When it comes to the safe use of synthetic opioids like fentanyl, precise dosing of the powerful pain meds is key. Now, Alvogen is yanking one product in the U.S. thanks to a packaging error that's already yielded at least one major safety report.
Alvogen has issued a voluntary recall on a single lot of fentanyl transdermal patches due to the risk that some of the products could be "multi-stacked" and stuck together in a single pouch.
Patients who apply the stacked pouches run the risk of taking a higher dose than intended, potentially leading to serious, life-threatening or fatal breathing issues, Alvogen warned.
First-time users of the patches, plus children and the elderly, are at greater risk of potential overdose incidents, the company added.
So far, Alvogen says it has already received at least one "serious adverse event" report tied to the mispackaged products.
The patches in question are used to manage severe and persistent pain in opioid-tolerant patients over an extended treatment period.
The recall covers Lot 108319 of the transdermal patches, which were originally slated to expire in April 2027. The batch, containing cartons of five individually wrapped and labeled pouches, was manufactured by Kindeva Drug Delivery and distributed by Alvogen across the country to pharmacies and patients, according to a Jan. 31 press release.
Alvogen is advising patients to immediately remove any patches in use and contact their healthcare providers. Unused patches should be returned to the point of purchase and swapped out for a replacement.
The problem is not new to Alvogen, which recalled two lots of Fentanyl Transdermal System 12 mcg/h transdermal patches in April 2019 after discovering that “a small number of cartons” labeled as 12 mcg/h actually contained 50 mcg/h patches. Those lots were manufactured by 3M Drug Delivery Systems in St. Paul, Minnesota.
Elsewhere, Hikma last summer recalled one batch of acetaminophen injection, a pain med, citing the “potential presence” of a bag labeled dexmedetomidine HCL in the wrong packaging.