Actavis Recalls Remaining Fentanyl Patches in
the US as Precaution
FDA Post of Official
Actavis Press Release
March 2 , 2008
Source:
http://www.fda.gov/oc/po/firmrecalls/actavis03_08.html
Contact:
Sarita Thapar, PharmD
908-659-2471
FOR IMMEDIATE RELEASE -- Morristown, NJ, March 1, 2008 -- Actavis
Inc., the United States manufacturing and marketing division of the international
generic pharmaceutical company Actavis Group hf, today announced that its
subsidiary Actavis South Atlantic LLC is proceeding with the voluntarily
recall from wholesalers and pharmacies of all lots of Fentanyl
transdermal system CII patches sold in the United States.
This recall is an expansion
of the Company's initial recall
of fourteen lots of Fentanyl transdermal patches announced on February 17,
2008. That recall was due to the identification
of a possible fold-over defect present in the product that potentially could
cause leakage of the fentanyl gel. The remaining lots of Fentanyl transdermal
system patches are being recalled as a precautionary measure because Actavis
lacks assurance that all patches are free from defects.
All of the recalled patches were manufactured by Corium
International Inc., a contract manufacturer for Actavis, and sold nationwide
in the United States.
Fentanyl
patches sold by Actavis in Europe are not affected by this recall.
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.
Please note: Actavis South
Atlantic LLC was formerly known as Abrika Pharmaceuticals Inc. The pouches
containing the patches may be labelled with an Abrika Pharmaceuticals label,
but the outer carton bears the Actavis logo with the following product names:
Actavis Fentanyl Transdermal System, 25 mcg/hr. NDC 67767-120-18.
Actavis Fentanyl Transdermal System, 50 mcg/hr. NDC 67767-121-18.
Actavis Fentanyl Transdermal System, 75 mcg/hr. NDC 67767-122-18.
Actavis Fentanyl Transdermal System, 100 mcg/hr. NDC 67767-123-18.
The lots
covered by this recall have expiration dates between May 2009 and December
2009. Anyone who has fentanyl patches labelled with an Abrika or Actavis
label should check them for these expiration dates.
Anyone with Actavis
Fentanyl transdermal system patches with the lot numbers listed on the schedule,
should call 1 877 422 7452.
Patients using fentanyl
patches who have medical questions should contact their health-care providers.
This recall is being conducted with the knowledge
of the Food and Drug Administration.
Any
adverse reactions experienced with the use of this product, and/or quality
problems should also be reported to the FDA's MedWatch Program by phone at
1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600
Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch
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