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Epipen Recall

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Epipen Recall

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
Source of recall: Health Canada
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

 

Updated on Wednesday, April 12, 2017.
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