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Fentanyl Duragesic/Transdermal Pain Patch Recall

Recalled Duragesic Fentanyl PatchDuragesic is a pain patch that is worn on the skin as a topical treatment for chronic pain. The Duragesic patch contains a narcotic analgesic called fentanyl. The Duragesic patch allows medicine to be absorbed slowly through the skin at a constant rate for up to three days. The patches come in different strengths, and more than one patch may be worn at a time.

Over the past several months the FDA and several manufacturers have issued a recall of Fentanyl patches. The recall was issued when it was discovered that some patches were defective and leaking the powerful Fentanyl gel from the patch. This type of direct exposure to a normally time released concentration of Fentanyl can easily cause respiratory depression and even death.

RECALL INFORMATION:

February 12, 2008

PRICARA™ RECALLS 25 mcg/hr DURAGESIC® (fentanyl transdermal system) CII PAIN PATCHES

25 mcg/hr DURAGESIC Patches

25 mcg/hr Sandoz Inc. Patches

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February 17, 2008

Actavis Recalls Certain Fentanyl Patches in the US as Precaution

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.

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March 1, 2008

Actavis Recalls Remaining Fentanyl Patches in the US as Precaution

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.

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August 8, 2008

Watson Announces Limited Recall Of Fentanyl Patches

Single Lot Recalled:

Lot Number 92461850

Expiration dates of August 31, 2009