Novo Nordisk has announced a recall of six batches of the insulin cartridge holders used in its NovoPen Echos due to the possibility they will crack or break when exposed to certain chemicals. The company revealed some cleaning agents may contain agents that could leave the device susceptible to breakages or cracking.
The NovoPen Echo is used to deliver insulin to patients with diabetes and is the first and only pens featuring a memory function and the capacity to administer half-unit dosing. It records the dose and time since the last injection, and has a dose button to help patients administer the right quantity of insulin without wastage.
Affected NovoPens may deliver a reduced dose of insulin, which puts patients at risk of experiencing high blood sugar. Novo Nordisk has stated this risk is low, but has notified distributors, pharmacies, healthcare professionals and patients about the affected products and how they can arrange replacements.
Patients in possession of NovoPens from the batches listed below have been advised to check their blood sugar more regularly as a precautionary measure until they receive a new cartridge holder. According to Novo Nordisk, there have been a number of reports of damaged cartridge holders and some reports of adverse events. Patients may report adverse reactions and quality issues to the US Food and Drug Administration's (FDA's) MedWatch Adverse Event Reporting program online, or by mail or fax.
Signs of hyperglycemia
There are a number of warning signs of hyperglycemia that patients should be aware of. If you are diabetic and are concerned you are exhibiting these symptoms, you should consult with a healthcare professional. Signs of the condition usually appear gradually and may include:
- Flushed, dry skin
- Feeling sleepy or tired
- Dry mouth
- Fruity or acetone breath
- More frequent urination
- Feeling soft thirst
- Loss of appetite
- Feeling or being sick, (nausea or vomiting)
Which U.S. batches are affected?
What to do if you are in possession of an affected device?
Patients who use a NovoPen Echo that is from one of the batches listed above do not need to replace or send back their devices. However, patients with an affected product have been advised to call Novo Nordisk at 1-855-419-8827 between 8 am and 6 pm EDT for a replacement cartridge holder.
Any other questions related to the recall of the cartridges can be directed to 1-855-419-8827, while any other general questions or concerns can be addressed by Novo Nordisk Customer Care at 1-800-727-6500, Monday-Friday, 8:30 am – 6 pm EDT.
Novo Nordisk stated it was working closely with the FDA to ensure patient safety and minimize any further disruption. It has also taken steps to correct the problem that led to the recall and has reassured patients there are no other problems with the device.