Alvogen announced that it is voluntarily recalling two of its Fentanyl Transdermal System 12 mcg/h transdermal patches to the consumer level because of a labeling issue.
The company says that a small number of cartons that were labeled as 12 mcg/h Fentanyl Transdermal System patches actually had 50 mcg/h patches. The 50 mcg/h patches in the cartons were labeled as such. The transdermal system is made by 3M Drug Delivery Systems.
If a higher dose of the Fentanyl Transdermal System is used instead of the 12 mcg/h patch, it could result in more serious, life-threatening or fatal respiratory depression. First time recipients, children and the elderly are most at risk. Alvogen has so far not received any reports of adverse effects because of the mislabeling.