Batches of the insulin medicine NovoMix 30 FlexPen and Penfill to be recalled

Patients using medicine from the affected batches should be switched to products from unaffected batches or alternative treatment

The European Medicines Agency is giving recommendations on how to deal with a recall of some batches of the diabetes medicine NovoMix 30 FlexPen and Penfill. The affected batches are being recalled 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 the marketing authorisation holder, 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 European Medicines Agency 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.

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