Advisory - Two Lots of Allerject (0.15 mg / 0.15mL auto-injector) For Use In Children Recalled Due to Manufacturing Defect

OTTAWA, June 13, 2015  /CNW/ -

The issue:

Sanofi-aventis Canada Inc., in consultation with Health Canada, is recalling two lots (2857508 and 2857505) of Allerject (0.15 mg / 0.15 mL auto-injector) due to a manufacturing defect that may prevent the device from working properly.

As a result of a manufacturing defect with the needle, the device may not deliver the epinephrine needed for emergency treatment of serious allergic reactions (anaphylaxis), which can pose serious health risks to patients. Anaphylaxis may cause death. The dosage strength for this pre-filled, single-use auto injector is intended for use in children weighing between 15 kilograms and 30 kilograms. The affected lots were distributed starting June 1, 2015.

Who is affected:

Children who use the Allerject (0.15 mg / 0.15 mL auto-injector) for emergency treatment of serious allergic reactions.

What consumers should do:

• The parents and caregivers of children using this product are advised to check the lot numbers of their Allerject (0.15 mg / 0.15 mL auto-injector) and return all affected product to their pharmacy for replacement auto-injectors with the same dosage of epinephrine.
• They should also speak with their pharmacists to ensure they properly understand how to use the replacement auto-injector if it is different from the one they have been using.
• Parents and caregivers of children using this product who have concerns about their child's health should speak to their healthcare professional.
• Report any adverse events to Health Canada.

What Health Canada is doing:

Health Canada will monitor the company's recall and will inform Canadians should new information arise.

Products recalled/affected:

Allerject (0.15 mg / 0.15 mL auto-injector), lots 2857508 and 2857505, DIN 02382059. The affected lots were distributed starting June 1, 2015.

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).

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.

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SOURCE Health Canada

PDF available at: http://stream1.newswire.ca/media/2015/06/13/20150613_C5763_PDF_EN_18052.pdf