FDAnews
www.fdanews.com/articles/104287-damaged-pain-patches-recalled

Damaged Pain Patches Recalled

February 22, 2008

Lots of PriCara’s 25-microgram/hour Duragesic CII patches and Sandoz’s fentanyl patches are being voluntarily recalled in the U.S. due to a cut along one side of the drug reservoir.

The recalled patches, which are used to treat pain, are manufactured by Alza, an affiliate of Ortho-McNeil Janssen’s PriCara division.

The cuts could allow fentanyl gel into the packaging. Exposure to the gel, which is an opioid medication, may lead to serious adverse events, including respiratory depression and possible fatal overdose, according to Ortho-McNeil.

All 25-microgram/hour fentanyl patches manufactured by Alza and sold in Canada also are being recalled.