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Actavis Inc. has expanded its recent recall of fentanyl painkiller patches to include all lots sold in the United States. The company said the expansion is a precautionary measure because it cannot guarantee that all patches are without defect.

Overdose Risk

On February 17, 2008, Actavis recalled 14 lots of its fentanyl transdermal patches over concerns of a possible fold-over defect that could cause the medication to leak. Direct exposure to fentanyl gel could result in respiratory problems and potentially fatal overdose.

Fentanyl is an extremely powerful narcotic, as much as 80 times stronger than morphine. Patches containing fentanyl have been tied to a high rate of accidental overdose, and there have been several recalls involving Duragesic brand fentanyl patches in recent years.

Patient Information

Recalled Actavis patches should be disposed of immediately. Anyone in possession of a potentially defective patch should flush it down the toilet, being careful not to handle the patch directly.

Patients should note that some of the fentanyl containing pouches may bear the name of Abrika Pharmaceuticals, the former name of Actavis Inc.

Any adverse events associated with use of Actavis fentanyl patches should be reported to the Food and Drug Administration. If overdose is suspected, patients should contact their physician immediately.

(Source: FDA website)

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