LONDON (Reuters) – The European Medicines Agency said on Friday that some batches of Novo Nordisk’s insulin products NovoMix 30 FlexPen and Penfill were being recalled because they might contain the wrong amount of insulin.
Due to a manufacturing problem during the filling of the cartridges, some contained too many or too few insulin units per millilitre, it said.
Only a very small proportion of cartridges – 0.14 percent – contain a wrong amount but in those affected the level of insulin may vary between 50 percent and 150 percent of the labelled dose.
The EU regulator said patients using products from the affected batches should be switched to supplies from unaffected batches or alternative treatments.
(Reporting by Ben Hirschler; editing by Clara Marques)
- European Medicines Agency
- Novo Nordisk