- Company Announcement Date:
- FDA Publish Date:
- Product Type:
- Medical Devices
General Hospital & Personal Use
- Reason for Announcement:
Recall Reason DescriptionDevice may crack or break if exposed to certain chemicals
- Company Name:
- Novo Nordisk
- Brand Name:
Brand Name(s)NovoPen Echo
- Product Description:
Product DescriptionInsulin delivery device
Novo Nordisk is initiating 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, like certain cleaning agents. 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 health care provider if they believe they’re experiencing hyperglycemia.
The affected batches were distributed between 8/1/2016 – 6/22/2017 to distributors, sales representatives and replacement programs for further distribution to pharmacies, healthcare providers and patients nationwide.
Novo Nordisk is notifying distributors, pharmacies, healthcare professionals and patients by mail and is arranging for product replacement. Replacement cartridge holders will be provided for NovoPen Echo® from the following batches:
U.S. batch numbers
If patients are in possession of a NovoPen Echo® device with a batch number which is not mentioned above, there is no reason for concern and they can be confident that the pen will work as intended.
Novo Nordisk has received numerous complaints of damaged cartridge holders and has received some reports of adverse events to date.
Novo Nordisk has corrected this problem and has determined no other component of the pen is affected.
Novo Nordisk is committed to delivering high-quality products and sincerely apologizes to patients and health care professionals. We are working closely with the U.S Food and Drug Administration to ensure patient safety and further minimize disruption.
In the United States, people with diabetes using a NovoPen Echo® from one of the affected batches listed above are instructed to call Novo Nordisk at 1-855-419-8827 between 8 am and 6 pm EDT to get a replacement cartridge holder. For questions specific to the recall, please call 1-855-419-8827. If you have any other general questions or concerns, please contact Novo Nordisk Customer Care at 1-800-727-6500, Monday-Friday, 8:30 am – 6 pm EDT.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or
- call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
About Novo Nordisk
Novo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat other serious chronic conditions: hemophilia, growth disorders and obesity. With U.S. headquarters in Plainsboro, N.J., Novo Nordisk Inc. has nearly 5,000 employees in the United States. For more information, visit novonordisk.us or follow us on Twitter: @novonordiskus.
Company Contact Information
- Novo Nordisk Customer Care