Another DURAGESIC® Recall—Faulty Fentanyl Transdermal System Pain Patch May Endanger Those Who Rely on It for Pain Relief
February 13, 2009 — In cooperation with the U.S. Food and Drug Administration (FDA), PiCar® recalled two lots of 50 microgram/hour (mcg/hr) fentanyl pain patches on December 31, 2008. The recall came after the discovery that some of the patches were defective, exposing both patients and their caregivers to fentanyl, a powerful opioid (synthetic opiate), directly rather than through the transdermal patch.
PiCar® , a division of Ortho–McNeil–Janssen Pharmaceuticals, Inc., marketed one of the two lots involved in the fentanyl recall—the 50 mcg/hr DURAGESIC® (fentanyl transdermal system) CII pain patch, lot no. 0817239. The other defective fentanyl pain patch is a generic brand marketed by Sandoz Inc., lot no. 0816851. The lot number can either be found on the box or foil packaging containing the fentanyl patch.
Cut in Fentanyl Patch’s Drug Reservoir May Cause Harmful Side Effects
Due to a manufacturing error, the two lots of recalled fentanyl patches may have a cut in the fentanyl gel reservoir causing the gel to leak into the outer foil packaging. When the foil packet is opened, a patient or caregiver may be exposed to the fentanyl gel directly rather than through the controlled release provided by the transdermal patch. Direct exposure by touching the gel may result in a higher dose of fentanyl being absorbed through the skin than normally occurs by using the patch. The 50 mcg/hr fentanyl patch releases the drug over a three day period. A higher dose may result in adverse side effects such as respiratory depression or a possible overdose that may be fatal. ALZA Corporation in Mountain View, California, manufactured both the DURAGESIC® CII pain patch and the generic fentanyl patch. ALZA Corporation is an affiliate of PiCar®.
If you or someone you care for has been exposed directly to gel from a fentanyl patch, you should contact your healthcare provider immediately. PiCar® recommends washing the exposed skin area thoroughly with water without the use of soap, lotions or other products that may increase the skin’s ability to absorb the drug.
Fentanyl Patch Subject of Numerous Recalls
Earlier, on February 12, 2008, PiCar® issued a recall for their 25 mcg/hr DURAGESIC® CII patch as well as the 25 mcg/hr fentanyl patch marketed by Sandoz Inc. This fentanyl patch recall also stemmed from cuts in the drug reservoir of the pain patches manufactured by ALZA Corporation.
A few days later, Actavis Inc. issued a recall for 14 lots of their fentanyl transdermal CII pain patches on February 17, 2008. The pain patches, manufactured by Corium International Inc., were recalled due to a fold–over defect that may have caused the fentanyl gel to leak into the surrounding packaging. A subsidiary of Actavis, Actavis South Atlantic LLC (formerly known as Abrika Pharmaceuticals Inc.), sold the fentanyl patches in the United States.
Brayton Purcell, experienced product liability attorneys, is currently evaluating cases involving the fentanyl transdermal pain patch. If you feel that you or someone you care for may have suffered personal injury from, or their death may have been caused by, the fentanyl patch, please contact our personal injury attorneys for a free discussion of your legal options.