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Medication Recall -- PRICARA™ RECALLS 25 mcg/hr DURAGESIC® Pain Patches

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Donnachaidh Donating Member (1000+ posts) Send PM | Profile | Ignore Sat Mar-15-08 12:12 AM
Original message
Medication Recall -- PRICARA™ RECALLS 25 mcg/hr DURAGESIC® Pain Patches
My apologies if this is a repeat. Some here are on pain management programs, and this is a drug used by some on longterm pain management programs.

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.

Contact and more information at http://www.fda.gov/oc/po/firmrecalls/pricara02_08.html

and here -- http://www.duragesic.com/duragesic /

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FirstLight Donating Member (1000+ posts) Send PM | Profile | Ignore Sat Mar-15-08 12:36 AM
Response to Original message
1. Wait a minute...
Edited on Sat Mar-15-08 12:36 AM by Journalgrrl
"Immediately dispose of affected patches with cut edges by flushing them down the toilet, using caution not to handle them directly. "

sooo, what does that mean to the environment? shouldn't they be taken to the pharmacy for proper disposal?
that seems WRONG in SO many ways to tell someone not to touch something,

But just " flush it away, and it will all go bye-bye..."
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Donnachaidh Donating Member (1000+ posts) Send PM | Profile | Ignore Sat Mar-15-08 11:27 AM
Response to Reply #1
2. that's the irony of it
I'm a user of this stuff. Been in a longterm pain program and these were only recently added, because I wanted to go down on the amount of drugs used daily.

I was taken aback when my doctor was VERY precise about HOW I should physically handle this stuff when applying it. And my pharmacist just about had a shit hemmorhage when I had it filled.

It was posted not too long ago that we are finding prescription drugs in the water supply. And the docs always tell us to flush this stuff!

What REALLY freaked me out is the FACT that my last doctor visit was 3 DAYS after this recall, yet the doctor prescribed it AGAIN, and the pharmacist said nothing about the recall EITHER. That was my main reason for posting the notice.

I'm bagging the stuff in plastic, and waiting till Monday to call the doctor and find out where and how I can get rid of this shit safely. :grr:
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