Consumer Alert: Fentanyl Patches Recalled

On February 12, 2008, PriCara announced that patches containing the prescription painkiller "Fentanyl" are being recalled.  According to the PriCara Web site, the 25 microgram-per-hour Fentanyl patches are being recalled due to potentially fatal flaws that could result in a lethal overdose to patients.[1]  Fentanyl is a potent Schedule II opioid medication, and exposure to Fentanyl gel can lead to very serious adverse events, including respiratory depression and death.[2]

According to the PriCara Web site, the 25 mcg patches recalled may have a cut along one side of the drug reservoir within the patch, potentially exposing patients to a potentially fatal overdose of Fentanyl.[3]  The patches have been sold in the United Stated under the brand name "Duragesic" by PriCara.[4]  Generic versions were sold by Sandoz, Incorporated.  All of the recalled patches have expiration dates on or before December of 2009, and were manufactured by a PriCara affiliate, the ALZA Corporation, which is a division of Ortho-McNeil-Janssen Pharmaceuticals, Incorporated.[5]  PriCara, the ALZA Corporation and Ortho-McNeil-Janssen are all subsidiaries of the Johnson & Johnson Company.[6]

Previously, in July of 2005, the FDA issued an advisory emphasizing the limited safe uses of the Fentanyl patch.[7]  Despite the advisory, the FDA apparently continued to receive reports of death and life-threatening events in patients who suffered overdoses while using the Fentanyl patches, and the FDA issued an updated advisory on December 21, 2007.[8]  In the Advisory, the FDA stated that the Fentanyl patch "is only indicated for use in patients with persistent, moderate-to-severe chronic pain who have been taking a regular, daily, around-the-clock narcotic pain medicine for longer than a week and are considered to be opioid-tolerant."[9]

If you or someone you know has been injured or killed while using the Fentanyl patch and you wish to consult with a lawyer, please send an e-mail by clicking on this link: contact us

[1] PriCara Web site, available at
[2] Id.
[3] Id.
[4] Id.
[5] Id.
[6] Johnson & Johnson Website, available at
[7] U.S. Food and Drug Administration, Public Health Advisory: Important Information for the Safe Use of Fentanyl Transdermal System (Patch), available at
[8] U.S. Food and Drug Administration, Information for Healthcare Professionals: Fentanyl Transdermal System (marketed as Duragesic and generics), available at
[9] Id.

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