A small number of NovoPen Echo devices may crack or break if exposed to certain chemicals.
Novo Nordisk announced on July 5 that it is initiating a recall of cartridge holders used in a small number of its NovoPen Echo insulin delivery devices because they may crack or break if exposed to certain chemicals, leading to a reduced amount of insulin delivered.
According to a statement, Novo Nordisk believes that the risk of a patient using a device with an affected cartridge holder experiencing high blood sugar “is low.” However, the company cautioned, patients using an affected pen may want to check their blood sugar levels more frequently until they receive a new cartridge holder, and contact their healthcare provider if they believe they’re experiencing an episode of hyperglycemia.
The affected cartridges were distributed between August 1, 2016, and June 22, 2017 to several channels that further distributed them to pharmacies, healthcare providers, and patients nationwide. Novo Nordisk is in the process of notifying these channels and end-users by mail and arranging for their replacement.
In total, 6 batches were affected (all with US batch numbers): EVG1221, EVG1226, FVG7149, FVG7458, FVG8134, and FVG8135.
The company also advised that there is no reason for concern if patients are in possession of an insulin delivery device with a batch number that is not included in this recall, and that those patients can be confident that their pens will work as intended.
The recall was issued after the company received complaints of damaged cartridge holders as well as some reports of adverse events. The company says that it has corrected the problem and determined that no other component of the pen is affected.
“Novo Nordisk is committed to delivering high-quality products and sincerely apologizes to patients and healthcare professionals,” the company-issued statement read. “We are working closely with the US Food and Drug Administration [FDA] to ensure patient safety and further minimize disruption.”
Patients in the United States who are using a device from an affected batch are instructed to call Novo Nordisk at 855-419-8827 between 8:00 am and 6:00 pm EDT to order their replacement cartridge holder. For questions about the recall, patients and healthcare providers are asked to call 855-419-8827; for general questions or concerns, contact Novo Nordisk Customer Care 800-727-6500, Monday through Friday, between 8:30 am and 6:00 pm EDT.
Adverse reactions or other quality problems experienced with the use the affect product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, or by fax to 800-FDA-0178.