Actavis recalls certain Fentanyl patches in the US as precaution
Official Actavis Press
Release
February 17, 2008
Source:
http://www.actavis.com/en/media+center/newsroom/articles/fentanyl+recall+us.htm
Actavis Inc., the United States manufacturing and marketing division of
Actavis Group, today announced that 14 lots of Fentanyl transdermal system
CII patches sold in the United States by Actavis’ subsidiary Actavis
South Atlantic LLC are being voluntarily recalled from wholesalers and pharmacies
as a precaution.
The recalled patches were manufactured by Corium
International Inc., a contract manufacturer for Actavis.
The recall is being conducted in
cooperation with the US Food and Drug Administration. Fentanyl patches sold
by Actavis in Europe are not affected by this recall.
The 14 lots of Fentanyl
transdermal system patches being recalled may have a fold-over defect which
has the potential to cause the patch to leak fentanyl gel, therefore, as
a precaution, Actavis is recalling these lots. As per the approved product
labelling for Fentanyl transdermal system, fentanyl is a potent Schedule
II opioid medication. Fentanyl patches that are leaking 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 that may be damaged or compromised in any way
by flushing them down the toilet, using caution not to handle them directly.
Damaged and/or compromised patches that have leaked gel will not provide
effective pain relief.
Anyone who has Actavis Fentanyl patches should check
the box for the following lot number and expiration date to see if they have
patches that are being recalled.
The affected lots are:
Lot no Strength Exp Date
27261 25 mcg/hr 5/09
27391 25 mcg/hr 6/09
27488 25 mcg/hr 6/09
27317 50 mcg/hr 5/09
27475 50 mcg/hr 6/09
27514 50 mcg/hr 7/09
27536 50 mcg/hr 7/09
27538 50 mcg/hr 8/09
27318 75 mcg/hr 5/09
27409 75 mcg/hr 6/09
27476 75 mcg/hr 6/09
27537 75 mcg/hr 8/09
27319 100 mcg/hr 5/09
27545 100 mcg/hr 7/09
Actavis South Atlantic LLC was formerly known as Abrika
Pharmaceuticals Inc. The patches are double-branded, with Abrika on the pouch
and Actavis on the box.
Affected patches should not be handled directly.
Anyone with Actavis Fentanyl
transdermal system patches with the above listed lot numbers should call
1 877 422 7452.
Patients using fentanyl patches who have medical questions
should contact their health-care providers.
Fentanyl transdermal system is
indicated for the management of persistent, moderate to severe chronic pain
that requires continuous, around the clock opioid administration for an extended
period of time and cannot be managed by other means such as non-steroidal
analgesics, opioid combination products, or immediate release opioids
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