Danish pharmaceutical giant Novo Nordisk has recalled batches of faulty insulin pens in the UK, the MHRA has announced. Certain batches of the NovoPen Echo and NovoPen 5 are being recalled by the manufacturer as a precaution due to risk of malfunction.
In certain batches of the pens, there is a risk of the insulin cartridge holder cracking or breaking resulting in under delivery of insulin to the patient and leading to hyperglycaemia and further potentially life threatening complications. The risk of hyperglycaemia can affect 0.1% of patients.
This recall comes after a similar incident in Australia and the USA last month, when a batch of NovoPen Echo were identified as having the same problem.
This structural compromise to the cartridge occurs when the devices are exposed to certain household cleaning products.
The MHRA’s Director of Medical Devices, John Wilkinson has praised the prompt response of the pharmaceutical giant “This is a company-led recall and we are supportive of the proactive approach being taken by Novo Nordisk. It is important patients do not stop taking treatment without contacting their diabetes management team. We are asking people using NovoPen Echo and/or NovoPen 5 from one of the affected batches to contact Novo Nordisk to replace the cartridge holder as some could be damaged or subject to damage in the future. We continue to encourage people to report any issue involving medical devices to the MHRA via our Yellow Card Scheme”.
Patients with affected batch numbers are advised to consult their doctor or diabetes management team before stopping using the devices and to monitor any symptoms of hyperglycaemia such as increased urination, tiredness and thirst.
Patients using the NovoPen Echo and NovoPen 5 devices who are not sure if their devices are affected are urged to check the company led recall, and if they are, to contact the Novo Nordisk for a replacement cartridge holder on their customer care line: 0845 600 5055. Lines are open Monday-Friday 8am – 8pm and Saturday-Sunday 8am-4pm.
The batch numbers are available on the company website as well as images on how to locate the batch number.
Novo Nordisk have reassured the public there is no risk if the NovoPen Echo and NovoPen 5 are from a batch number not affected by this recall.
In his statement, Novo Nordisk’s Director of Clinical, Medical and Regulatory for UK and Ireland, Dr Avideh Nazeri said “Novo Nordisk is committed to delivering high quality products and sincerely apologises for this unfortunate situation and the concerns and inconveniences it may cause patients and healthcare professionals. We are working closely with the MHRA (Medicines and Healthcare products Regulatory Agency) and UK patient groups to ensure patient safety and minimise the disruption this situation causes”.