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
From http://www.jnj.com/news/jnj_news/20080212_145928.htm
February 12, 2008
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 call800-901-7236.
Patients
using fentanyl patches who have medical questions should contact their
health-care providers.
For more information, visit 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™ patches sold in Europe,
Latin America and Asia are not affected by this recall
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