recalled may have a cut along one side of the drug reservoir. The result is possible release of fentanyl gel from the gel reservoir into the pouch in which the patch is packaged, exposing patients or caregivers directly to fentanyl gel.

As per the approved product labeling for DURAGESIC, fentanyl is a potent Schedule II opioid medication. Fentanyl patches that are cut or damaged in any way should not be used. Exposure to fentanyl gel may lead to serious adverse events, including respiratory depression and possible overdose, which may be fatal. Anyone who comes in contact with fentanyl gel should thoroughly wash exposed skin with large amounts of water only; do not use soap, alcohol, lotions, oils or other products to remove the medicine gel because they may increase the medicine's ability to go through the skin.

Immediately dispose of patches with cut edges by flushing them down the toilet, using caution not to handle them directly. Patches with a cut edge that have leaked gel will not provide effective pain relief.

DURAGESIC 50 mcg/hr patches being recalled: lot number 0817239.

Anyone with 50 mcg/hr DURAGESIC patches from this lot should call 800-547-6446.

The Sandoz Inc. 50 mcg/hr patches being recalled: lot number 0816851.

Anyone with 50 mcg/hr Sandoz Inc. patches from this lot should call 800-901-7236.

Anyone who has 50 mcg/hr DURAGESIC or 50 mcg/hr Sandoz Inc. fentanyl patches should check the box or foil pouch to see if they have patches from the recalled lots. Cut patches should not be handled directly.

Patients using fentanyl patches who have medical questions should contact their health-care providers.

For additional information, visit http://www.duragesic.com

DURAGESIC is used to manage persistent moderate to severe chronic pain that needs to be treated around the clock and which cannot be treated by: combination narcotic, short-acting, or non-narcotic pain treatment products. It should only be used by people who are receiving or have developed a tolerance to pain therapy with opioids. DURAGESIC should not be used if patients have pain that will go away in a few days, such as pain from surgery, medical or dental procedures, or short-lasting conditions. Any adverse reactions experienced with the use of fentanyl patches should be reported to the appropriate company using the telephone numbers above. DURAGESIC brand and other fentanyl patches are available by prescription only, through pharmacies, and should be used only under the supervision of a physician. DURAGESIC patches sold in Canada are not affected by this recall. DUROGESIC(TM) patches sold in Europe, Latin America and Asia are not affected by this recall.

MEDIA CONTACT: Greg Panico Office: (908) 927-3715 Mobile: (908) 240-2011

Source: PriCara, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.

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