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
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.
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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