- Danish drugmaker Novo Nordisk announced Wednesday it would recall six batches of faulty insulin cartirdge holders used in its NovoPen insulin delivery device due to the potential for the holders to crack or break when exposed to certain chemicals such as cleaning agents.
- Using a NovoPen device with a damaged holder could result in delivery of a reduced dose of insulin, Novo said in a statement on the recall.
- The six affected batches were distributed between August 2016 and June 22 of this year to distributors, sales representatives and replacement programs. Novo said it would replace the affected cartridges.
Novo Nordisk, one of the top diabetes drugmakers, launched the NovoPen Echo stateside back in 2014. At the time, Novo touted the pen as the first insulin delivery device with half-unit dosing and memory function to be available in the U.S. market.
Prior to initiating the recall, Novo said it had received "numerous complaints" of cracked or broken cartridge holders, including "some reports" of adverse events.
Still, Novo believes the risk of experiencing high blood sugar due to delivery of a reduced insulin dose from a damaged device to be low.
While the company did not specify how the problem occurred, it said the issue has already been corrected.
Affected batch numbers include EVG1221, EVG1226, FVG7149, FVG7458, FVG8134, and FVG8135. Patients who have used a damaged pen are recommended to check blood sugar levels more frequently than usual.
Distributors, pharmacies, healthcare professionals and patients will be notified by mail, Novo said.
Last September, Novo recalled six batches of its Glucagen Hypokit after complaints of detached needles on the product syringe.