Important safety information regarding NovoPen® Echo® and NovoPen® 5

Novo Nordisk A/S has detected that the insulin cartridge holder used in a small number of NovoPen® Echo® and NovoPen® 5 batches may crack or break if exposed to certain chemicals, for example certain cleaning agents. NovoPen® Echo® and NovoPen® 5 are used for insulin treatment by people with diabetes. 
 

Cartridge Holder Replacement

Novo Nordisk urges people with diabetes using a NovoPen® Echo® and/or NovoPen® 5 from one of the affected batches to replace the cartridge holder as some could be damaged. Please check your device batch number against the list of affected batches which can be found here:

NovoPen® Echo®  NovoPen® 5


The batch numbers are printed on NovoPen® Echo® and NovoPen® 5 as indicated below.

 

A

NovoPen® Echo®

B

NovoPen® 5

Red squares show where the batch number is located on A) NovoPen® Echo® and B) NovoPen® 5. E.g. the batch number on the NovoPen® Echo® to the left is FVG7364.


 
Check if your pen is from an affected batch. All affected batch numbers consist of three letters followed by four numbers only
 
 

In the United States, people with diabetes using a NovoPen Echo® from one of the affected batches 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.

If you are in possession of a NovoPen® Echo® and/or a NovoPen® 5 with a batch number which is not mentioned in the list, there is no cause for concern and you can trust that the device will work as intended.