KEY INFORMATION FOR PATIENTS AND CAREGIVERS

April 7, 2004

• Janssen Pharmaceutica Products, L.P. announced an expanded recall to users of DURAGESIC (fentanyl transdermal system) CII 75 mcg/hour, NDC #50458-035-05, control numbers 0327192 (exp. 10/05), 0327193 (exp. 10/05), 0327294 (exp. 11/05), 0327295 (exp. 11/05) and 0330362 (exp. 12/05). The company recalled one lot of DURAGESIC 75 mcg/hour patches (control number 0327192) in February 2004 after determining that a small percentage of patches in this lot might leak medication along one edge. Since then, a small number of patches with the same problem have been identified in one additional lot. As a precaution, the company is recalling four additional lots of 75 mcg/hour patches that were produced on the same manufacturing line during the same period. In addition to the lots involved in the recall, leaks and similar problems have also been reported for other strength patches and other lot numbers.

• Skin exposure to any leaked medication from a DURAGESIC patch may cause nausea, sedation, drowsiness, or potentially life-threatening complications.

• Patients or caregivers in possession of DURAGESIC patches should immediately contact their physician or pharmacist for specific instructions about returning affected patches and obtaining a new supply of medication.

• Always seek medical attention before making a decision on your particular patch. Sudden discontinuation of DURAGESIC can cause health problems.