NovoMix
Due to a manufacturing problem during the filling of the cartridges, individual products of the above mentioned batches of "NovoMix® 30 FLexPen®" may have an insulin content that is too high or too low. According to information from the Danish marketing authorization holder, NovoNordisk A/S, the insulin concentration may deviate in a small number of the products (0.14%). However, the insulin content of these affected cartridges may vary between 50% and 150% of the declared insulin amount, which could lead to hypoglycemia or hyperglycemia in patients. As it is not possible to identify the out-of-specification products, Novo Nordisk Pharma GmbH is replacing the affected batches as a precautionary measure. Affected batches are in circulation throughout Europe and the market withdrawal is being monitored by the European Medicines Agency (EMA) and the national medicines authorities concerned.
| Name of the medicinal product | NovoMix® 30 FlexPen® 100 E/ml Injektionssuspension in einem Fertigpen |
|---|---|
| Marketing authorisation number(s) | EU/1/00/142/009 |
| Batch number(s) | CP50912, CP50639, CP50750 |
| Classification of the recall | 1 |
| BASG reference number | INS-640.001-0926 |
| Safety warnings Link | BASG-Sicherheitsinformation |
| Further information Link | Chargenaustausch |
