News

US-based pharmaceutical company Alvogen has issued a voluntary recall of one batch of its Fentanyl Transdermal System 25mcg/h transdermal patches, amid concerns that patches could be multi-stacked in a single product pouch.

The application of a multi-stacked 25mcg/h patch could result in life-threatening or fatal respiratory depression, particularly in vulnerable groups such as children or the elderly. The patches are used for the management of severe and persistent pain in opioid-tolerant patients who require an extended treatment period with a daily opioid analgesic, for which alternative treatments are inadequate.

Alvogen is notifying its distributors and direct customers by certified letter, and is arranging for the return and replacement of recalled products. The recall is being conducted with the knowledge of the US Food and Drug Administration (FDA). Alvogen has recieved one serious adverse event which is related to the recall.