Press release: Urgent warning for diabetics about counterfeit insulin pen needles

Press release

Date:	27 Mar 2009
Time:	13:00
Subject:	Counterfeit diabetic needles
Contact:	Press Office 020 3080 7651 or press.office@mhra.gsi.gov.uk Out-of-hours 07770 446 189

The Medicines and Healthcare products Regulatory Agency (MHRA) is today warning diabetics about a counterfeit batch of insulin pen needles that are circulating in the UK.

The counterfeit needle details are: Novofine Needles 31G (0.25mm x 6mm) lot number 08J02S labelled as manufactured by Novo Nordisk Ltd. People who have these insulin pen needles should stop using them. They can return any affected needles to their pharmacist where they should also be able to obtain replacements.

There is no assurance that these counterfeit needles are manufactured to the appropriate quality standards. The possible consequences of using these counterfeit needles could include adverse reactions; pain and discomfort; infection and difficulty in attaching the needle to the pen injection device.

MHRA Director of Device Technology and Safety, Clive Bray said, “Please check the Novofine needles that you are using. If you are unsure about the needles you have, then please visit your pharmacist as they can assist you. Alternatively contact Novo Nordisk Ltd.

“The MHRA has issued a Medical Device Alert (MDA) today to healthcare professionals including pharmacists and specialist diabetic health workers. They have been asked to quarantine any affected stock and to stop supplying the affected needles.

"We encourage people to report faulty medical devices to the MHRA using the online form on our website: www.mhra.gov.uk. Reporting enquiries should be directed to the Adverse Incident Centre Hotline: 020 7084 3080, or by e-mail aic@mhra.gsi.gov.uk, or fax 020 7084 3109"

Notes to Editor

1. People can contact the manufacturer regarding their needles. Details are below. Novo Nordisk UK customer complaints on: 0845 6005055 for further information. Media enquiries: Viggo Birch on 07921 894899 or vlb@novonordisk.com
2. The insulin used with the pen injection device is not affected.
3. The MHRA is the government agency responsible for ensuring that medicines and medical devices work, and are acceptably safe. No product is risk-free. Underpinning all our work lie robust and fact-based judgements to ensure that the benefits to patients and the public justify the risks. We keep watch over medicines and devices, and take any necessary action to protect the public promptly if there is a problem. We encourage everyone – the public and healthcare professionals as well as the industry – to tell us about any problems with a medicine or medical device, so that we can investigate and take any necessary action. www.mhra.gov.uk