Navigation Links
PriCara(R) Recalls 50 mcg/hr DURAGESIC(R) (fentanyl transdermal system) CII Pain Patches
Date:12/31/2008

Other Strength Patches (12.5, 25, 75 and 100 mcg/hr) Not Affected

RARITAN, N.J., Dec. 31 /PRNewswire/ -- PriCara(R), Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., said today that one lot of 50 microgram/hour (mcg/hr) DURAGESIC(R) (fentanyl transdermal system) CII patches sold by PriCara in the United States and one lot of 50 mcg/hr fentanyl patches sold by Sandoz Inc. in the United States are being voluntarily recalled as a precaution from wholesalers and pharmacies. The recall is being conducted in cooperation with the U.S. Food and Drug Administration (FDA).

The company has identified a condition in the manufacturing equipment that has since been corrected. The condition resulted in a cut-system defect in a small number of affected patches in the lots being recalled. ALZA Corporation of Mountain View, CA, an affiliate of PriCara, manufactured the patches being recalled. DURAGESIC 50 mcg/hr (fentanyl transdermal system) patches and Sandoz Inc. 50 mcg/hr fentanyl transdermal system patches being recalled may have a cut along one side of the drug reservoir. 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 wash exposed skin with large amounts of water only; do not use soap, alcohol, lotions, oils or other products to remove the medicine gel because they may increase the medicine's ability to go through the skin.

Immediately dispose of 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.

DURAGESIC 50 mcg/hr patches being recalled: lot number 0817239.

Anyone with 50 mcg/hr DURAGESIC patches from this lot should call 800-547-6446.

The Sandoz Inc. 50 mcg/hr patches being recalled: lot number 0816851.

Anyone with 50 mcg/hr Sandoz Inc. patches from this lot should call 800-901-7236.

Anyone who has 50 mcg/hr DURAGESIC or 50 mcg/hr Sandoz Inc. fentanyl patches should check the box or foil pouch to see if they have patches from the recalled lots. Cut patches should not be handled directly.

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

    MEDIA CONTACT:
    Greg Panico
    Office:   (908) 927-3715
    Mobile:   (908) 240-2011


'/>"/>
SOURCE PriCara, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine news :

1. ETHEX Corporation Initiated Nationwide Voluntary Recalls of Specific Lots of Five Generic Products Due to the Potential for Oversized Tablets
2. ETHEX Corporation Voluntarily Recalls Three Lots of Dextroamphetamine Sulfate 5mg Tablets Due to the Potential for Oversized Tablets
3. ETHEX Corporation Voluntarily Recalls a Single Lot of Morphine Sulfate 60 mg Extended Release Tablets Due to the Potential for Oversized Tablets
4. Heart Device Recipients Often Not Aware of Recalls
5. Toxic Stock Syndrome Report: Many Companies Are Keeping Shareholders in the Dark on Potential Recalls, Bans, and Other Risks
6. Baxter Recalls Rest of Heparin Products
7. PriCara(TM) Recalls 25 mcg/hr DURAGESIC(R) (fentanyl transdermal system) CII Pain Patches
8. Fairbank Farms Voluntarily Recalls 85% Ground Round Beef Patties Sold Fresh from Shaws Due to Possible Health Risk
9. Why women should eat less, move more and consider wearing transdermal HRT patches during menopause
10. Watson Announces Limited Recall of Fentanyl Transdermal System
11. Echo Therapeutics and Cato BioVentures Sign Right of First Offer Agreement for Dermatology Products and Transdermal Drug Delivery Technologies
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/26/2017)... Germantown, MD (PRWEB) , ... May 26, 2017 , ... ... the anti-stress Antzy Top gadget will continue to be available at a discounted crowdfunding ... people deal with stress wherever they are, I also wanted to bring a fidget ...
(Date:5/26/2017)... Francisco, CA (PRWEB) , ... May 26, 2017 , ... ... Francisco, is proud to announce a new, informational blog post on insurance options. If ... surgery, checking insurance plans may help save time and money. Visiting an in-network provider ...
(Date:5/26/2017)... ... , ... “Just What Happened in the Garden of Eden”: retells the stories of three Bible ... creation of published author, Penelope Colt, mother, trader, horse farmer, artist and a former GM ... was three. At six, they moved to Dayton, Ohio, where Penny graduated high school. ...
(Date:5/24/2017)... , ... May 24, 2017 , ... ... background. Understanind and choosing the most appropriate instruments for research and understanding the ... research finding. This webinar will focus on innovations in stereo microscopy for brightfield ...
(Date:5/24/2017)... ... May 24, 2017 , ... Drs. Nicholas ... who have now spent 10 years as clinical instructors for the reputable Full ... of Dentistry. Through the program, private practitioners receive cutting-edge clinical training and learn ...
Breaking Medicine News(10 mins):
(Date:5/6/2017)... Texas , May 5, 2017   Provista , ... with more than 200,000 customers, today announced Jim Cunniff ... a wealth of executive and business experience to Provista, including ... compounding pharmacy in California . He assumed ... "Jim is a great fit for Provista," says ...
(Date:5/4/2017)... 2017 Clarius Mobile Health, a digital ... scanners this week at the American Congress of ... San Diego, CA from ... the perfect tool for clinicians to easily confirm ... evaluate pregnancy-related complications like ectopic pregnancy and placenta ...
(Date:5/3/2017)... 2017 A Catheterization Laboratory is an ... facility. Commonly referred to as cath lab, this ... imaging technology to give physicians visual access to ... spaces, a team of physicians perform life-saving procedures ... intervention, congenital heart defect closure, stenotic heart valves, ...
Breaking Medicine Technology: