Duragesic Pain Patch Recall Information -
Legal Guide

NEWS: February 13, 2008
Johnson & Johnson Duragesic Pain Patch Flaw Recall.

A recall has been issued by Johnson & Johnson and Novartis AG's Sandoz on 25-microgram-per-hour patches with expiration dates on or before December 2009.

It was found that a manufacturing problem led to some of the patches having a cut in the internal reservoir lining. This cut may cause a leaking problem of the patch. The danger is if anyone touches a defective pain patch they may be delivered a dose of the prescription painkiller fentanyl which may lead to breathing problems or even an accidental overdose.

Back in December the FDA issued a safety warning on the Duragesic patch, citing improper use may cause breathing difficulties and death. The FDA continues to work with J& J on this voluntary recall and is investigating this latest issue.

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On April 5th, 2004, Janssen Pharmaceutica Products, L.P. announced that it was recalling over two million Duragesic® pain control patches due to a potentially deadly defect. The recall was for all 75 mcg. patches with the following lot numbers: 0327192, 0327193, 0327294, 0327295 and 0330362. Click here to see the photos showing the location of the control number and dosage strength.

The defect could result in a leak and lead to a dangerous overdose of the narcotic fentanyl. Fentanyl, the drug contained in the patch, is a potent opioid and a DEA Schedule II controlled substance that is up to 100 times stronger than morphine. In addition to the lots involved in the large recall, leaks and similar problems have also been reported for other strength patches and other lot numbers.

Duragesic is no longer the only fentanyl pain patch being marketed. On January 28, 2005, the U.S. Food and Drug Administration (FDA) granted final approval for Mylan Laboratories, Inc. to market a generic fentanyl transdermal system. The manufacturer of Duragesic® has also begun to market an authorized generic version of the fentanyl patch through an agreement with Sandoz. Other generic companies have applications pending at the FDA to market similar fentanyl patches, therefore, other generic versions may soon be available. Problems associated with these newer generic patches have also been reported.

It is very difficult for a person examining a fentanyl patch to detect a defect or leak. This can lead to a dangerous situation as exposure to an excessive amount of fentanyl can lead to serious injury or death.

If you have lost a loved one due to exposure to a fentanyl patch you need to seek legal guidance from an experienced attorney as soon as possible. It's important for corporations to warn their consumers about these dangerous and deadly product defects in a more timely manner. Call today.

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