The Duragesic CII patch, also knows as fentanyl transdermal system, is a strong medication for moderate-to-severe chronic pain, available only by prescription, which can provide long-lasting relief from persistent pain. It is an opioid pain medication that slowly seeps into the body through the skin where it works to relieve pain for up to 72 hours.
In February of 2004, Janssen Pharmaceutical Products, L.P., the maker of the drug and a subsidiary of Johnson & Johnson, recalled one lot of the 75 mcg per hour patches because of reports of leaks in the packaging, causing the fentanyl to seep into a person's skin at an uncontrolled rate.
In April of 2004, the recall was expanded to include 4 more lot numbers of the same 75 mcg per hour patches.
Results of the leaking patches may lead to life-threatening injuries, with one lawsuit being filed in April 2004 stating that the defective Duragesic patches were the cause of death.
The FDA approved Duragesic in 1990.
Related Litigation Content
- Family Files $25 Million Lawsuit over Drug Patch - Apr 21 2004
- Janssen Pharmaceutica Expands Nationwide Recall of 75 mcg/Hour Duragesic® (Fentanyl Transdermal System) CII Patches - Apr 05 2004
- U.S. Food and Drug Administration Applies Duragesic Six-Month Period of Pediatric Exclusivity - Jan 22 2004