Public recall detail

Emerade injection; Device failure

2023-05-08

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Recall Safety notice
Quick summary

Quick summary: Emerade injection; Device failure. Date: 2023-05-08.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Emerade injection; Device failure. Date: 2023-05-08.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandEmerade
ProductEmerade Injection (0.3 mg / 0.3 mL and 0.5 mg / 0.5 mL)
IssueHealth products - Product quality
Recall classType I
IdentificationRA-73637

Affected products

BrandEmerade
ProductEmerade 0.3 mg / 0.3 mL injection
DIN / NPN / authorizationDIN 02458446
Dosage formSolution
StrengthEpinephrine bitartrate 0.3 mg / 0.3 mL
LotY0225B2A, Z0076B1A, Z0034B2C, Z0198B3A, Z0198B3B
BrandEmerade
ProductEmerade 0.5 mg / 0.5 mL injection
DIN / NPN / authorizationDIN 02458454
Dosage formSolution
StrengthEpinephrine bitartrate 0.5 mg / 0.5 mL
LotY0225C1A, Z0034C1A, Z0076C2A, Z0088C3A, Z0153C2A, Z0236C1C, Z0088C3B, Z0128C1B, Z0153C2B

Issue

Auto-injectors may be malfunctioning in affected lots.

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 official information
AudienceGeneral public Healthcare Industry
CategoryHealth products - Drugs
CompaniesBausch Health, Canada Inc. 2150 St. Elzéar Blvd. West, Laval, Quebec, H7L 4A8, Canada
Published byHealth Canada
Recall classType I
Alert / recall typeHealth product recall
Identification numberRA-73637
Background{}
CompaniesBausch Health, Canada Inc. 2150 St. Elzéar Blvd. West, Laval, Quebec, H7L 4A8, Canada
AudiencesGeneral public Healthcare Industry
Source updated2023-05-08

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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