Fentanyl Patches With Reservoir Design Recalled

Two drugmakers recently recalled their fentanyl transdermal patches due to concerns that the pain medicine contained in the patch could leak into the packaging, potentially causing serious adverse events such as fatal overdose and respiratory depression.

The patches subject to the recall use a reservoir design — a rectangular transparent unit with four functional layers and a drug-containing reservoir of fentanyl and alcohol USP.

Johnson & Johnson (J&J) manufactures the recalled Duragesic (fentanyl) patch, which is marketed by its subsidiary PriCara and Sandoz, the generic unit of Novartis. J&J recalled all lots of its 25-microgram/hour Duragesic system because the patches may have a cut along one side of the drug reservoir, allowing the fentanyl gel to leak into the packaging.

Actavis also recalled its 25-, 50-, 75- and 100-microgram/hour generic Duragesic patches, produced by contract manufacturer Corium, due to a fold-over defect that can cause the patch reservoir to leak. The recall is a precautionary measure.