Novo Nordisk has informed the World Federation of Hemophilia and the European Haemophilia Consortium that in January of this year, the company initiated a recall of 3 batches of the recombinant factor FVIII product – NovoEight – because of a potential risk that one of the 972 syringes in these batches could contain glass particles.
No adverse events and no customer complaints related to this issue have been reported. All packs from the affected batches have been recovered and treatment centres and patients have received replacement products. The recalled batches were distributed only in Germany and Spain and the recall was completed by February 7.
Novo Nordisk issued a statement that, “The risk of any packs from the affected batches remaining in the distribution chain or with patients has been successfully eliminated. Novo Nordisk has in cooperation with the supplier of the syringes taken corrective actions to ensure that a similar event does not happen again.”
Upon receiving this information, the EHC took the immediate action of informing its German and Spanish NMOs.