Novo Nordisk has voluntarily recalled insulin cartridge holders used in six NovoPen Echo batches because they may crack or break if exposed to certain chemicals, like certain cleaning agents.
Using a device with a cracked/broken cartridge holder may cause the insulin pen to deliver a reduced dose of insulin which could potentially lead to high blood sugar. Novo Nordisk said the risk of such an occurrence is low.
The affected batches were distributed between August 1, 2016 and June 2, 2017 to distributors, sales representatives and replacement programs for further distribution to pharmacies, healthcare providers and patients nationwide. Novo Nordisk is notifying these entities by mail and is arranging for product replacement.
Replacement cartridge holders will be provided for NovoPen Echo with the following U.S. batch numbers:
Novo Nordisk has received numerous complaints of damaged cartridge holders and has received some reports of adverse events to date, according to their press release. They said they have corrected this problem and have determined that no other component of the pen is affected.
Patients with diabetes using a NovoPen Echo from one of the affected batches listed above should call Novo Nordisk at 1-855-419-8827 between 8 a.m. and 6 p.m. Eastern time to get a replacement cartridge holder.
Novo Nordisk encourages patients with an affected device to check their blood sugar levels more often than usual until receiving a new cartridge holder.