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)
Summary
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
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
- 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.
Additional information
Details
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
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