Novo Nordisk (NYSE:NVO) launched a recall yesterday of insulin cartridge holders used in select batches of NovoPen Echo insulin delivery devices. The company said the cartridge holders could crack or break upon exposure to certain chemicals.
Using a NovoPen Echo with a cracked or broken cartridge holder could result in the device delivering a lower dose of insulin than the user intended.
The company said it “believes the risk of experiencing high blood sugar when using a device with an affected cartridge holder is low.”
The affected batches were distributed between August 1, 2016 and June 22, 2017 and include U.S. batch numbers EVG1221, EVG1226, FVG7149, FVG7458, FVG8134 and FVG8135.
Nordisk said that anyone with a device from the affected batches should contact the company for a replacement cartridge holder. Nordisk has received a number of complaints related to the damaged cartridge holders and has also received some reports of adverse events, according to the company.
“Novo Nordisk is committed to delivering high-quality products and sincerely apologizes to patients and health care professionals,” the company wrote in a statement. “We are working closely with the U.S Food and Drug Administration to ensure patient safety and further minimize disruption.”