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Sandoz Fentanyl Patch Recall 

Sandoz Patch Recall News

PriCara? RECALLS 25 mcg/hr DURAGESIC® (fentanyl transdermal system) CII PAIN PATCHES

Other Strength Patches (12.5, 50, 75 and 100 mcg/hr) Not Affected

Raritan, NJ February 12, 2008 - PriCara,? Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. said today that all lots of 25 microgram/hour (mcg/hr) DURAGESIC® (fentanyl transdermal system) CII patches sold by PriCara in the United States and all 25 mcg/hr fentanyl patches sold by Sandoz Inc. in the United States are being voluntarily recalled as a precaution from wholesalers and pharmacies. The recalled patches all have expiration dates on or before December 2009, and all are manufactured by ALZA Corporation, an affiliate of PriCara. The recall is being conducted in cooperation with the U.S. Food and Drug Administration. All 25 mcg/hr fentanyl patches manufactured by ALZA and sold in Canada also are being recalled.

DURAGESIC 25 mcg/hr (fentanyl transdermal system) and Sandoz Inc. 25 mcg/hr fentanyl transdermal system patches being recalled may have a cut along one side of the drug reservoir within the patch. The result is possible release of fentanyl gel from the gel reservoir into the pouch in which the patch is packaged, exposing patients or caregivers directly to fentanyl gel. As per the approved product labeling for DURAGESIC, fentanyl is a potent Schedule II opioid medication. Fentanyl patches that are cut or damaged in any way should not be used. Exposure to fentanyl gel may lead to serious adverse events, including respiratory depression and possible overdose, which may be fatal. Anyone who comes in contact with fentanyl gel should thoroughly rinse exposed skin with large amounts of water only; do not use soap. Immediately dispose of affected patches with cut edges by flushing them down the toilet, using caution not to handle them directly. Patches with a cut edge that have leaked gel will not provide effective pain relief.

Anyone who has 25 mcg/hr DURAGESIC or Sandoz Inc. fentanyl patches should check the box or foil pouch for the expiration date to see if they have patches that are being recalled. The recalled patches all have expiration dates on or before December 2009. The cut edge in affected patches can be seen upon opening the sealed foil pouch that holds the patch. Affected patches should not be handled directly.

Fentanyl Overdose Deaths, Fentanyl Toxicity Death, Patch Recall Lawsuits. Get Latest Fentanyl Morphine Patch Recall & Fentanyl Side Effects Information. Talk to a Fentanyl Patch Attorney about filing a Fentanyl Patch overdose wrongful death lawsuit or Fentanyl Class Action Lawsuit

NOTE: As of February 12, 2008 the FDA.announced a PARTIAL Duragesic Patch Recall.

Duragesic Press Release from PriCara, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc PriCara RECALLS 25 mcg/hr DURAGESIC® (fentanyl transdermal system) CII PAIN PATCHES NOTE: Other Strength Patches (12.5, 50, 75 and 100 mcg/hr) NOT Affected.  

All patients that are using affected Duragesic patches or others affected by the recall of Duragesic Patches, should contact their doctors immediately to discuss other medical options that may be available to them. This site is not intended to provide medical information and should not be relied on by anyone. All patients with questions concerning the Duragesic Patch Recall or medical problems should immediately speak to their doctors. This website is not affliated with the manufacturers of Duragesic,any distrubutor.  All trademarks are owned by the owners of such trademarks

     

 

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