Novo Nordisk recalls insulin delivery device

Novo Nordisk has initiated a recall of insulin cartridge holders used in a small number of NovoPen Echo batches because they may crack or break if exposed to certain chemicals, such as certain cleaning agents, the FDA announced in a press release.

NovoPen Echo is used for insulin treatment by people with diabetes. Using a device with a cracked/broken cartridge holder may result in the device delivering a reduced dose of insulin, which could potentially lead to hyperglycemia. Novo Nordisk believes the risk of experiencing high blood sugar when using a device with an affected cartridge holder is low, according to the release, but the company is encouraging patients using an affected pen to check their blood glucose level more frequently until receiving a new cartridge holder. Patients should contact their health care provider if they believe they are experiencing hyperglycemia.

The affected batches were distributed between Aug. 1, 2016, and June 22, 2017, to distributors, sales representatives and replacement programs for further distribution to pharmacies, health care providers and patients nationwide. Novo Nordisk is notifying distributors, pharmacies, health care professionals and patients by mail and is arranging for product replacement.

Replacement cartridge holders will be provided for NovoPen Echo with the following U.S. batch numbers:

EVG1221
EVG1226
FVG7149
FVG7458
FVG8134
FVG8135

Novo Nordisk has received numerous complaints of damaged cartridge holders and has received some reports of adverse events to date, according to the release. Novo Nordisk has corrected this problem and has determined that no other component of the pen is affected.

In the United States, people 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.

For questions specific to the recall, call 1-855-419-8827.