Update: Additional Lot Recalled of the GlucaGen Hypokit for Diabetics

Starting date:

October 28, 2010

Posting date:

October 28, 2010

Type of communication:

Information Update

Subcategory:

Drugs

Source of recall:

Health Canada

Issue:

Product Safety

Audience:

General Public

Identification number:

RA-110003878

• 
  Reason
• 
  What you should do
• 
  Background
• 
  Affected products
• 
  Report health or safety concerns
• 
  Media enquiries
• 
  Public enquiries

Health Canada is informing Canadians that Novo Nordisk Canada Inc. is voluntarily recalling one lot (YW60462) of the GlucaGen Hypokit after a quality issue was identified that may affect a small number of kits in the affected lot.

Novo Nordisk Canada Inc. is requesting that wholesalers, pharmacies and hospitals immediately stop sale and recall the affected lot.

Reason

In the affected lot, some of the glass vials, which contain the active ingredient glucagon, have been found to be cracked or broken. Use of a cracked vial may result in glucagon fluid leakage and may make the product unusable, which could result in treatment delays if no back-up kit is readily available, and potential health risks.

What you should do

Affected kits should be returned to a pharmacy for replacement.

Canadians with questions or concerns about these products should speak to a physician or pharmacist, or contact Novo Nordisk Canada Inc. at 1-800-465-4334. Canadians are also reminded of the importance of visually inspecting their GlucaGen Hypokits before use.

Background

This recall is in addition to the two lots recalled in August due to a separate manufacturing concern (August 25, 2010, Health Canada communication).

Health Canada has not received any reports of incidents involving this issue.

Affected products

Report health or safety concerns

To report a suspected adverse reaction to these or other health products, please contact Health Canada's Canada Vigilance Program toll-free at 1-866-234-2345, or complete a Canada Vigilance Reporting Form and send it 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

Media enquiries

Health Canada

613-957-2983

Public enquiries

613-957-2991

1-866-225-0709