PriCara, a division of Ortho-McNeil Janssen Pharmaceuticals, has voluntarily recalled one lot of 50micrograms/hour Duragesic (fentanyl transdermal system) CII patches and one lot of 50micrograms/hour fentanyl patches sold by Sandoz due to a cut-system defect. The affected patches may have a cut along one side of the drug reservoir that may release fentanyl gel from the gel reservoir into the pouch in which the patch is packaged, exposing patients and caregivers directly to fentanyl gel. Exposure to fentanyl gel may lead to serious adverse events, including respiratory depression and possible overdose, which may be fatal.
The recalled lots are Duragesic 50mcg/hr patches lot number 0817239 and Sandoz 50mcg/hr fentanyl patches lot number 0816851. The 12.5mcg/hr, 25mcg/hr, 75mcg/hr, and 100mcg/hr patches are not affected.
For more information call PriCara at (800) 547-6446 or Sandoz at (800) 901-7236.