A product recall has been issued for certain batches of NovoMix 30 FlexPen and Penfill insulin because of a manufacturing problem during the filling of the cartridges, which resulted in some batches of NovoMix 30 containing too high or too low amounts of insulin units per millilitre.
According to information from NovoNordisk A/S, it appears that only a small percentage of cartridges (0.14%) contain a wrong amount. However, in the affected cartridges the level of insulin may vary between 50% and 150% of the labelled insulin units, which could lead to hypoglycaemia or hyperglycaemia.
The EMA therefore recommends that patients using NovoMix 30 FlexPen/Penfill from the affected batches be switched to products from unaffected batches or, if such batches are not available, to alternative treatment.
Patients or carers may themselves check the batch number printed on the NovoMix 30 FlexPen or the NovoMix 30 Penfill to see if their medicine is affected. If the batch number on their pen or cartridge does not correspond to any of the batch numbers listed below there is no concern.
People 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. If your surgery is closed, you might want to discuss this with your pharmacist.
Do not stop treatment
It is important that people do not stop their treatment. Until contact with a healthcare professional has taken place, people are advised to continue their treatment and to measure their blood glucose levels frequently to ensure adequate blood sugar control. People who experience symptoms of hypo- or hyperglycaemia should contact a healthcare professional.
The numbers of the affected NovoMix 30 FlexPen batches are: 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: CS6D422, CS6C628 and CS6C411.
The batch numbers are printed on the pen for NovoMix 30 FlexPen and on the cartridge for NovoMix 30 Penfill.
Gerald Heddell, Director of Inspection, Enforcement and Standards at the Medicines and Healthcare products Regulatory Agency (MHRA), said, "Patients who use this product should check the batch numbers to see if their medicine is affected. If it is not listed as part of the recall, they should continue to take it as prescribed.
"Any patients with affected medicines should consult their GP or nurse to make arrangements for a new supply as soon possible.
"In the meantime, it is important that patients do not stop their treatment. They are advised to continue taking their medicine but to measure their blood glucose levels frequently to ensure adequate blood sugar control and that they are in close contact with their carer, a friend or family member who can get medical help if necessary. Patients who experience symptoms of hypo- or hyperglycaemia should contact a healthcare professional immediately."
Simon O'Neill, Diabetes UK's Director of Health Intelligence and Professional Liaison, said, "The important thing is that anyone affected by this must keep taking their insulin but should get it replaced at the earliest opportunity. We recommend people test their blood glucose levels regularly and be aware that their glucose levels may potentially run higher or lower."
More about the medicine
NovoMix is a diabetes medicine that contains the active substance insulin aspart. It is available in a range of suspensions for injection in cartridges (Penfill) and prefilled pens (FlexPen).
NovoMix 30 contains 30% soluble (rapid-acting) insulin aspart and 70% protamine-crystallised (intermediate-acting) insulin aspart. It can be used in patients aged 10 years or over.
The other strengths of NovoMix are not affected.