Alvogen, Inc. has issued a voluntary nationwide recall on some transdermal fentanyl patches due to faulty product labeling, according to the FDA.
Two lots of patches are being recalled:
Lot 180060 of Fentanyl Transdermal System, 12 mcg/h, expiration date 05/2020, and
Lot 180073 of Fentanyl Transdermal System, 12 mcg/h, expiration date 06/2020.
Alvogen notes that “a small number of cartons” labeled as containing 12 mcg/h patches actually contain 50 mcg/h patches, which are individually labeled as having the 50 mcg/h dose.
"Application of a 50 mcg/h patch instead of a prescribed 12 mcg/h patch could result in serious, life threatening, or fatal respiratory depression," Alvogen said in a press release posted by the FDA. “Groups at potential increased risk could include first time recipients of such patches, children, and the elderly. To date, Alvogen Inc. has not received any reports of adverse events related to this issue.”
Questions about the recall should be directed to Alvogen Customer Complaints at 866-770-3024 from Monday to Friday from 9:00 am to 5:00 pm EST. or by email at pharmacovigilance@alvogen.com.
The patches are intended to be used for the management of pain in opioid-tolerant patients.
