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Revised: 21 October 2010

Recall of Novo Nordisk's GlucaGen HypoKit

For the second time this year, medicine manufacturer Novo Nordisk is recalling a defective batch of GlucaGen HypoKit, which is used to treat severe hypoglycaemia (low blood sugar) in people using insulin or taking tablets to control their diabetes.

The company has reported that some of the glass vials containing the powder for injection in the affected batch had been cracked or broken during the manufacturing process.

Pharmacists and GPs are being asked by the product sponsor to check their own stocks of GlucaGen HypoKit and to contact patients and other organisations that they have supplied with units since 3 September 2010 when this batch was first distributed. Patients are being asked to return any kits they have bought since then to their pharmacy for replacement.

Up to 3000 kits may be affected that have been distributed to pharmacists and some of these distributed to patients.

Novo Nordisk has imported additional supplies of unaffected GlucaGen HypoKits to replace the defective stock. The new stock will be available for distribution from wholesalers from midday Friday.

The Ministry is aware of the inconvenience this may be causing before the long weekend. Individuals who rely on these kits who will be away from major centres during the weekend should check with their pharmacist or GP before they go about the steps they should take before they travel Consumers can also phone Healthline 0800 611 116 for information about this recall and advice.

Medsafe is working with the company to ensure appropriate information had been provided to community and hospital pharmacy and medical practitioners.

Medsafe is advising – the Pharmaceutical Society and the Pharmacy Guild about the recall so they are able to help assist pharmacists involved in the recall.

Novo Nordisk is managing the recall of this medicine and the Ministry will be watching the recall closely.

Once this recall is completed the Medsafe will be seeking assurances from both the New Zealand product sponsor and the Danish manufacturer that the problem causing both recalls has been appropriately addressed.

ENDS

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