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
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.
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