China plant dosage error leads to insulin recall for Novo Nordisk
The affected batches of the Danish drugmaker’s NovoMix 30 FlexPen and Penfill may have been subject to a manufacturing problem where prefilled cartridges were subject to either too low or too high a dose of insulin.
“The cause of the recall is a production error discovered at our manufacturing site in Tianjin, China,” Novo Nordisk spokesperson Katrine Rud von Sperling told in-Pharmatechnologist.com.
“The root cause has been identified and a new procedure is in place in order to ensure the error cannot happen again.”
The batches affected were distributed across a number of EU states - Austria, Belgium, Czech Republic, Denmark, France, Germany, Iceland, Ireland, Luxemburg, Netherlands, Norway, Slovakia and UK - and thus led to a recall alert by the European Medicines Agency (EMA).
Though the error only affected a small amount of the cartridges - 0.14% - there was some concern as the insulin level in these products varied between 50% and 150% of the labeled units and can therefore lead to either hypoglycaemia or hyperglycaemia.
This publication contacted Diabetes UK regarding what this might mean to the patient and Director of Health Intelligence, Simon O'Neill, said: “The important thing is that anyone affected by this must keep taking their insulin but should get it replaced at the earliest opportunity.
“We recommend people test their blood glucose levels regularly and be aware that their glucose levels may potentially run higher or lower.”
