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Durageic Recall, Duragesic® Patch Defect

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Yet another Duragesic® patch recall was issued in January 2009. A division of Ortho-McNeil Janssen Pharmaceuticals named PriCara voluntarily recalled two lots of 50 microgram per hour (mcg/hr) Duragesic® CII patches sold in the U.S. The recall was conducted "as a precaution," in cooperation with the FDA (the U.S. Food and Drug Administration). Potential leaks in the fentanyl reservoir were the reason for this latest recall.

Defective Duragesic® Patches

PriCara and another company, Sandoz Inc. were selling the Duragesic® patches to wholesalers and pharmacies throughout the United States. The manufacturer of the Duragesic® patches, California-based Alza Corporation, identified a manufacturing defect in some of the patches: the equipment used to manufacture the patches had put a cut along one side of the reservoir that held the gel-form fentanyl. Some of the fentanyl may have leaked into the pouches in which the patches were packaged.

Deadly Risks

Direct exposure to fentanyl can be extremely hazardous. Fentanyl is one of the strongest painkillers available — it's estimated to be 80 to 100 times as strong as morphine. That's why 'microgram' doses are used rather than milligrams. A patient or a caregiver removing the packaging for a defective Duragesic® patch could suffer respiratory problems, seizures, or other deadly side effects.

Earlier Duragesic® Patch Recall

In early 2008, nearly 100 lots of a different dosage of Duragesic® patches and generic Sandoz patches — 25 mcg/hr — were recalled because of a different manufacturing defect. Soon thereafter, all lots of fentanyl-containing transdermal patches were recalled in the U.S.

Each year, over a billion dollars in sales of Duragesic® patches are recorded. Over four million prescriptions for Duragesic® patches are written every year.

Symptoms of Duragesic® Patch Toxicity

A patient, caregiver or other individual who is exposed to a fentanyl leak from one of the recalled Duragesic® patches may experience some or all of the following symptoms:

• reduced rate and depth of breathing (hypoventilation)
• cold or clammy skin
• low blood pressure
• pinpoint pupils of the eyes
• slow or weak heartbeat

If You Have Been Injured by the Duragesic® Patch

Have you or a loved one been injured after using the Duragesic® Patch? If so, contact us to speak with an experienced Duragesic® Patch attorney who specializes in drug recall litigation & lawsuits. Let us help you win the compensation you need and deserve.