Last month, Actavis, an Iceland-based pharmaceutical company specializing in generic drugs, issued a voluntary recall to wholesale and retail level distributors of 18 lots of Fentanyl Transdermal System 25 mcg/hour C-II patches. The patches are indicated for the management of persistent, moderate to severe chronic pain that requires continuous opioid administration for an extended time period. The drug is used in patients in whom other means of pain management, such as nonsteroidal analgesics, opioid combination products, or immediate release opioids, are ineffective. The drug is highly addictive and is 80 times more potent than morphine. In the U.S., the Fentanyl Transdermal System is manufactured for Actavis by Corium International, headquartered in San Mateo, CA.
Actavis identified one lot of 25 mcg/hour Fentanyl patch (Control/Lot # 30349) shipped to market that contained one patch that released its active ingredient faster than the approved specification in laboratory testing. An accelerated release of Fentanyl from a 25 mcg/hour patch can lead to adverse events for at-risk patients, including excessive sedation, respiratory depression, hypoventilation (slow breathing), and apnea (temporary suspension of breathing). The patches are packaged individually and boxed in quantities of five patches per box.
Read the entire release and the list of recalled lots
Source: Actavis Inc., press release dated October 21, 2010