Class 2 medicines recall: GlucaGen HypoKit 1mg (glucagon) PL 04668/0027 (GlucaGen 1mg) PL 04668/0028 (Solvent for GlucaGen 1mg)

Action within 48 hours: Novo Nordisk Ltd. is recalling seven batches of GlucaGen HypoKit due to a small number of needles being detached from the syringe.

Product information

EL number

EL (16)A/12

MDR number

MDR 010-09/16

Company name

NovoNordisk Ltd.

Product description

Batch Number Expiry Date First distributed
FS6W939 31/05/2018 26/02/2016
FS6X059 31/05/2018 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 06/05/2016

Brief description of the problem

Novo Nordisk Ltd. is recalling seven batches of GlucaGen HypoKit due to a small number of needles being detached from the syringe. It would not be possible to use a syringe with a detached needle which could cause a delay in emergency treatment of severe hypoglycaemia.

See Figure 1 below for the location of the batch number on the GlucaGen HypoKit.

Patients are asked to return their GlucaGen HypoKit to their community pharmacy for a replacement pack.

For stock and Medical Information enquiries contact Novo Nordisk customer service at 0845 600 5055 (24 hour contact number).

Download document

Class 2 medicines recall: GlucaGen HypoKit 1mg (glucagon) PL 04668/0027 (GlucaGen 1mg) PL 04668/0028 (Solvent for GlucaGen 1mg)

Figure 1. A) GlucaGen HypoKit where the batch number is found in the red box, B) close up of the batch number.

Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter. Local area teams are asked to forward this to relevant clinics, general practitioners and community pharmacists for information.

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