Duragesic Patch Recall Information
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FDA issues alert on all Fentanyl Pain Patches - including Duragesic.

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Duragesic Patch Recall News

April 7, 2004

KEY INFORMATION FOR PATIENTS AND CAREGIVERS

  • 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.


FREQUENTLY ASKED QUESTIONS

Q. What is the problem with DURAGESIC patches?
A1. Medication may leak from a small percentage of DURAGESIC patches due to the improper sealing of one of the patch edges.

Q. How can patients determine if they have an affected patch?
A2. The control number for the affected patches appears on both the outer carton and on each foil pouch that contains a patch. Though only the DURAGESIC 75 mcg per hour dose is presently affected, all patches are potentially dangerous, and leaks and similar problems have also been reported for other strength patches and other lot numbers.


Q. What should a patient or caregiver do if the patient is wearing a patch from this lot number?
A3. The patch must be removed and replaced with a new, unaffected patch as soon as possible. Whoever is removing the patch should:
  • Remove the patch, wearing rubber gloves if possible, or using a tissue.
  • Rinse their hands and the area where the patch was applied gently with a soft cloth and plain water. Do not use soap. Do not rub excessively.
  • Fold the patch in half and flush it down the toilet immediately upon removal.
  • A patch from a new carton needs to be applied as soon as possible, so the patient or caregiver should contact their physician immediately to get a new prescription, which is needed to obtain a new supply of patches from their pharmacist.

Q. What can happen to patients if they use a patch that has a leak?
A5. Exposure of the patient's or caregiver's skin to any leaked medication from a DURAGESIC patch may cause nausea, sedation, drowsiness, or potentially life-threatening complications. If the medication leaks from the patch, patients can get either too little or too much medication:
  • If medication leaks from the patch, there is no longer adequate medicine in the patch, and this can lead to withdrawal symptoms and inadequate pain relief. Symptoms include sweating, sleeplessness, and abdominal discomfort.
  • If the medication leaks directly onto the skin, a higher than intended amount can be absorbed through the skin into the body, causing nausea, sedation, drowsiness, or potentially life-threatening complications.

Q. What if the patient has a rash from the leaked medication?
A6. They should contact their physician as soon as possible.

Q. What happens if a patient has already used a patch from this lot?

A7. If you have used a recalled patch, talk to an attorney who can help you explore your legal options.

Q. What if a patient is wearing a DURAGESIC patch with another control number?
A9. While only 75 mcg per hour DURAGESIC patches have been recalled, leaks and similar problems have also been reported for other strengths and other lot numbers. Patients wearing 25 mcg per hour, 50 mcg per hour or 100 mcg per hour patches need to be aware of potential risks. See your physician - sudden discontinuation of DURAGESIC can cause health problems.


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