Duragesic Recall - Lawyer and Lawsuit

Below is the FDA information regarding a Duragesic recall. PritzkerOlsen, P.A. is monitoring this recall and others involving Duragesic fentanyl patches. The firm has a national product liability practice, and attorneys at the firm have been interviewed by The New York Times, The Wall Street Journal, Lawyers USA, and other publications. In recognition of their accomplishments, Fred Pritzker, Elliot Olsen and Eric Hageman have been named "Super Lawyers" by Law & Politics magazine. To contact a lawyer at PritzkerOlsen, P.A. about a Duragesic recall lawsuit, please call toll-free at 1-888-377-8900 or submit the firm's free case consultation form.

Duragesic Recall Information

A Duragesic recall has been issued by PriCara, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. All lots of 25 microgram/hour (mcg/hr) DURAGESIC® (fentanyl transdermal system) CII patches sold by PriCara in the United States and all 25 mcg/hr fentanyl patches sold by Sandoz Inc. in the United States are being voluntarily recalled as a precaution from wholesalers and pharmacies. The recalled patches all have expiration dates on or before December 2009, and all are manufactured by ALZA Corporation, an affiliate of PriCara. The recall is being conducted in cooperation with the U.S. Food and Drug Administration. All 25 mcg/hr fentanyl patches manufactured by ALZA and sold in Canada also are being recalled.

Duragesic Recall Due to Possible Release of Fentanyl Gel

DURAGESIC 25 mcg/hr (fentanyl transdermal system) and Sandoz Inc. 25 mcg/hr fentanyl transdermal system patches being recalled may have a cut along one side of the drug reservoir within the patch. 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. EXPOSURE TO EVEN SMALL AMOUNTS OF DURAGESIC FENTANYL GEL MAY LEAD TO FENTANYL OVERDOSE AND SERIOUS INJURY OR DEATH.

Anyone who comes in contact with fentanyl gel should thoroughly rinse exposed skin with large amounts of water only; do not use soap. Immediately dispose of affected patches with cut edges by flushing them down the toilet, using caution not to handle them directly.

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.

DUROGESIC™ patches sold in Europe, Latin America and Asia are not affected by this recall.

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