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Actavis Recalls More Fentanyl Pain Patches

Mar 3, 2008 | Parker Waichman LLP

More Fentanyl Pain Patches have been recalled by Actavis Inc due to a possible defect that could cause fentanyl to leak from the Actavis pain patches.  Actavis had recalled 14 lots of the Fentanyl Pain Patches in  mid-February.  Actavis said the remaining lots of the fentanyl transdermal system patches are being recalled as a precautionary measure because the company lacks insurance that all patches are free from defects

Fentanyl transdermal patches are 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 that cannot be managed by other means.  The first Actavis Fentanyl Pain Patch recall followed a decision by  Johnson & Johnson to recall its 25-microgram-per-hour Duragesic Pain Patches that are sold in the U.S. by J&J’s PriCara unit and Sandoz; they are made by another J&J unit, Alza Corp.  The defective Duragesic patches had a sliced edge in the pouch that contains the fentanyl gel, which could result in the gel leaking. The 25-microgram-per-hour patches are prescribed mainly for lower-weight patients, children and patients just starting on the medicine.

On February 17, Actavis recalled 14 lots of its Fentanyl Pain Patch as a "precaution". Now Actavis is recalling remaining lots of its Fentanyl Pain Patch.  All of the recalled patches were manufactured by Corium International Inc., a contract manufacturer for Actavis, and sold nationwide in the United States.  The lots covered by this recall have expiration dates between May 2009 and December 2009. Anyone who has fentanyl patches labeled with an Abrika or Actavis label should check them for these expiration dates. Actavis South Atlantic LLC was formerly known as Abrika Pharmaceuticals Inc. The pouches containing the patches may be labeled 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.

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 with Actavis Fentanyl transdermal system patches with the lot numbers listed on the schedule, should call 1 877 422 7452.

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