Recall: Insulin Pen Devices with Damaged Cartridge Holders ID'd
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 cleaning agents. NovoPen Echo is an insulin pen device used with NovoLog (insulin aspart [rDNA origin]) PenFill cartridges for the treatment of diabetes.
At this time, Novo Nordisk has received several complaints of damaged cartridge holders and some reports of adverse events. Using a device with a cracked or broken cartridge holder may result in the device delivering a reduced dose of insulin.
Replacement cartridge holders will be provided to patients affected by this recall. The affected batches were distributed between 8/1/2016 – 6/22/2017 and have the following batch numbers: EVG1221, EVG1226, FVG7149, FVG7458, FVG8134, FVG8135.
The company reports that the problem has been corrected and has determined that no other component of the pen is affected. Adverse reactions related to this recall may also be reported to the FDA's MedWatch Adverse Event Reporting program.
For more information call (855) 419-8827 or visit NovoNordisk-us.com.