Alvogen’s fentanyl transdermal system is sold at five different strengths, and an error saw products containing 50mcg/h patches labelled as 12mcg/h. The lots were distributed in the US to the pharmacy level.
According to the company, the application of a 50mcg/h patch instead of the prescribed 12mcg/h patch could result in serious, life-threatening or fatal respiratory depression.
At particular risk are those patients who could be the first-time recipients of such a treatment, such as children and the elderly.
Alongside the US Food and Drug Administration (FDA), Alvogen has initiated a nationwide, voluntary recall of the two separate lots that are affected.
The treatment is indicated for use in the management of pain in opioid-tolerant patients, with the patches delivering consistent levels of fentanyl, a powerful synthetic opioid that is similar to morphine but can be 50 to 100 times more potent.
3M manufactures the transdermal technology for Alvogen, and the former company issued a release linking to the latter’s statement on the recall.
Alvogen stated that no patients have reported adverse events as a result of the mislabelling, and it would be notifying distributors and direct customers by certified letter regarding the recall.
However, the FDA has previously come under criticism for the manner in which it has tried to regulate the market for fentanyl pain patches.