Johnson & Johnson Unit Recalls Some Transdermal Pain Patches

The Ortho-McNeil-Janssen unit of drug and consumer giant Johnson & Johnson is voluntarily recalling all of its 25 microgram-per-hour-strength Duragesic pain patches, which the company said have the potential to expose patients to a dangerous gel inside. Duragesic is used to manage persistent moderate to severe chronic pain that needs to be treated around the clock. The patches are sold in the United States by PriCara, an Ortho-McNeil division, and Sandoz Inc.

The company says the recall, conducted in cooperation with the U.S. FDA, affects all lots of its 25 mcg/hr Duragesic CII patches sold in the United States with expiration dates on or before December 2009, because theses patches may have an opening that could result in release of the gel made of the drug fentanyl inside, leading to potentially serious harm.

"Exposure to fentanyl gel may lead to serious adverse events, including respiratory depression and possible overdose, which may be fatal," notes a press release from the company on the recall. "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."

The company says that anyone who has 25 mcg/hr Duragesic or Sandoz Inc. fentanyl patches (fentanyl transdermal system) should check the box or foil pouch for the expiration date to see if they have patches that are being recalled. 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 call 800-901-7236. Other strength patches (12.5, 50, 75 and 100 mcg/hr) are not affected by this recall, nor are Duragesic patches sold in Europe, Latin America, and Asia, according to the company. For more information, visit www.DURAGESIC.com or http://www.jnj.com/news/.

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