Actavis recalls certain Fentanyl patches in the US as precaution

Actavis recalls certain Fentanyl patches in the US as precaution

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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