Johnson & Johnson Unit Recalls 25 Mcg/Hr Duragesic Patches

February 12, 2008: 03:32 PM EST

Johnson & Johnson’s PriCara unit recalled all lots of 25-microgram-per- hour Duragesic CII pain patches that may have a cut edge that could leak fentanyl gel.

The recalled patches, manufactured by Alza Corp. and sold by PriCara and Sandoz Inc. in the U.S. and Canada, have expiration dates on or before December 2009. Patches with 12.5, 50, 75 and 100 mcg/hr strengths aren’t affected.

PriCara said it is conducting the voluntary recall in cooperation with the Food and Drug Administration.

PriCara said patches with a cut edge that have leaked gel may lead to serious adverse events including respiratory depression and possible overdose.

A PriCara spokesman said there are six confirmed reports of defective patches and about 20 patches have been returned to the company.

The spokesman said there are about 80 lots out in the U.S. and 15 lots out in Canada. A lot is composed of 400,000 units. The spokesman said the estimated defect rate is about 2 per million.

The spokesman said the company doesn’t have any financial information on the impact of the recalls at this time.

Johnson & Johnson Company Press Release

PRICARA™ RECALLS 25 mcg/hr DURAGESIC® (fentanyl transdermal system) CII PAIN PATCHES

Other Strength Patches (12.5, 50, 75 and 100 mcg/hr) Not Affected

Raritan, NJ  (February 12, 2008) – PriCara,™ Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. said today that 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 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.  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 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. Patches with a cut edge that have leaked gel will not provide effective pain relief.

Anyone who has 25 mcg/hr DURAGESIC or Sandoz Inc. fentanyl patches should check the box or foil pouch for the expiration date to see if they have patches that are being recalled. The recalled patches all have expiration dates on or before December 2009. The cut edge in affected patches can be seen upon opening the sealed foil pouch that holds the patch. Affected patches should not be handled directly.

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 call800-901-7236.

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

For more information, visit 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.