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

Brand(s)
Last updated

Summary

Product
Emerade epinephrine auto-injectors, 0.3 mg (DIN 02458446) and 0.5 mg (DIN 02458454)
Issue
Health products - Other
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.

Affected products

Table
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.

Additional information

Details
Original published date:
Alert / recall type
Public advisory
Category
Health products
Companies
Published by
Health Canada
Audience
Identification number
RA-73621
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