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