**Due to an update in May 2019 to the FDA.gov website, provided links may not appropriately redirect. Please visit www.fda.gov/drugs/drug-safety-and-availability to see the most recent FDA Medication Safety Alerts and Safety Communications or to search for specific alerts or communications.**
Novo Nordisk recalled 6 batches of NovoPen Echo® insulin delivery devices which were distributed between 8/1/2016 and 6/22/2017. Affected batches include EVG1226, FVG7149, FVG7458, FVG8134, FVG8135, and EVG1221. The device cartridge may break or crack if exposed to chemicals or cleaning agents. This may decrease insulin delivery which could cause hyperglycemia. There have been reports of adverse events and complaints regarding the damaged cartridge holders. NovoPen Echo® is used for insulin treatment in diabetes patients.
Novo Nordisk will replace affected devices. Call Novo Nordisk at 1-855-419-8827 for a replacement cartridge holder if using a NovoPen Echo® from one of the affected batches. Until a new cartridge holder is received, check blood sugar levels frequently and monitor for hyperglycemia. If hyperglycemia occurs, contact a health care provider. Report any adverse events to the FDA MedWatch Adverse Event Reporting Program. Devices from other batches are not affected and can be used with confidence.
Additional information is available at the following links:
- MedWatch Safety Alert – July 6, 2017
www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm565955.htm - Novo Nordisk. Press Release – July 5, 2017
www.fda.gov/Safety/Recalls/ucm565936.htm