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Health Canada Health products

Bausch Health, Canada Inc. recalls all lots of Emerade epinephrine auto-injectors (0.3 mg and 0.5 mg strengths) due to possible device failure

Issued May 5, 2023
Issue
Bausch Health, Canada Inc. is recalling all lots of Emerade epinephrine auto-injectors (0.3 mg and 0.5 mg) after testing by the company identified the potential risk that the auto-injector may fail to activate, or it may activate prematurely if dropped. The affected lots of Emerade were distributed in Canada between April 2022 and May 2023. Emerade auto-injectors are used to deliver an emergency treatment of epinephrine to patients who are at risk or have a history of serious allergic reactions (anaphylaxis). Failure of the auto-injector to activate may result in patients not receiving the required dose of epinephrine, leading to the worsening of symptoms of anaphylaxis which could be life-threatening. Health Canada recognizes how important epinephrine auto-injectors are for people with life-threatening allergies. There are alternative epinephrine auto-injectors available in Canada. Ensuring Canadians can get the medicines they need is one of Health Canada’s top priorities. A shortage of alternative products is not expected, but the Department will continue to actively monitor the supply situation.
Hazard description
Other
What to do
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 Emerade device and then seek emergency medical attention. Speak with your healthcare professional if you are concerned about your health. Contact Bausch Health, Canada Inc. by calling 1-800-361-4261, or emailing canada.customerservice@bauschhealth.com , if you have questions about the recall. Report any health product-related side effects or complaints to Health Canada.
Product
Product name
Emerade epinephrine auto-injectors, 0.3 mg (DIN 02458446) and 0.5 mg (DIN 02458454)
Reference
ID
RA-73621