Two lots of Duragesic pain patches were recalled on December 31, 2008 by the Pri-Cara division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., which is a unit of Johnson & Johnson. The reason given was that cuts in the product might allow direct exposure to the fentanyl gel, which is a very powerful opioid. That exposure can cause a potentially fatal overdose.

There is a long history of recalls and of Public Health Advisories from the FDA regarding fentanyl pain patches. Millions of pain patches have been recalled. Manufacturers include Alza, Sandoz, Janssen, Mylan, Watson and Actavis. Actavis patches also involve the names of Corium International and Abrika Pharmaceuticals. The FDA has received hundreds of reports of fatalities associated with fentanyl patch use. Millions of dollars in jury verdicts have been awarded.

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