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Yet another fentanyl patch recall has been issued after a drug maker discovered that some of their pain patches could release lethal amounts of the powerful painkiller into the user’s bloodstream.
The FDA announced an Actavis Fentanyl Transdermal System recall on Thursday, after the company discovered that a number of the defective patches are releasing fentanyl faster than laboratory settings indicated as safe. If too much fentanyl is delivered, the pain patches could cause patients to suffer excessive sedation, respiratory depression, slow breathing to dangerous levels or temporarily stop breathing. Actavis said it is not aware of any injuries in connection to the defective pain patches.
The recall affects 18 lots of the Actavis Fentanyl Transdermal System 25 mcg/hour C-II patches at the wholesale and retail level. The patches were packaged individually and shipped in boxes of five. The defective patches were manufactured for Actavis by Corium International in Grand Rapids, Michigan.
There is a Control/Lot number on the bottom of each box and on the black and white side of each individual package in the lower left corner. The recalled lot numbers are 30041, 30049 and 30066 with an expiration date of 12/2011; 30096 and 30123 with an expiration date of 01/2012; 30097, 30241, and 30256 with an expiration date of 02/2012; 30257, 30258, 30349 and 30350 with an expiration date of 03/2012; 30391, 30392, 30429, 30430, 30431 and 30517 with an expiration date of 04/2012.
The Actavis fentanyl pain patch is a generic version of the Duragesic patch, which is manufactured by a subsidiary of Johnson & Johnson.
The fentanyl patch is prescribed to patients suffering from chronic, severe pain. It is designed to slowly deliver a dose of the powerful painkiller Fentanyl, which is an opioid that is considered 100 times more powerful than heroine. If too much of the medication is delivered or if the fentanyl gel contained in the patch comes in direct contact with the skin, it can cause a fatal fentanyl patch overdose.
Since the Duragesic patch was first introduced by Johnson & Johnson in 1994, there have been a number of reported problems with fentanyl pain patches due to manufacturing issues. At least seven different recalls of fentanyl patch systems have been issued by Johnson & Johnson and companies manufacturing generic versions of the patch, raising questions about whether the powerful painkiller can be safely made.
Hundreds of fentanyl pain patch overdose deaths have been associated with different versions of the patch, and dozens of fentanyl patch wrongful death lawsuits have been filed against the various manufacturers.
Actavis has asked all wholesalers and retailers to return the product they have in stock. Any adverse reactions should be reported to FDA’s MedWatch program at www.fda.gov/medwatch/report.htm.