Defect Prompts Voluntary Recall of Fentanyl Patches ROCKVILLE, Md., Feb. 15 -- The makers of fentanyl transdermal patches have voluntarily recalled all 25 mcg/hour fentanyl transdermal patches sold in the U.S., according to the FDA.
The recall includes all lots of patches marketed as Duragesic CII sold by PriCara, a division of Ortho-McNeil-Janssen Pharmaceuticals and 25 mcg/hour patches marketed by Sandoz, Inc.
The move was prompted by the possibility of a cut along the side of the patch's drug reservoir, which could allow the fentanyl gel to leak out, exposing patients and caregivers to direct contact with the gel.
Such exposure may lead to serious adverse events, including respiratory depression and possible overdose, which could be fatal, the FDA said.
The FDA advised that anyone who comes in contact with fentanyl gel should thoroughly rinse exposed skin with large amounts of water only. Soap should not be used.
The agency said affected patches should be flushed down the toilet, using caution not to handle them directly.
Fentanyl patches are approved for management of persistent moderate to severe chronic pain that needs to be treated around the clock and that cannot be treated by combination narcotic, short-acting, or non-narcotic pain treatment products.
Patches with a cut edge that have leaked gel will not provide effective pain relief.
Posted by lymebytes (Member # 11830) on :
Thank you for posting this, my husband uses Sandoz patches, but a different strength than the recall, thank goodness!