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URGENT Product Recall - Duragesic/Fentanyl Patch!

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  • URGENT Product Recall - Duragesic/Fentanyl Patch!

    DURAGESIC® (fentanyl transdermal system) complete U.S. prescribing information


    URGENT PRODUCT RECALL

    JANSSEN PHARMACEUTICA ANNOUNCES RECALL OF ONE LOT (CONTROL NUMBER 0327192) OF 75 MCG/HOUR DURAGESIC® (FENTANYL TRANSDERMAL SYSTEM CII) PATCHES

    TITUSVILLE, NJ, February 16, 2004 - Janssen Pharmaceutica Products, L.P., is recalling one manufacturing lot (control number 0327192) of the 75 mcg per hour strength of its prescription DURAGESIC® (fentanyl transdermal system CII) patches, which are used to treat moderate to severe chronic pain. A small percentage of these patches, which were distributed only in the U.S., may leak medication along one edge. No other lots or dosage strengths are affected. The company has consulted with the U.S. Food and Drug Administration. (For more detailed information, see www.Duragesic.com.)

    If the medication leaks from the patch, patients can get either too much or too little medication. Exposure to too much medication can occur if the medicine leaks directly onto the skin and the body absorbs a higher than intended amount. This overexposure may cause nausea, sedation, drowsiness, or potentially life-threatening complications. If the medication leaks out, there may not be enough to provide adequate pain control and the patient may experience withdrawal symptoms. These include sweating, sleeplessness, and abdominal discomfort.

    Healthcare professionals, caregivers, or anyone who comes in contact with an affected patch from this lot (DURAGESIC 75 mcg per hour, control number 0327192) also may be at risk. Anyone who comes in contact with the leaked medication should thoroughly rinse exposed skin with water only; do not use soap.

    Anyone who has 75 mcg per hour DURAGESIC patches should check the outer carton or foil pouch for the control number 0327192. Those who have patches from the affected lot must contact their physician or pharmacist immediately for specific instructions and to coordinate returning affected patches and obtaining a new supply. Patients wearing DURAGESIC patches that are not from the affected lot can continue to wear them with confidence. Sudden discontinuation of DURAGESIC can cause health problems.

    DURAGESIC is a prescription transdermal opioid medication indicated for the treatment of moderate to severe chronic pain. DURAGESIC patches are available in four dosage strengths - 25 mcg per hour, 50 mcg per hour, 75 mcg per hour and 100 mcg per hour. This voluntary recall affects one lot (control number 0327192) of the 75 mcg per hour dosage strength. No other lots of the 75 mcg per hour dosage strength are affected. No other dosage strengths are affected.

    The company estimates that significantly fewer than 19,000 patches, or less than five percent of this lot, are affected by this problem. This quantity represents much less than one percent of the total DURAGESIC patches that are currently in distribution. The affected lot was shipped to distributors in the United States between mid-December 2003 and early January 2004.

    Janssen Pharmaceutica is committed to the integrity of its products and the health and safety of the patients who use its products. For information on this product recall, please visit www.Duragesic.com or www.Janssen.com. The Web sites contain written material and photos of the pouch illustrating the control number. For those without Internet access or to report an adverse event, please call 1-800-JANSSEN (1-800-526-7736).
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