Fentanyl (Duragesic) Patch Recall

On February 12, 2008, PriCara, an affiliate of Ortho-McNeill-Janssen Pharmaceuticals, issued a recall on its Duragesic painkiller patches. Every 25 microgram-per-hour patch that has been released into retail outlets containing an expiration date of December 2009 or earlier is included.

The Problem with Duragesic Patches

Duragesic patches are capable of giving users up to three consecutive days of pain relief. Its primary ingredient, fentanyl, is a very potent opioid that is more powerful than morphine. Generally, cancer patients or people experiencing chronic pain are given prescriptions for fentanyl patches. However, the Food and Drug Administration (FDA) obtained reports showing that Duragesic has also been prescribed for pain relief following surgery as well as extreme headaches.

The PriCara Recall

PriCara announced this recall when the FDA brought the effectiveness of the drug into question. Studies revealed that fentanyl gel had been leaking from a pocket inside the patch; once the lining of the patch is damaged and gel seeps through, any contact between the gel and the patient has proven to have deadly effects.

According to PriCara, approximately one in every 500,000 Duragesic patches is prone to leakage. Although this seems like such a tiny percentage, the fact that any user is potentially endangered by the drug validated the recall.