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NovoPen Echo insulin cartridges recalled in Australia

Important safety information for diabetes patients in possession of a NovoPen® Echo®

 

NovoPen®Echo®

 

Novo Nordisk A/S has detected that the insulin cartridge holder used in a small number of NovoPen® Echo® batches may crack or break if exposed to certain chemicals, for example certain cleaning agents. The reason for the cracking is that the plastic materials used for the cartridge holders in the affected batches can be weakened if exposed to certain chemicals found, for example, in some cleaning products.

 

Using a device with a cracked/broken cartridge holder can result in the device delivering a smaller dose of insulin than expected leading to high blood sugar levels. The risk of experiencing high blood sugar levels with the use of a device with an affected cartridge holder is evaluated to be less than 0.1 %, i.e. only 1 in 1000 patients will experience high blood sugar levels due to an affected cartridge holder.

 

When cleaning the pen as described in the User Guide, there is NO reason to believe that cracking of the cartridge holder will occur. All other batches include cartridge holders of a type where the issue with cracked and broken cartridge holders was not seen.

 

Novo Nordisk urges people with diabetes using a NovoPen® Echo® 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. 

 

The list of affected batches is shown in table below:

 

Batch no. as shown on NovoPen® Echo® carton

Batch no. as shown on NovoPen® Echo® pen

EVG3310-6

EVG3310

EVG4252-2

EVG4252

EVG4253-2

EVG4253

FVG8218-4

FVG8218

FVG8412-3

FVG8412

FVG8415-1

FVG8415

 

 

  • It is important to clean pens only as described in the User Guide
  • 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 levels 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 www.novonordisk.com.au or at www.novonordisk.com/novopenecho5.html in order to receive a replacement cartridge holder for your NovoPen® Echo® (after 7 working days, approximately).
  • Report any adverse events or complaints to the NovoCare® Customer Care Centre, which can be reached at 1800 668 626 or via email at aunrccc@novonordisk.com.

 

 

The advice to healthcare professionals is Novo Nordisk is recalling all pens in the affected batches not currently issued to a patient.  Where affected pens have been issued to a patient, Novo Nordisk urges patients to replace the cartridge holder, as some could be damaged. 

 

Please note if in use, the NovoPen® Echo® pen itself does not need to be replaced.

 

If you have any questions or concerns, you can contact the NovoCare® Customer Care Centre.

 

NovoCare® Customer Care Centre

Phone: 1800 668 626

Email: aunrccc@novonordisk.com

 

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