The Partnership for Safe Medicines
SafeMeds Alert
MHRA Medical Device Alert
March 27, 2009
MHRA Warns Diabetics About Counterfeit Insulin Pen Needles 
 
Counterfeit batch of insulin pen needles found circulating in UK supply system
 
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."
 
MEDICAL DEVICE ALERT

MDA/2009/021 - Insulin pen needles: Labelled as Novo Nordisk Ltd Novofine� Needles 31G

Device
Insulin pen needles:
  • Labelled as Novo Nordisk Ltd Novofine� Needles 31G, 0.25 mm x 6 mm
  • Lot number 08J02S. The lot number can be found on the protective tab for the needle and on the carton label.
Problem
Counterfeit Novofine needles have been placed on the UK market. There is no assurance that counterfeit needles have been manufactured to the appropriate standards. Possible consequences of the use of counterfeit needles could include adverse reactions to the materials used; pain and discomfort; difficulty in attaching the needle to the pen injection device and infection.
 
Action
Pharmacists supplying these devices:
  • Do not supply needles with the lot number 08J02S.
  • Quarantine affected needles from your current stock and contact Novo Nordisk for replacements.
  • If a patient returns any Novofine needles with lot number 08J02S, supply the patient with a replacement and contact Novo Nordisk for replacement stock.
Healthcare professionals managing patients who use these devices:
  • Do not supply needles with the lot number 08J02S.
  • Advise patients to return needles from lot number 08J02S to either their pharmacist or to Novo Nordisk.
Contact
Manufacturer
David Wilkinson
Head of Safety & Complaints, UK-Ireland
Novo Nordisk Ltd
Tel: 01293 762 010
E-mail: dawi@novonordisk.com

Contact

Media Inquires
MHRA Press Office:
+44 (0)20 7084 3535 
 
Consumer Inquiries
Adverse Incident Centre Hotline: +44 (0)20 7084 3080
 
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About the SafeMeds Alert System
 
As part of the FDA's Alert Network, the SafeMeds Alert System is a free service that sends official alerts from the FDA and other government agencies around the world to anyone-private citizens, public groups, corporations, associations-when specific counterfeit drug incidents occur.
 

The SafeMeds Alert System is a service of the Partnership for Safe Medicines-a group of organizations and individuals that have policies, procedures, or programs to protect consumers from counterfeit or contraband medicines.  For more information, please visit SafeMedicines.org.