Fentanyl Transdermal Patches Recalled Due to Product Mislabeling

Two lots have been recalled by Alvogen because the strength on the carton does not match that of the patches within the box.

Alvogen has announced a recall of 2 lots of Fentanyl Transdermal System 12mcg/h transdermal patches as the cartons, while labeled as 12mcg/h, actually contain 50mcg/h patches. The patches within the carton are individually labeled as 50mcg/h.

Fentanyl Transdermal System is indicated for the management of pain in opioid tolerant patients, severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

The products affected by this recall include:

    Lot 180060 of Fentanyl Transdermal System, 12 mcg/h, expiration date 05/2020

    Lot 180073 of Fentanyl Transdermal System, 12 mcg/h, expiration date 06/2020

The underside of one of the recalled lot’s packages. Credit: Alvogen.

While adverse events related to this recall have not been reported to date, the Company is alerting the public that the use of a higher strength patches could potentially lead to serious, life-threatening, or fatal respiratory depression, particularly for first-time users of fentanyl patches or elderly patients.

Related Articles

Patients in possession of the recalled product should return it to the point of purchase for replacement.

For more information call (866) 770-3024 or visit alvogen.com.