A small number of batches of the insulin medication NovoMix 30 FlexPen and Penfill (Novo Nordisk) are to be recalled in the EU. The European Medicines Agency (EMA) is recommending that diabetes patients using medicines from the affected batches should switch to products from unaffected batches or alternative treatments.
The affected batches are being recalled because of a manufacturing problem during the filling of the cartridges. The company says that only a small percentage of cartridges (0.14%) contain a wrong amount of insulin. However, in those affected, the level of insulin may vary between 50% and 150% of the labelled insulin units, which could lead to hypoglycemia or hyperglycemia.
Patients can check the batch number printed on the NovoMix 30 FlexPen or the NovoMix 30 Penfill to see whether their medicine is affected.
The numbers of the affected NovoMix 30 FlexPen batches are as follows: CP50912, CP50750, CP50639, CP51706, CP50940, CP50928, CP50903, CP50914, CP50640, CP51095, CP50904, CP50650, CP51098, CP50915, CP50412, CFG0003, CFG0002, CFG0001, CP50902, CP50749, CP50393, CP50950, CP51025, CP50751, CP50375, CP50420, CP51097, CP50641, CP51096 and CP50392.
The numbers of the affected NovoMix 30 Penfill batches are as follows: CS6D422, CS6C628 and CS6C411.
The EMA said: "If the batch number on their pen or cartridge does not correspond to any of the batch numbers listed below, there is no concern.”
For those who have products from the affected batches, the EMA said: “Patients should make an appointment with their doctor or nurse for switching treatment as soon as it is feasible.”
“It is important that these patients do not stop their treatment. Until contact with a healthcare professional has taken place, patients are advised to continue their treatment and to measure their blood glucose levels frequently to ensure adequate blood sugar control.”
Further information about the recall can be found on the EMA website.