Public advisory - 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

OTTAWA, ON, May 5, 2023 /CNW/ -

Brand(s)
Emerade

Emerade 0.3 mg (CNW Group/Health Canada)

Emerade 0.5 mg (CNW Group/Health Canada)

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

Product	DIN	Lot Number	Expiration Date
Emerade 0.3 mg	02458446	Y0225B2A	2023-05-31
Emerade 0.3 mg	02458446	Z0076B1A	2023-08-30
Emerade 0.3 mg	02458446	Z0034B2C	2023-06-30
Emerade 0.3 mg	02458446	Z0198B3A	2024-10-31
Emerade 0.3 mg	02458446	Z0198B3B	2024-10-31
Emerade 0.5 mg	02458454	Y0225C1A	2023-05-31
Emerade 0.5 mg	02458454	Z0034C1A	2023-06-30
Emerade 0.5 mg	02458454	Z0076C2A	2023-08-30
Emerade 0.5 mg	02458454	Z0088C3A	2023-08-30
Emerade 0.5 mg	02458454	Z0153C2A	2024-08-31
Emerade 0.5 mg	02458454	Z0236C1C	2024-11-30
Emerade 0.5 mg	02458454	Z0088C3B	2023-08-31
Emerade 0.5 mg	02458454	Z0128C1B	2024-05-31
Emerade 0.5 mg	02458454	Z0153C2B	2024-08-31

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 [email protected] , 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

Media Enquiries: Health Canada, [phone], [email protected]; Public Enquiries: [phone], 1-866 225-0709, [email protected]