Bausch Health Canada recalls all lots of its Emerade epinephrine auto-injectors in 0.3 mg and 0.5 mg strengths due to possible device failure; Bausch distributed the affected lots in Canada between April 2022 and May 2023

May 8, 2023 (press release) –

Summary

Product: Emerade epinephrine auto-injectors, 0.3 mg (DIN 02458446) and 0.5 mg (DIN 02458454)
Issue: Health products – Mechanical defect
What to do: Return your Emerade auto-injector to your pharmacy for a suitable replacement as soon as possible. Make sure you know how to use the replacement. Do not return or dispose of your Emerade auto-injector until a replacement is obtained. If a life-threatening allergic reaction (anaphylaxis) happens before you can get a replacement, use your recalled Emerade and then seek emergency medical attention.

Images

Affected products

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.

What you should do

• Contact your pharmacy to return your Emerade device and obtain a suitable replacement epinephrine auto-injector, as soon as possible. Keep your Emerade auto-injector until a replacement is obtained.
• 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.

Également disponible en français

SOURCE Health Canada

For further information: Media Enquiries: Health Canada, (613) 957-2983, media@hc-sc.gc.ca; Public Enquiries: (613) 957-2991, 1-866 225-0709, info@hc-sc.gc.ca

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