Alvogen, Inc. recalled one lot of Fentanyl Transdermal System (25 mcg/h) patches due to a risk of respiratory depression or death.
There is a risk that these Fentanyl Transdermal System patches could be multi-stacked on top of each other, with multiple patches stuck one on top of the other, in a single product pouch.
Alvogen reported “one serious adverse event related to this recall.”
These multi-stacked patches could deliver a higher dose of fentanyl. High-risk groups include first-time recipients of such patches, children, and the elderly.
No deaths were reported, but people who use a multi-stacked 25 mcg/h patch could suffer “serious, life-threatening, or fatal respiratory depression,” according to the recall announcement.
The recall involves Lot 108319 of Fentanyl Transdermal System, 25 mcg/h, expiration date 04/2027.
This lot was distributed nationwide to pharmacies and patients.
Alvogen is asking pharmacies not to dispense any products subject to recall. Patients who have this product should “immediately remove any patch currently in use and contact their health care provider.”
