The problem

Novo Nordisk A/S has recalled 4 batches of NovoPen® Echo®, used for insulin treatment by people with diabetes. The insulin cartridge holder used in some batches may crack or break if exposed to certain chemicals, for example certain cleaning agents. It is important to clean pens only as described in the User Guide.

Medsafe is monitoring the consumer level recall of NovoPen® Echo® and any adverse events that may be reported.

Details

Affected NovoPen® Echo® units have the batch numbers below:

  • EVG3310-6
  • EVG4252-2
  • FVG8412-3
  • FVG8415-1

What to do

People with diabetes using a NovoPen® Echo® pen from one of the affected batches should replace the cartridge holder (pictured right), as some could be damaged.

How to check if your device is affected

1. Batch numbers are printed on the NovoPen® Echo® (see below).

2. Remove the cartridge holder from your pen and turn the dial on the pen so that the batch number becomes visible. The red square shows where the batch number is located on the NovoPen® Echo®. (Note this is an example only and this batch has not been distributed in New Zealand).

3. Write down the batch number printed on your NovoPen® Echo® and check to see if it is in the list of affected batches.

If your NovoPen® Echo® has not yet been removed from the original carton it came in, check the batch number printed on the carton. The red square shows where the batch number is located on the NovoPen® Echo® carton.

What to do if you have a recalled NovoPen Echo®

  • Do not stop treatment without consulting your doctor.

  • Be aware of the symptoms of hyperglycaemia. If you note these symptoms, measure your blood sugar levels as instructed by your health care provider and take appropriate action.

  • In the event that you experience symptoms of too high blood sugar involving this product, contact your doctor for advice.

  • Register your contact details (name, address, phone number, email and number of affected cartridge holders) either at the local Novo Nordisk website or at Novo Nordisk’s corporate website in order to receive a replacement cartridge holder for your NovoPen® Echo®. You should attach and use this as stated in the NovoPen® Echo® User Guide, pages 2-4.

  • Report any adverse events or complaints to the NovoCare® Customer Care Centre, which can be reached at 0800 733 737 or via email at aunrccc@novonordisk.com.

What to do if the batch number on your NovoPen® Echo® is not one of the numbers listed above

If you have a NovoPen Echo® without one of the batch numbers mentioned above, or NovoPen® 3 or NovoPen® 4 products, there is NO concern and you can be confident that the products will work as intended. It is important to clean pens only as described in the NovoPen® Echo® User Guide.

How to report adverse events

Email: devices@moh.govt.nz
Online: http://www.medsafe.govt.nz/regulatory/devicesnew/9AdverseEvent.asp
Post: Compliance Management Branch, Medsafe, PO Box 5013, Wellington 6415.

For more information, contact the NovoCare® Customer Care Centre on 0800 733 737 or email aunrccc@novonordisk.com.

Information provided by Product Recalls — part of the Ministry of Business, Innovation and Employment.