Pharmaceutical company Novo Nordisk A/S, in consultation with the TGA, has initiated a consumer level recall of some batches of their NovoPen Echo insulin cartridge holder after detecting there is a possibility they may crack or break if exposed to chemicals in certain cleaning agents.
People using a device with a cracked or broken cartridge holder can result in the device delivering a smaller dose of insulin than expected leading to high blood sugar levels, potentially putting the person at risk of hyperglycaemia.
Novo Nordisk has advised that if people clean the pens as described in the User Guide, there is no reason that cracking of the cartridge holder will occur.
The recall only relates to some batches of the cartridge holders and there are no reported problems with the insulin being administered. Novo Nordisk advises that the risk of patients experiencing high blood sugar levels due to an affected cartridge holder is extremely low.
Novo Nordisk is recalling all pens in the affected batches not currently issued to a patient. People with diabetes who use a NovoPen Echo should immediately check the batch number and if it is from one of the affected batches they should not use it but apply to Nova Nordisk for a replacement.
Batch no. as shown on NovoPen® Echo® cartonBatch no. as shown on NovoPen® Echo® penEVG3310-6EVG3310EVG4252-2EVG4252EVG4253-2EVG4253FVG8218-4FVG8218FVG8412-3FVG8412FVG8415-1FVG8415
People using these pens should note the symptoms of hyperglycaemia, to measure their blood sugar levels as instructed by their health care provider and take appropriate action.
In the event anyone experiences symptoms of too high blood sugar levels involving this product should contact their doctor for advice.
If people do have a pen from the suspect batches they can register their 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 further information visit the TGA website.
Contact
