China plant dosage error leads to insulin recall for Novo Nordisk

By Dan Stanton

- Last updated on GMT

Related tags: Novo nordisk, European union, Insulin

Novo Nordisk recalls prefilled insulin batches
Novo Nordisk recalls prefilled insulin batches
Novo Nordisk has recalled 30 batches of a prefilled insulin product following a dosage error at a manufacturing facility in China.

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

“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.”

Related news

Show more

Related products

show more

A Better Approach, for Better Pain Trials

A Better Approach, for Better Pain Trials

Signant Health | 27-Sep-2021 | Technical / White Paper

Pain studies face unique challenges. For one, pain severity can only be truly assessed by the patients themselves. The controlled substances that are often...

Transforming Clinical Development

Transforming Clinical Development

PerkinElmer | 01-Jun-2021 | Technical / White Paper

The estimated cost of bringing a drug to market in the U.S. according to JAMA is $1 billion.1 The extreme cost of clinical trials urge biopharmaceutical,...

Vaccine Innovation in the Era of COVID19

Vaccine Innovation in the Era of COVID19

Covance Patient Safety | 01-Oct-2020 | Sponsored Link

During this time of worldwide crisis, there is an increasing demand for the acceleration of a vaccination for COVID19. Regardless of the great recent advancements...

Related suppliers

Follow us


View more