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Actavis Fentanyl Pain Patches Recalled

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Drugmaker Actavis Inc. is recalling 18 lots of its Fentanyl Transdermal System 25 mcg/hour C-II patches. According to the recall notice, the Fentanyl pain patches may release active ingredient faster than the approved specification. This could lead to adverse events for at-risk patients, including excessive sedation, respiratory depression, hypoventilation (slow breathing), and apnea (temporary suspension of breathing). According to the recall notice, Actavis identified one lot of 25 mcg/hour Fentanyl patches shipped to market that contained one patch that released its active ingredient faster than the approved specification in laboratory testing. The company has characterized this recall as a precautionary measure. Under this recall, all wholesalers and retailers are being asked to return the product they have on hand or in stock. The recalled patches are packaged individually and boxed in quantities of five patches per box. A complete list of the Control/Lot numbers involved in this recall can be accessed here. Fentanyl Transdermal System patches are indicated for the management of persistent, moderate

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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. So far, no injuries have been associated with the recalled fentanyl patches.

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