Patch Recal Claim Form *
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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. The Duragesic Pain Patch has been recalled because defects in the manufacture of the patch could lead to accidental overdoses. Johnson & Johnson is recalling about 32 million of the fentanyl-containing Duragesic Pain Patches, and the company estimates that about two out of every million patches could be defective.

The Duragesic and other similar pain patches are meant to treat persistent, moderate to severe chronic pain in opioid-tolerant patients 2 years of age or older. Fentanyl is a highly addictive opiate that is 80 times more potent than morphine. Fentanyl is considered a Class II substance by the Drug Enforcement Administration, meaning it is associated with a high potential for abuse and a risk for fatal overdose.

Today’s Duragesic Patch recall includes all 25-microgram-per-hour patches that are sold in the U.S. by J&J’s PriCara unit and Sandoz; they are made by another J&J unit, Alza Corp. 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 which can be fatal. The 25-microgram-per-hour patches are prescribed mainly for lower-weight patients, children and patients just starting on the medicine.

The Duragesic Pain Patch has been a problematic device ever since it first came on the market. In 2004, 75 microgram-per-hour patches where recalled by Janssen Pharmaceutica Products for a similar leakage issue. In December, the Food & Drug Administration (FDA) issued an alert, warning patients and doctors that there was a high danger of accidental overdose associated with the use of the Duragesic Pain Patch. At the time, the FDA attributed the overdoses to patch “misuse” and ordered all fentanyl patch makers to create special “medication guides” for patients that spell out the dangers of overdoses and improper use in easy-to-understand language.

The December warning marked the second time the FDA had cautioned the public about overdose dangers associated with the Duragesic Pain Patch. In July 2005, the FDA issued a Public Health Advisory announcing its investigation of “death and other serious side effects involving overdoses” in patients using both the Duragesic painkilling patches and their generic competitors. At that time, the FDA said it had received 120 reports of deaths related to fentanyl pain patches. Between the 2005 and 2006 warnings, the FDA apparently received many more reports of accidental overdoses associated with the Duragesic Pain Patch, but declined to say how many.

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.

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Pain Patch Recall Claim Form

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