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February 22, 2008: Actavis Announces U.S. Fentanyl Patch Recall

Actavis Fentanyl Patch Recall News – On February 17, 2008, Actavis, Inc., U.S., issued a recall for 14 lots of Fentanyl Transdermal System CII patches due to a possible fold-over defect which may cause the patch to leak, thus exposing patients or caregivers directly to the fentanyl gel.

Fentanyl is a potent opioid analgesic (pain killer), with approximately 80 times the potency of morphine. The fentanyl transdermal patch is used for the management of persistent, moderate to severe chronic pain that requires continuous opioid administration for an extended period of time. Fentanyl patches are prescribed when pain cannot be managed by other means such as non-steroidal analgesics, opioid combination products, or immediate release opioids.

Actavis Fentanyl Patch Recall Information

The company cautions healthcare providers and consumers of the following:

The 14 lots of Fentanyl transdermal system patches being recalled may have a fold-over defect which may cause the patch to leak and expose patients or caregivers directly to the fentanyl gel. Although unaware of any injuries resulting from this issue Actavis, as a precaution, 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.

The lots covered by this recall are: 27261 (exp 05/09), 27317 (exp 05/09), 27318 (exp 06/09), 27319 (exp 06/09), 27391 (exp 06/09), 27409 (exp 06/09), 27475 (exp 07/09), 27476 (exp 06/09), 27488 (exp 06/09), 27514 (exp 07/09), 27536 (exp 07/09), 27537 (exp 08/09), 27538 (exp 08/09), 27545 (exp 07/09), covering the following strengths: 25 mcg/hr, 50 mcg/hr, 75 mcg/hr and 100 mcg/hr.

Please note: Actavis South Atlantic LLC was formerly known as Abrika Pharmaceuticals Inc. The pouches containing the patches are 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.

Anyone who has fentanyl patches labeled with an Abrika or Actavis label should check them for these lot numbers.

Affected patches should not be handled directly.

As always, if you have any questions concerning your health, or prescribed medications it is important to contact your healthcare provider.

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