If you have an unexpired EMERADE® auto-injector return it to your pharmacy
Voluntary recall by Bausch Health, Canada with Health Canada
If you have unexpired EMERADE® epinephrine auto-injectors, return them to your pharmacy as soon as possible.
There are other epinephrine auto-injectors available through pharmacies across Canada.
EMERADE® Sterile Epinephrine Injection is indicated for the emergency treatment of severe allergic reactions (anaphylaxis) triggered by allergens in foods, medicines, insect stings or bites, and other allergens and for exercise-induced or idiopathic anaphylaxis.
Bausch Health, Canada chose to initiate this voluntary action due to the potential risk that the auto-injector may fail to activate or activate prematurely if dropped. The decision to conduct this voluntary recall is part of our ongoing commitment to ensuring all our products meet the highest standards of quality. We take matters such as this very seriously, which is why we are taking this recall action.
The company has informed Health Canada about this action and is implementing their recommended recall protocols.
Communications have been issued to wholesalers and pharmacists across Canada to immediately stop all sales of EMERADE® and information about this recall has also been communicated to doctors.
If you have questions about this voluntary recall or would like additional information, please contact Bausch Health, Canada Inc. Customer Service at 1-800-361-4261.
For patients exceeding 60 kg, the recommended dose is 0.3 to 0.5 mg depending on clinical judgement.
Designed to minimize the risk of unintentional injection. Emerade™ should be used for intramuscular injection only on the outer thigh.
* Comparative significance is unknown.
† See Product Monograph for complete dosing and administration instructions.
Emerade™ is indicated for the emergency treatment of anaphylactic reactions in patients who are determined to be at increased risk for anaphylaxis, including individuals with a history of anaphylactic reactions. Select dose according to patient’s body weight and age.
Click here for complete safety information.
For adult patients exceeding 60 kg body weight, the recommended dose is 0.3 to 0.5 mg depending on clinical judgement. For adult patients under 60 kg, the recommended dose is 0.3 mg. For a child that weighs over 30 kg, the recommended dose is 0.3 mg.
In children:
In adults:
For adult patients exceeding 60 kg body weight, the recommended dose is 0.3 to 0.5 mg depending on clinical judgement. For adult patients under 60 kg, the recommended dose is 0.3 mg. For a child that weighs over 30 kg, the recommended dose is 0.3 mg.
The syringe in Emerade™ has a 25 mm needle. The needle protrudes 23 mm for intramuscular injection in the 0.3 mg and 0.5 mg pen. The needle length enables injection through clothing.
Emerade™ has a durable, plastic outer case to protect the auto-injector and labelling.
It is also labelled with different colours to distinguish the different dosages.
Emerade™ is available in a pack size of one pre-filled pen.
You can always sign up to receive a free trainer device so that you can show your patients.
You can also instruct your patients or caregivers to watch the online video to learn more.
You can also refer to the Instructions for use section in the Product Monograph for complete administration information.
Emerade™ can be purchased with or without a prescription.
It is recommended that patients carry 2 epinephrine auto-injectors, like Emerade™, at all times.
The first dose should be administered as soon as symptoms of anaphylaxis are recognized.
If there is no resolution of anaphylaxis, a second injection with an additional Emerade™ may be administered 5 – 15 minutes after the first injection.
Refer to the video to see how patients or caregivers can administer their Emerade™.
You can also refer to the Instructions for use section in the Product Monograph for complete administration information.
When the injection is completed, the plunger is visible in the inspection window by lifting the label. Some liquid may remain in the auto-injector after the injection. The auto-injector cannot be re-used.
To use Emerade™, gently press it against the outer side of the thigh. A click can be heard when the injection goes into the muscle.
During injection, Emerade™ is held against the thigh for about 5 seconds.
Store at room temperature (15°C to 25°C), do not freeze and keep it out of reach and sight of children.
EMERADE® is used for the emergency treatment of a sudden, severe, and life-threatening allergic reaction. This type of severe reaction is called anaphylaxis. EMERADE® is used in people:
It is used to treat people with severe allergies to:
The company has chosen to initiate this voluntary action due to the potential risk that the auto-injector may fail to activate or activate prematurely if dropped. This decision is part of the company’s ongoing commitment to ensuring all of its products meet the highest standards of quality. Bausch Health, Canada takes matters such as this very seriously, which is why this action has been taken promptly after coming to light.
A risk to the patient's health cannot be excluded. Failure to activate is evaluated as life-threatening, which is why Bausch Health has voluntarily decided to make this recall, to the patient level, meaning patients with EMERADE® should return it to their pharmacy.
We don’t believe the probability is high but are taking this action to protect Canadians who have EMERADE® and might need to use it.
No, the potential risk is that when EMERADE® is dropped and will be needed by someone having an anaphylactic reaction that the device might not activate and not deliver the epinephrine dose.
This affects all non-expired inventory of EMERADE® in Canada. Bausch Health, Canada has asked wholesalers and pharmacists to immediately stop all sales of EMERADE®. Individuals in possession of non-expired EMERADE® auto-injectors should return them to their pharmacy.
Health Canada has been fully informed in accordance with the required procedures for drug recalls in Canada.
There are other epinephrine auto-injectors available through pharmacies across Canada.
There are other epinephrine auto-injectors available through pharmacies across Canada. The patient should speak with their doctor to determine which epinephrine auto-injector is right for them. If the patient is not seeking public or private insurance coverage for their epinephrine auto-injector, they can acquire a different type of auto-injector directly from the pharmacy. However, if they have public or private insurance coverage, they will require a new prescription from their doctor for a different replacement.
Our priority at present is to focus on the recall. Therefore, we cannot comment on availability at this time.
Emerade™ is indicated for the emergency treatment of anaphylactic reactions in patients who are determined to be at increased risk for anaphylaxis, including individuals with a history of anaphylactic reactions. Select dose according to patient’s body weight and age.
Emerade™ is intended for immediate self-administration for emergency treatment of severe allergic reactions (Type I), including anaphylaxis associated with e.g. peanuts, tree nuts, shellfish, fish, milk, eggs, wheat, stinging insects, and medications.
Emerade™ is designed as emergency supportive therapy only and not as a replacement or substitute for subsequent medical care.
Emergency treatment: In conjunction with the administration of epinephrine, the patient should seek immediate medical or hospital care.
Following treatment of anaphylaxis, the patient must stay within close proximity to a hospital or where he or she can call 911 for the next 48 hours.
No absolute contraindications to the use of epinephrine in a life-threatening allergic situation.
Please consult the Product Monograph at: pdf.hres.ca/dpd_pm/00055405.PDF for important information relating to adverse reactions, drug interactions and dosing information which has not been discussed in this piece. The Prescribing Information is also available by calling us at: 1-800-361-4261.