EMA recalls batches of the insulin medicine NovoMix 30 FlexPen and Penfill

Published: 29-Oct-2013

Owing to a manufacturing problem during the filling of the cartridges


The European Medicines Agency has recalled some batches of the diabetes medicine NovoMix 30 FlexPen and Penfill owing to 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 the marketing authorisation holder, Danish insulin specialist NovoNordisk, only a small percentage of cartridges (0.14%) contain the wrong amount of insulin. 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 are switched to products from unaffected batches or, if such batches are not available, to an alternative treatment.

The European Medicines Agency says it is monitoring the situation closely and will ensure that appropriate measures are being taken by the company, including immediate corrective actions as well as permanent technical solutions to prevent reoccurrence. All remaining units of the affected batches in Novo Nordisk control have been quarantined.

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.

The 12 batches affected by the quality defect have been distributed in the following EU states: Austria, Belgium, Czech Republic, Denmark, France, Germany, Iceland, Ireland, Luxembourg, Netherlands, Norway, Slovakia and the UK. However, other countries in the EU might have received the affected batches through parallel distribution.

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