Navigation Links
PriCara(TM) Recalls 25 mcg/hr DURAGESIC(R) (fentanyl transdermal system) CII Pain Patches
Date:2/12/2008

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

RARITAN, N.J., Feb. 12 /PRNewswire/ -- PriCara(TM), Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. said today that all lots of 25 microgram/hour (mcg/hr) DURAGESIC(R) (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.

For additional information, visit http://www.DURAGESIC.com.

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(TM) patches sold in Europe, Latin America and Asia are not affected by this recall.


'/>"/>
SOURCE PriCara
Copyright©2008 PR Newswire.
All rights reserved

Related medicine news :

1. Fairbank Farms Voluntarily Recalls 85% Ground Round Beef Patties Sold Fresh from Shaws Due to Possible Health Risk
2. Studies of 20,000 smokers show quit rates double with counseling and free nicotine patches
3. No need for children with lazy eye to wear patches all day
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/7/2016)... , ... December 07, 2016 , ... "Hacking into my ... had described him as 'a genius.'" Thus begins "Margaret in Berlin," Book Twelve in ... published by Wyston Books, Inc. These novels narrate the lives of a ...
(Date:12/6/2016)... ... December 06, 2016 , ... Men with gum ... risk of serious health problems, such as cardiovascular illness, according to research cited ... Beverly Hills Periodontics & Dental Implant Center notes that the correlation between periodontal ...
(Date:12/6/2016)... ... ... An inventor, from Talladega, Ala., thought there needed to be a more ... , The SLING-VEST provides an effective way to support and align the arm or ... result, it helps to reduce discomfort and shifting. The invention features an effective design ...
(Date:12/6/2016)... ... ... Mount Sinai Health System today announced the creation of the Medical Modeling ... order 3D models for their cases. Virtual reality, simulation, and 3D printing services ... resource will be the first of its kind catering to the unique patient-specific modeling ...
(Date:12/6/2016)... Scottsdale, Arizona (PRWEB) , ... December 06, 2016 , ... ... less than fIve days after launch. Almost 200 backers pledged more than $25,000 ... life-changing technology. , Dr. Amy Serin, an Arizona Neuropsychologist and inventor, ...
Breaking Medicine News(10 mins):
(Date:12/6/2016)...  BTL Aesthetics today announced the release of ... ME device was effectively redesigned for more efficient, ... tissue. The result: Significantly better outcomes in abdominal ... ME versus BTL Vanquish. "We are ... patients with the most highly-advanced devices on the ...
(Date:12/6/2016)... 6, 2016  Arcturus Therapeutics, Inc. ("Arcturus" or ... today that it entered into collaboration with Takeda ... the treatment of NASH and other gastrointestinal (GI) ... LUNAR™ and UNA Oligomer chemistry. The financial terms ... commitment to and expertise in GI disorders, we ...
(Date:12/6/2016)... 6, 2016 A new study released today ... 340B) projects the 340B Drug Pricing Program will continue to ... it is expected to exceed $23 billion in total purchases ... purchases surpass current Medicare Part B drug reimbursement purchases over ... – based on analysis of data on total drug purchases ...
Breaking Medicine Technology: