Mylan announces no need for recall due to matrix design of Fentanyl patch

PITTSBURG As a result of the recall initiated by Ortho-McNeil-Janssen Pharmaceuticals for 25 mcg/hr Duragesic sold by Pricara, Mylan has announced that its product, the Fentanyl Transdermal System, will not take part.

According to published reports, all 25 mcg/hr Fentanyl patches are being voluntarily recalled by pharmacies and wholesalers, because during manufacturing there may have been a cut along one side of the drug reservoir within the patch. Mylan’s FTS patch does not fit this category, however, because it is made up of a matrix patch—rather than a reservoir patch—which does not leak.

“We have always believed that our Fentanyl Transdermal System is differentiated from all other Fentanyl patches in the U.S. market because of its unique matrix design,” said Mylan vice chairman and chief executive officer Robert Coury, “This is an important product characteristic that should be recognized and understood when choosing a Fentanyl Transdermal System.”