Sanofi recalls all lots of Allerject (0.15 mg/0.15 mL and 0.3 mg/0.3 mL strengths of epinephrine auto-injectors)

Starting date:
October 28, 2015
Posting date:
October 28, 2015
Type of communication:
Advisory
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Product Safety
Audience:
General Public
Identification number:
RA-55620

Issue

Sanofi-aventis Canada Inc., in consultation with Health Canada, is recalling all lots of Allerject (0.15 mg/0.15mL and 0.3 mg/0.3 mL strength epinephrine auto-injectors) from the Canadian market. A similar recall is taking place in the United States, where it’s sold as Auvi-Q.

This recall is due to issues that may potentially affect the delivery of the required amount of the drug, epinephrine. Allerject is used as an emergency treatment by patients who are at risk and/or have a history of serious allergic reactions (anaphylaxis).

In light of the need to manage supply associated with this recall, we are asking customers and pharmacists to limit the replacement of Allerject to one unit or the appropriate number of units as instructed by your healthcare professional until full alternative stock is available.

Products affected

  1. Allerject Pre-filled Autoinjector (DIN02382059 – 0.15mg/0.15mL epinephrine).
  2. Allerject Pre-filled Autoinjector (DIN02382067 – 0.3mg/0.3mL epinephrine).

What you should do

  • Contact your pharmacy to arrange returning your Allerject device and to obtain a replacement epinephrine auto-injector with the same dose.
  • Consult your pharmacist to ensure you understand how to properly use the replacement auto-injector.
  • In the event a life-threatening allergic reaction (anaphylaxis) occurs before you can obtain a replacement auto injector, use your Allerject device as directed by your healthcare provider, and then seek emergency medical attention.
  • Speak with your healthcare professional if you are concerned about your health or your child’s health.
  • Report any adverse events to Health Canada.

Who is affected

Adults and children who use Allerject (0.15 mg / 0.15 mL and 0.3 mg/0.3 mL auto-injector).

Report health or safety concerns

How to report side effects to health products to Health Canada:

  • Call toll-free at 1-866-234-2345
  • Visit MedEffect Canada's web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.

Stay connected with Health Canada and receive the latest advisories and product recalls using social media tools.

Media enquiries

Health Canada
(613) 957-2983

Public enquiries

(613) 957-2991
1-866 225-0709

What Health Canada is doing

Health Canada is monitoring the company’s recall and will inform Canadians if any new information arises.

Images

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For more information

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.

More information is also available from sanofi-aventis Canada Inc. by calling the Allerject call centre at 1-855-405-4321 or on the sanofi-aventis Canada Inc. website (www.sanofi.ca).