UPDATE TO PRESS RELEASE

Counterfeit NovoFine^® needles discovered in England

Important information to insulin users and healthcare professionals in the UK

Novo Nordisk and the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK are warning the public and healthcare professionals about the discovery of a small number of counterfeit NovoFine^® needles on the UK market.

The needles are not made by Novo Nordisk, the manufacturer of NovoFine^® needles and do not comply with the company’s stringent product quality standards. At this point, there is no information indicating that counterfeit needles have been sold in markets outside the UK.

The counterfeit needles are sized Fine 31g x 6mm and have the batch number 08J02S, expiry 08/2013.

The needles are used with Novo Nordisk’s insulin injection pens both the disposable and durable pen types.

Novo Nordisk has carried out a Health Hazard Evaluation which assessed that using the counterfeit product would most likely only cause minor adverse events such as local skin reactions around the injection site.

Novo Nordisk was alerted to the existence of counterfeit products following two customer complaints in England in March. The company immediately informed the local regulatory authorities in the UK, launched an investigation and increased monitoring of complaints.

Viggo L Birch, general manager, Novo Nordisk Ltd. says: “We have never before experienced counterfeit NovoFine^® needles. Novo Nordisk has product safety to patients as its top priority and is committed to fighting counterfeit products. We are doing our utmost to support the investigation carried out by the MHRA.”

How to detect a counterfeit NovoFine® needle:
The counterfeit product:

• Has a batch number of 08J02S
• Needle may not fit well on the device, as the thread is of inferior quality (this may cause leakage of insulin)
• The counterfeit packaging can be identified by the differences shown in the pictures below
• Outer box: Lacks a line underneath the CE number on each box containing a hundred individual needles:

Counterfeit box           

Genuine Novo Nordisk box

Sealing paper: Colour and font variations in print and on sealing paper. Differences in font of the batch number and expiry date, size of sealing paper, punching and the paper type. Coating on the back of sealing paper is visibly different, as well as adherence of sealing paper snip.

Product counterfeit of NovoFine^® 31G x 6mm     Original NovoFine^® 31 G x 6mm

Hub: Product counterfeit of NovoFine^® 31G x 6mm: Material differs in colour, exterior and interior surfaces are less smooth and there are traces of the milling process of the mold. Minor design differences, the thread in the hub is defective, lack of inner tower in hub, design of external guidance ridges, see photo for adhesive. Difference in exterior and interior diameter and wall thickness.

Product counterfeit of NovoFine^® 31G x 6mm 

Original NovoFine^® 31 G x 6mm

Adhesive: Product counterfeit of NovoFine^® 31G x 6mm: The cannula is glued to the hub with a transparent UV-adhesive. The original NovoFine^® is glued with a white adhesive, which is thermal cured.

Product counterfeit of NovoFine^® 31G x 6mm 

Original NovoFine^® 31 G x 6mm

Novo Nordisk is committed to ensuring high quality standards of product and safety are upheld and therefore we are in a close dialogue with the UK health authorities in order to secure patient safety and assist in the counterfeit criminal investigation.

What should insulin users do if they have purchased counterfeit needles?
If in doubt as to whether a product is counterfeit Novo Nordisk and the MHRA recommend that patients contact their pharmacy or Novo Nordisk UK customer complaints tel: 0845 6005055 for further information.

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