Novo Nordisk A/S in Denmark is recalling a defective batch of GlucaGen® Hypokit, which is used to treat severe hypoglycaemia (low blood sugar) in diabetics. The batch is recalled because of the risk that some of the glass vials containing the powder for injection could be cracked or broken.
The batch affected is only batch/lot number: YW60417 which expires January 2013. This batch has been available on the Danish market since 18 August 2010. No other batch/lot numbers are being recalled.
Patients can receive a free replacement at pharmacies
If you have bought a GlucaGen® Hypokit with batch/lot number YW60417, please return it to your nearest pharmacy for a free replacement. The batch/lot number is horizontally located on the right hand side of the main carton label or on the labels of the powder vial and sterile syringe.
Why the affected GlucaGen® Hypokit batch is recalled
The Hypokit contains a sterile water syringe and a powder vial with lyophilised glucagon. The batch is recalled because of the risk that a small number of glass vials could have been cracked or broken during the manufacturing process. Although, only a small number of Hypokits are defective, it is important that they are returned and replaced with new Hypokits, as it will not be possible to use the product.
The press release issued by Novo Nordisk is available in the factbox to the right (in Danish only).
For further information, please contact Charlotte Henriksen on +45 4488 9251.
Danish Medicines Agency, 22 October 2010