Health product recall

Emerade injection; Device failure

Brand(s)
Last updated

Summary

Product
Emerade Injection (0.3 mg / 0.3 mL and 0.5 mg / 0.5 mL)
Issue
Health products - Product quality
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

Brand Product Name Market Authorization Dosage Form Strength Lot number
Emerade Emerade 0.3 mg / 0.3 mL injection DIN 02458446 Solution Epinephrine bitartrate 0.3 mg / 0.3 mL Y0225B2A, Z0076B1A, Z0034B2C, Z0198B3A, Z0198B3B
Emerade Emerade 0.5 mg / 0.5 mL injection DIN 02458454 Solution Epinephrine bitartrate 0.5 mg / 0.5 mL Y0225C1A, Z0034C1A, Z0076C2A, Z0088C3A, Z0153C2A, Z0236C1C, Z0088C3B, Z0128C1B, Z0153C2B

Issue

Auto-injectors may be malfunctioning in affected lots.

Additional information

Background

Depth of recall: Users

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Drugs
Companies

Bausch Health, Canada Inc.
2150 St. Elzéar Blvd. West, 
Laval, Quebec, H7L 4A8, Canada

Published by
Health Canada
Audience
General public
Healthcare
Industry
Recall class
Type I
Identification number
RA-73637