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
Media and public enquiries

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

Get notified

Receive notifications for new and updated recalls and alerts by category.

Subscribe