Diabetes patients in Europe were warned to be on alert after Novo Nordisk announced a recall of several batches of its NovoMix insulin.
The recall affects batches of the prefilled insulin product NovoMix30 FlexPen in Austria, Belgium, Czech Republic, Denmark, France, Germany, Iceland, Luxemburg, Netherlands, Norway and Slovakia, while batches of NovoMix Penfill have been recalled in the UK and Ireland.
Novo explained that the recall was down to an incorrect amount of insulin found in some (0.14 per cent) of the products contained in these batches.
The financial impact of the recall for Novo is unclear, although the NovoMix managed revenues of 2.5bn Danish krone (about €335m) in Europe during 2012.
The Danish pharma company warned use of the affected products “may lead to the patient’s blood sugar level becoming higher or lower than expected”.
It added: “To protect patient safety Novo Nordisk is recalling all products in the affected batches from wholesalers, pharmacies and patients.”
The level of insulin could be up 50 per cent less than expected or 150 per cent more, according to the European Medicines Agency (EMA).
The regulator advised that patients and careers check the batch number printed on the pens and contact their doctor to obtain a replacement if their product is from an affected batch.
Patients using a pen from one of the batches should not stop treatment while waiting to see their doctor, although they are advised to measure blood glucose levels frequently.
No explanation for the error was provided, although Novo said it “sincerely apologises for this unfortunate situation and the concerns and inconvenience it may cause patients and health care professionals”.
“We are working closely with national health authorities to ensure patient safety and minimise the disruption this recall causes,” added Novo.
The EMA said it was “monitoring the situation closely and will ensure that appropriate measures are being taken by the company, including immediate corrective actions as well as permanent technical solutions to prevent reoccurrence”.