Press release

Recall of GlucaGen® HypoKits used by diabetics in an emergency

People with diabetes are being asked to check whether they have certain batches of GlucaGen® HypoKits used for the emergency treatment of severe low blood glucose (hypoglycaemia).

The Medicines and Healthcare products Regulatory Agency has issued a patient level drug recall of the affected batches.

An investigation by the manufacturer, Novo Nordisk, found a small percentage (0.006%) of needles have detached from the syringe in the GlucaGen® HypoKit which makes them unusable.

A delay in treatment could have severe health consequences in an emergency situation and, therefore, any affected batches should not be used.

Those with a GlucaGen HypoKit from an affected batch are asked to return them to their pharmacist for a replacement.

Batch Expiry First Distributed
FS6W939 31/5/2018 26/02/2016
FS6X059 31/5/2018 03/03/2016
FS6X196 30/09/2018 11/03/2016
FS6X590 31/08/2018 29/03/2016
FS6X717 31/08/2018 22/03/2016
FS6X899 31/08/2018 18/04/2016
FS6Y024 30/09/2018 06/06/2016

Gerald Heddell, MHRA’s Director of Inspection, Enforcement and Standards said:

Whilst only a small number of these kits are affected by this fault it is important that people are confident their treatment will be effective in the event of emergency.

People with these kits should check which batch their kit is from and, where necessary, get a replacement from a pharmacist.

We continue to encourage people to report any issues to the MHRA via our Yellow Card Scheme.

Libby Dowling Senior Clinical Advisor at Diabetes UK said:

These can provide vital lifesaving treatment in emergency situations. It is important that people check the batch numbers and take appropriate action.

If you have any questions about your blood glucose levels you should contact your diabetes care team.

Ends

Notes to Editor

  1. Please see the link to the Drug Alert
  2. Please find the link to the Yellow Card Scheme.
  3. Where to find the batch number (JPEG, 27.7KB)

  4. MHRA is responsible for regulating all medicines and medical devices in the UK. All our work is underpinned by robust and fact-based judgments to ensure that the benefits justify any risks. MHRA is a centre of the Medicines and Healthcare products Regulatory Agency which also includes the National Institute for Biological Standards and Control (NIBSC) and the Clinical Practice Research Datalink (CPRD). The Agency is an executive agency of the Department of Health. www.mhra.gov.uk

Media enquiries

News centre
MHRA
151 Buckingham Palace Road
Victoria

London
SW1W 9SZ

Office hours are Monday to Friday, 8:30am to 5pm. For real-time updates including the latest press releases and news statements, see our Twitter channel at https://www.twitter.com/mhrapress