On Friday, June 28th, Novo Nordisk sent a letter to NBDF sharing more information about the current product issue related to NovoSeven® RT and Novoeight ®. The letter is in response to questions that NBDF asked Novo to better understand the cause of this product issue, the potential impact on patients in the United States, and how Novo plans to address it. NBDF appreciates this additional information, and we will continue to work together with our global partners to raise additional questions and concerns as needed.
NBDF has pledged to regularly update the community as more information becomes available and will continue to do so as this situation evolves. We appreciate Novo Nordisk’s responsiveness to this issue and their commitment to our community.
Please contact your HTC if you have concerns about your treatment regimen and availability. You can also contact Novo Care customer support at 1-844-668-6732.
June 14, 2024
NBDF has learned about a product issue with NovoSeven® RT and Novoeight®. This is not a product recall, instead there is a concern about the manufacturing process. This manufacturing issue has led to a temporary shortage of the NovoSeven® RT 1 mg and 2 mg vials and some strengths of Novoeight® at the Novo Nordisk Distribution Center (NNDC).
We have not yet received more information about affected lot numbers. NBDF and our global partners are seeking additional information about lot numbers, where the product has been distributed, and how Novo has communicated with the community and providers. We will be officially sharing our concerns with Novo and will share their response publicly.
Please reach out to your HTC if you have concerns about your treatment regimen and availability. If you would like to contact Novo directly, please call the Novo product inquiry line at 1-800-727-6500.
This is only the first step in what we expect to be continuing communications with Novo and the FDA about this event.