Important Diabetes Information: GlucaGen Hypokit being Recalled in Canada

Notice to the reader: this document has been updated by an Information Update dated October 28, 2010.

Information Update
2010-145
August 25, 2010
For immediate release

OTTAWA – Health Canada is informing Canadians that Novo Nordisk Canada Inc. has agreed to voluntarily recall two lots (YW60335 and YW60351) of their product, GlucaGen Hypokit (DIN 02333627) currently available on the Canadian market.

GlucaGen is indicated for the treatment of severe hypoglycemic reactions which may occur in the management of insulin treated persons with diabetes mellitus, when unconsciousness precludes the use of oral carbohydrates.

This information comes as a result of a manufacturing defect identified in the pre-filled syringes. As of today, Health Canada has not received any adverse reactions from the use of these lots.

GlucaGen Hypokit is supplied with a vial of lyophilized GlucaGen and a pre-filled diluent syringe. The diluent syringe is used to reconstitute the lyophilized product and to administer the dose intramuscularly.

Novo Nordisk Canada Inc. is requesting that wholesalers, pharmacies and hospitals immediately stop sale and recall the affected lots. Health Canada reminds Canadians who have concerns about these products to consult with their health care practitioners or contact Novo Nordisk Canada Inc. at 1-800-465-4334.

Health Canada will continue monitoring the safety of all health products on the Canadian market, including those sold by Novo Nordisk Canada Inc. and will inform Canadians if new safety information arises.

Canadians can be confident that should any risks to health be identified, Health Canada will take immediate and appropriate action to help protect the health and safety of Canadians.

Consumers and health professionals wanting more information about this advisory from Health Canada can contact the Public Enquiries Line at 613-957-2991, or toll free at 1-866-225-0709.

Media enquiries related to this Advisory should be directed to Health Canada Media Relations at 613-957-2983.

To report suspected adverse reaction to these or other health products, please contact the Canada Vigilance Program of Health Canada toll-free at 1-866-234-2345, or complete a Canada Vigilance Reporting Form and send to us using one of these methods:

• Fax: 1-866-678-6789
• E-mail: CanadaVigilance@hc-sc.gc.ca
• Internet: www.healthcanada.gc.ca/medeffect
• Mail:
  Canada Vigilance Program
  Marketed Health Products Directorate
  Ottawa, ON, Address Locator 0701C
  K1A 0K9

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Media Inquiries:
Health Canada
(613) 957-2983

Public Inquiries:
(613) 957-2991
1-866 225-0709