Six batches have been recalled due to a risk the holders may crack or break, leading to dosing issues

Novo Nordisk, in consultation with the TGA, is recalling six batches of NovoPen Echo insulin cartridge holders after detecting a risk of cracking or breaking if exposed to certain cleaning chemicals.

Using a NovoPen Echo insulin cartridge holder that is cracked or broken could result in the device delivering a smaller dose of insulin than expected, which can lead to serious health consequences including hyperglycaemia.

The TGA says to note that there are no reported problems with the insulin being administered by these devices.

“Cracking and breaking should not occur if the device is cleaned in accordance with the instructions in the User Guide,” it says.

Novo Nordisk advises that the risk of patients experiencing high blood sugar levels due to an affected cartridge holder is extremely low.

However those with NovoPen Echo insulin cartridge holders from an affected batch are invited to contact Novo Nordisk to arrange to receive a replacement device.

If you have any unused stock of NovoPen Echo insulin cartridge holders, check the batch numbers to see if they are affected by this recall. Quarantine any devices from the affected batches.

The affected batch numbers are:

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

 

The TGA has asked pharmacists to contact any patients to whom they have supplied NovoPen Echo insulin cartridge holders since July 2014 and advise them of this issue.

NovoNordisk has provided a Patient Information Letter, which can be used to help communicate important information to patients. To request this letter, contact NovoNordisk on 1800 668 626.