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A Duragesic recall was issued on February 12, 2008 for 25-mcg Duragesic patches with an expiration date that falls on or before December 2009. Duragesic dermal patches are usually prescribed for severe and chronic pain in patients who have developed a tolerance for less-powerful painkillers, but some physicians have prescribed the patches for maladies such as headaches or post-surgery pain.

Fentanyl Patch Recall

The Duragesic recall was issued when it was discovered that some of the patches may contain a defect and leak the extremely powerful drug inside the patch — fentanyl, an opiate narcotic that is 80–100 times stronger than morphine. Fentanyl is so strong that its distribution is monitored by the Drug Enforcement Agency. Fentanyl overdoses have killed hundreds of people in the U.S.

This latest recall is the fifth recall since 1994 of one version or another of the Duragesic patches. Previous recalls have also involved possible Fentanyl leaks in the patches.

Potentially Fatal Defect

Fentanyl that is mistakenly leaked from a patch may be touched by the wearer or another person, and this direct contact with fentanyl can cause a breathing difficulty or a fatal overdose of the drug.

A Johnson & Johnson Product

The patches that are the subject of the most recent recall were manufactured by ALZA Corporation, an affiliate of PriCara. Duragesic patches are prescribed worldwide, accounting for more than $1 billion in sales for Johnson & Johnson, the parent company. In Canada, the Duragesic patches are sold by Janssen-Ortho Inc. A generic version is sold by Ranbaxy Laboratories.

The U.S. Food and Drug Administration (FDA) has been closely monitoring the use (and misuse) of Duragesic patches and other fentanyl patches, and has issued safety warnings about the patches to physicians and patients.

If You're Concerned about the Recall

The latest Duragesic recall adds to the existing serious concerns about fentanyl patches. If you have questions about Duragesic dermal patches or you have been injured by a defective patch, contact our Fentanyl attorney to discuss your questions and concerns.