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