On July 5, 2017, Novo Nordisk recalled insulin cartridge holders used in NovoPen Echo batches because they may crack or break if exposed to certain chemicals, like certain cleaning agents. Novo Nordisk has received numerous complaints of damaged cartridge holders and has received some reports of adverse events to date.
NovoPen Echo is used for insulin treatment by people with diabetes. Using a device with a cracked/broken cartridge holder may result in the device delivering a reduced dose of insulin, which could potentially lead to high blood sugar. Novo Nordisk believes the risk of experiencing high blood sugar when using a device with an affected cartridge holder is low.
The warning signs of high blood sugar (also known as hyperglycemia) typically appear gradually and might include flushed, dry skin; feeling sleepy or tired; dry mouth, fruity (acetone) breath; urinating more often, feeling thirsty; losing your appetite, feeling or being sick (nausea or vomiting). Patients using an affected pen may want to check their blood sugar level more frequently until receiving a new cartridge holder. Patients should contact their healthcare provider if they believe they are experiencing hyperglycemia.
The recalled products were distributed between August 1, 2016, and June 22, 2017 to distributors, sales representatives, and replacement programs for further distribution to pharmacies, healthcare providers and patients nationwide. Recalled products display batch numbers EVG1221, EVG1226, FVG7149, FVG7458, FVG8134, or FVG8135.
See the FDA Safety Alert
See the Recall
See also Medical Law Perspectives Report: Diabetes and Its Complications: Malpractice and Other Liability Issues
See also Medical Law Perspectives Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication