January 5, 2009

PriCara, a division of Johnson & Johnson, announced that is recalling one lot of the Duragesic pain patch and one lot of the generic Sandoz fentanyl pain patch.  The recall, conducted in conjunction with the Food and Drug Administration, was issued after the manufacturer became aware of tears in the products that could allow the fentanyl gel to leak from the patches.  There is a serious risk of respiratory problems and fentanyl overdose, which could be fatal if the gel makes direct contact with skin.

Duragesic, or fentanyl, is a powerful opioid pain reliever, which is contained between sealed layers of the patch and continuously released over a 72 hour period.  It is meant to treat persistent, chronic pain in patients two years of age or older.  Fentanyl is considered a Class II substance by the Drug Enforcement Administration, meaning that it has a high potential for abuse and overdose. 

The current recall involves Duragesic 50mcg/hr patches under the lot number 0817239, and Sandoz Inc. 50 mcg/hr patches under the lot number 0816851.  An affiliate of PriCara, ALZA Corp., manufactured the patches that are being recalled. 

PriCara warns that patients who come in contact with fentanyl gel should thoroughly wash the exposed area of the skin with water.  It should be stressed that only water should be used as anything else may increase the gel’s ability to be absorbed.  Patches with cut edges should be flushed down the toilet, and should not be directly handled. 

In February 2008, a similar recall was issued after it was uncovered that the 25 mcg/hr fentanyl patches were not properly cut.  Those patches were also manufactured by ALZA.  Currently, Johnson & Johnson and their subsidiaries face over 60 fentanyl pain patch lawsuits involving Duragesic.  The wrongful death lawsuits allege that manufacturing defects caused lethal overdoses in patients.  In the first four lawsuits involving Duragesic, Johnson & Johnson’s subsidiaries were ordered to pay over $35 million in damages to victims’ families.            

If you or a loved one suffered injuries caused by either Duragesic or Sandoz, contact us today for a confidential and free case evaluation.  

Published November 17, 2011 by