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.
The drug has become a part of the developing opioid epidemic in the US, which the FDA is taking increasing action to curb from a drug safety and approval stance.
However, the FDA has previously come under criticism for the manner in which it has tried to regulate the market for fentanyl pain patches.
