Warning over faulty NovoMix insulin pens and cartridges

Mon, 28 Oct 2013
People with diabetes in the UK who use Novo Nordisk's NovoMix 30 FlexPen/Penfill products are being advised to check their products following a warning from the Medicines and Healthcare products Regulatory Agency (MHRA).

According to the medicines watchdog, some batches of the NovoMix 30 Flexpen 100U/ml pre-filled pen and the Novomix 30 Penfill 100U/ml cartridge are being recalled due to a manufacturing problem during the filling of the cartridges, which resulted in some batches containing too high or too low amounts of insulin units per millilitre.

While only a small proportion of cartridges contain a wrong amount, the level of insulin in the affected cartridges may vary between 50% and 150% of the labelled insulin units, which could lead to hypoglycemia.

Patients with the NovoMix 30 FlexPen /Penfill are being urged to check for the following affected batch numbers, which are printed on the pen or cartridge:

NovoMix 30 FlexPen - 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.

NovoMix 30 Penfill - CS6D422, CS6C628, CS6C411.

Anyone who finds they have an insulin pen or cartridge from the affected batches should consult their GP or nurse as soon as possible to arrange for a new supply from unaffected batches or, if such batches are not available, to switch to alternative treatment.

In the meantime, both the MHRA and the European Medicines Agency (EMA), which issued the recall, stress that it is important that patients continue their treatment until contact with a healthcare professional has taken place.

The NovoMix 30 FlexPen/Penfill products are used to administer the diabetes medication NovoMix, which contains the active substance insulin aspart, in patients with insulin-dependent diabetes aged 10 years or over.
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