| | 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 canada.customerservice@bauschhealth.com , if you have questions about the recall.
- Report any health product-related side effects or complaints to Health Canada.
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