Pfizer Canada recalls two lots of EpiPen / EpiPen Jr auto-injectors (0.3 mg and 0.15 mg epinephrine) due to possible device failure

Starting date:

April 1, 2017

Type of communication:

Advisory

Subcategory:

Drugs

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public

Identification number:

RA-62872

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  Issue
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  Products affected
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  What you should do
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  Who is affected
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  Media enquiries
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  Public enquiries
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  What Health Canada is doing
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  Images

Issue

Pfizer Canada, in consultation with Health Canada, is voluntarily recalling one lot of EpiPen auto-injector and one lot of EpiPen Jr. auto-injector. The recalled devices may contain a defective part that may result in the auto-injector failing to activate or requiring increased force to activate.

This recall is being conducted following two confirmed international reports of the device failing to activate. There have been no confirmed reports of device failures involving lots distributed in Canada.

EpiPen/EpiPen Jr. auto-injectors are used to deliver an emergency treatment of adrenaline (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 adrenaline (epinephrine), resulting in the worsening of symptoms of anaphylaxis or anaphylactic reactions, which could be life threatening.

Products affected

• EpiPen (0.3 mg epinephrine) auto-injector lot 5GU763, expiry date May 2017, 67844 units distributed in Canada
• EpiPen Jr (0.15 mg epinephrine) auto-injector lot 5GR765, expiry date March 2017, 39503 units distributed in Canada

What you should do

• Patients and caregivers should check whether they have the affected device.
• Contact your pharmacy to arrange return of your EpiPen/EpiPen Jr. device and obtain a replacement as soon as possible.
• Pfizer Canada is also advising patients and caregivers to keep the affected EpiPen/EpiPen Jr. auto-injectors until a replacement is obtained.
• In the event that a life-threatening allergic reaction (anaphylaxis) occurs before you can obtain a replacement, use your EpiPen/EpiPen Jr. product as directed by your healthcare provider and then seek emergency medical attention.
• Speak with your healthcare professional if you are concerned about your health.
• Contact Pfizer Canada at 1-866-9Pfizer (1-866-973-4937) or CorporateAffairsCanada@pfizer.com for more information on the recall.
• Report adverse events to health products to Health Canada by calling toll-free at 1-866-234-2345, or by reporting online, by mail or by fax.
• Report complaints about health products to Health Canada by calling toll-free at 1-800-267-9675, or complete an online complaint form.

Who is affected

• Patients and caregivers who have the affected device

Media enquiries

Health Canada

(613) 957-2983

Public enquiries

(613) 957-2991

1-866 225-0709

What Health Canada is doing

Health Canada is monitoring the company’s recall. If new safety information is identified, Health Canada will take appropriate action and inform Canadians.

Images

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