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).
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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.