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Fentanyl Pain Patch Recall 

Fentanyl Pain Patch Recall - Overdose Deaths

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.  

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.

FDA Alerts concerning Duragesic Patches

FOR IMMEDIATE RELEASE -- 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.

Anyone with 25 mcg/hr DURAGESIC patches being recalled should call 800-547-6446.

Anyone with 25 mcg/hr Sandoz Inc. patches being recalled should call 800-901-7236.

Patients using fentanyl patches who have medical questions should contact their health-care providers.

DURAGESIC is used to manage persistent moderate to severe chronic pain that needs to be treated around the clock and which cannot be treated by: combination narcotic, short-acting, or non-narcotic pain treatment products. It should only be used by people who are receiving or have developed a tolerance to pain therapy with opioids. DURAGESIC should not be used if patients have pain that will go away in a few days, such as pain from surgery, medical or dental procedures, or short-lasting conditions. Any adverse reactions experienced with the use of fentanyl patches should be reported to the appropriate company using the telephone numbers above. DURAGESIC brand and other fentanyl patches are available by prescription only, through pharmacies, and should be used only under the supervision of a physician.DUROGESIC patches sold in Europe, Latin America and Asia are not affected by this recall.

Duragesic Patch Lawsuits & Class Actions

If you have suffered serious injuries or have lost a loved one due to an overdose of a DURAGESIC® due to the defective nature of the product packaging, then you may be eligible to file a products liability lawsuit / or a Duragesic Patch Lawsuit for your injuries and losses.

Call and talk to a law firm that understands product liability lawsuits and class action lawsuits and the dangerous side affects from a overdose of fentanyl (a potent Schedule II opioid medication). Also, if you have sufffered an injury or loss of a loved one, it is very important that you discuss your legal rights and options with a lawyer. The proper & safe storage of the evidence in any product liability lawsuit is critical. Call us with your questions.

Willis Law Firm - Houston, Texas Drug Recall Lawyers Attorneys Free Lawsuit & Class Action Litigation Consultation


   

  

Also see: http://www.fda-recalls.us/

CPSC Product Recall Alert

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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NSF from MRI Gadolinium Contrast Dye in Kidney Failure, Dialysis Patients & Renal Failure  The FDA has reported a possible link between NSF/NFD, kidney failure and renal failure and the exposure to MRI dye / contrast called gadolinium. Patients with kidney disease, kidney failure, kidney or renal insufficeincy and kidney patients on kidney dialysis, may have contracted a horrible fibrosing skin disease from the gadolinium based contrast dyes used in MRIs. These MRI dyes have serious side effects which includes a rare skin, muscle & joint disorder called Nephrogenic Systemic Fibrosis (NSF). Patients with NSF often develop large areas of hardened skin with fibrotic nodules and plaques, reddened skin, muscle tightening, muscle weakness, joint pain and burning in joints along with itchy, thick areas of skin, usually on one's limbs. Click here for more information about Nephrogenic Systemic Fibrosis (NSF)  Recent reports link fractured femurs to the use of Fosamax. If you have fractured your leg or femur and have taken fosamx get a free case evaluation at www.fosamax-femur-fractures.com Fosamax Femur Fracture Lawsuits Fosamax Lawsuits Recent RFDA Depakote alert warns of Depakote use during pregnancy. Depakote may cause harm to the fetus resulting in spinal bifida, neural tube defects, growth retardation and other birth defects. For more information see depakote spina bifida  FDA warning Reglan may cause Tardive Dyskinesia (TD) a rare side effect of long time Reglan usage. Reglan has been linked to Tardive Dyskinesia. Tardive Dyskinesia is a central nervous system disorder characterized by involuntary movements of the limbs as well as twitching of the face and tongue similar to Parkinson's disease. See Metoclopramide and Tardive Dyskinesia TD for more information about reglan side effects. See Reglan Tardive Dyskinesia (TD) side effects lawsuits. Dilantin can cause SJS Stevens Johnson Syndrome and TENS. Get more info about Dilantin SJS Stevens Johnson Syndrome Lawsuit  Dilantin also can cause TEN (Toxic Epidermal Necrolysis) are more severe than others. Erythema multiforme minor is the milder form of SJS and not as serious as Erythema multiforme majoris. However, full blown Stevens-Johnson syndrone. If you or a loved one have taken Dilantin (phenytoin),Tegretol (carbamazepine), Lamictal (lamotrigue) or Levaquin (levofloxacin) and have been diagnosed with SJS or TENS or a loved one has died for complications of SJS Syndrome or TEN, Stevens-Johnson Syndrome (SJS) is a life-threatening condition affecting the skin in which cell death causes the epidermis (the outer layers of skin) separating from the dermis (inner layers of skin). See information about Stevens-Johnson Syndrome (SJS) Dilantin Lawsuit.Talk to a Dilantin SJS Dilantin Stevens Johnson Syndrome SJS Dilantin TEN lawyer about Dilantin TEN Toxic Epidermal Necrolysis Diagosis and your legal rights to a Dilantin lawsuit .Byetta Pancreatitis Lawsuits Toyota Gas Pedal Recall News

 

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