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New Zealand: Recall Of Novo Nordisk's Glucagen Hypokit

Discussion in 'Product Recalls' started by Ellen, Oct 22, 2010.

  1. Ellen

    Ellen Senior Member

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    http://www.voxy.co.nz/health/recall-novo-nordisk039s-glucagen-hypokit/5/68606

    Recall Of Novo Nordisk's Glucagen Hypokit
    Home ? Health
    Contributor:
    Voxy News Engine
    Thursday, 21 October, 2010 - 19:15

    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.
     
  2. kiwiliz

    kiwiliz Approved members

    Joined:
    Sep 25, 2008
    Messages:
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    Recall Notices

    Recall of one batch of GlucaGen? Hypokit 1mg injection to patient / consumer level

    The product is:GlucaGen? HypoKit 1mgBatch / Lot No:YW60362Expiry Date:11/2011
    Medsafe advises that the company, Novo Nordisk, is recalling one batch of this product because a small number of syringes may have cracks which could cause the diluent to leak out or become contaminated. Although the number of faulty units is low, it is important for these to be returned and replaced because if the diluent has leaked the product would not be usable in an emergency. There is also a small possibility that the product may have become contaminated.
    Pharmacists and doctors have been asked to contact patients / consumers they have supplied with the affected kits and ask them to return the kits for a free replacement.
    It is most important to know that this recall only applies to one batch and this batch has only been available since 22 July this year. The batch number is located on the right hand side of the main carton label (and also stated on the labels of the powder vial and sterile water syringe) - see the picture below.
    [​IMG]
    If the batch number is 'YW60362' only (no other batch numbers are affected), please return this product to your source of supply (probably your pharmacy or your doctor) as soon as possible for a free replacement.
    While affected kits should be returned as soon as possible, in the meantime, the syringe can be checked for signs of leakage or contamination (cloudiness) and, if satisfactory may be used in an emergency until a replacement is obtained.
    Further information about this recall can be obtained from Novo Nordisk
    Tel: 0800 733 737

    (Batch Number YW60459 was recalled in May 2010.)
    http://www.medsafe.govt.nz/hot/Recalls/GlucaGenAug2010.asp
    http://www.medsafe.govt.nz/hot/Recalls/GlucaGenOct2010.asp
     
    Last edited: Oct 22, 2010

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