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

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	Immediate action
	Immediate action update
	Action
	Action update

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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.

Distribution
This MDA has been distributed to:

• NHS trusts in England (Chief Executives)
• Commission for Social Care Inspection (CSCI) (Headquarters)
• Healthcare Commission (CHAI) (Headquarters)
• Health Protection Agency (HPA) (Directors)
• NHS Boards in Scotland (Chief Executives)
• Primary care trusts in England (Chief Executives)
• Social services in England (Directors)

Onward distribution
Please bring this notice to the attention of all who need to know or be aware of it. This may include distribution by:

Trusts to:
CAS liaison officers for onward distribution to all relevant staff including:

• A&E departments
• All wards
• Clinical governance leads
• Diabetes clinics/outpatients
• Diabetes nurse specialists
• Diabetes, directors of
• Diabetics departments
• Endocrinology units
• Endocrinology, directors of
• Health and safety managers
• Intensive care units
• Medical directors
• Nursing executive directors
• Occupational health departments
• Outpatient clinics
• Paediatric wards
• Pharmacists
• Risk managers
• Supplies managers

Commission for Social Care Inspection (CSCI) to:
Headquarters for onward distribution to:

• Care homes providing nursing care (adults)
• Care homes providing personal care (adults)
• Domiciliary care providers

Healthcare Commission (CHAI) to:
Headquarters for onward distribution to:

• Clinics
• Hospices
• Hospitals in the independent sector
• Independent treatment centres
• Private medical practitioners

Health Protection Agency to:
Directors for onward distribution to:

• Heads of department
• Heads of health, safety and quality
• Health protection nurses
• Risk manager
• Safety advisors

Primary care trusts to:
CAS liaison officers for onward distribution to all relevant staff including:

• Community children’s nurses
• Community diabetes specialist nurses
• Community hospitals
• Community midwives
• Community nurses
• Community pharmacists
• District nurses
• General practitioners
• Health visitors
• NHS walk-in centres
• Occupational health departments
• Pharmaceutical advisors
• Practice managers
• Practice nurses
• School nurses
• Walk-in centres

Social services to:
Liaison officers for onward distribution to all relevant staff including:

• Care at home staff
• Day centres (older people, learning disabilities, mental health, physical disabilities, respite care, autistic services)

Change of address or removal from address list for CSCI and Healthcare Commission:
CSCI Customer Service Unit
St Nicholas Building
St Nicholas Street
Newcastle-upon-Tyne
NE1 1NB
Tel: 0845 015 0120
E-mail: enquiries@csci.gsi.gov.uk

Healthcare Commission
Finsbury Tower
103-105 Bunhill Row
London
EC1Y 8TG
Tel: 020 7448 0842
E-mail: contacts@healthcarecommission.org.uk

Contacts
Manufacturer
David Wilkinson
Head of Safety & Complaints, UK-Ireland
Novo Nordisk Ltd
Broadfield Park
Brighton Road
Crawley
West Sussex
RH11 9RT

Tel: 01293 762 010
E-mail: dawi@novonordisk.com

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England
If you are in England, please send enquiries about this notice to the MHRA, quoting reference number MDA/2009/021 or 2009/003/026/051/001.

Technical aspects
Bina Mackenzie and Allan Hidderley
Medicines & Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London
SW8 5NQ
Tel: 020 7084 3229/3172
Fax: 020 7084 3106
E-mail: bina.mackenzie@mhra.gsi.gov.uk
allan.hidderley@mhra.gsi.gov.uk

Clinical aspects
Christopher Brittain
Medicines & Healthcare products Regulatory Agency
Market Towers
1 Nine Elms Lane
London
SW8 5NQ
Tel: 020 7084 3126
Fax: 020 7084 3111
E-mail: christopher.brittain@mhra.gsi.gov.uk

Northern Ireland
Enquiries in Northern Ireland should be addressed to:
Northern Ireland Adverse Incident Centre (NIAIC)
Health Estates
Estate Policy Directorate
Stoney Road
Dundonald
Belfast
BT16 1US
Tel: 02890 523 704
Fax: 02890 523 900
E-mail: NIAIC@dhsspsni.gov.uk
http://www.dhsspsni.gov.uk/index/hea/niaic.htm

Scotland
Enquiries and adverse incident reports in Scotland should be addressed to:

Incident Reporting and Investigation Centre
Health Facilities Scotland
NHS National Services Scotland
Gyle Square
1 South Gyle Crescent
Edinburgh
EH12 9EB
Tel: 0131 275 7575
Fax: 0131 314 0722
E-mail: iric@shs.csa.scot.nhs.uk
http://www.hfs.scot.nhs.uk/online-services/incident-reporting-and-investigation-centre-iric/

Wales
Enquiries in Wales should be addressed to:
National Assembly for Wales
HIMTE 3 Division
NHS Directorate
Cathays Park
Cardiff
CF10 3NQ
Tel: 029 2082 3373
Fax: 029 2082 5479
E-mail: Haz-Aic@wales.gsi.gov.uk

How to report adverse incidents
Please report via our website http://www.mhra.gov.uk
Further information about CAS can be found at https://www.cas.dh.gov.uk/Home.aspx