The European Medicines Agency announced on Friday that various batches of Novo Nordisk's insulin products NovoMix 30 FlexPen and Penfill needed to be recalled after they were found to contain the wrong amount of insulin.
The EU attributed the recall to a manufacturing problem during the filling of the cartridges, some contained too many or too few insulin units per milliliter.
Patients or care providers may themselves 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.
Patients who have NovoMix 30 FlexPen/Penfill products from the affected batches should make an appointment with their doctor or nurse for switching treatment "as soon as it is feasible," the agency adds.
However, it stresses: "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. Patients who experience symptoms of hypo- or hyperglycaemia should contact a healthcare professional."
