RECALL POSTED March 31, 2017:
From Pfizer Canada: The Canadian distributor of EpiPen (epinephrine) Auto-Injector announced a voluntary recall of one lot of EpiPen 0.3 mg (epinephrine) and one lot of EpiPen Jr 0.15 mg (epinephrine) Auto-Injectors distributed in Canada. In Canada, the recall impacts one lot (5GU763) of the 0.3 mg strength of EpiPen Auto-Injector expiring in May 2017 and one lot (5GR765) of the 0.15 mg strength of EpiPen Jr Auto-Injector expiring in March 2017.
Pfizer says the recalled 0.3 EpiPens were distributed from January to March 2016, and the 0.15 EpiPen Jr were distributed November 2015 to February 2016.
Pfizer and Health Canada decided to issue the recall as the result of two previously disclosed reports outside of Canada of failure to activate the device due to a potential defect in a supplier component. The potential defect could make the device difficult to activate in an emergency (failure to activate or increased force needed to activate) and have significant health consequences for a patient experiencing a life-threatening allergic reaction (anaphylaxis). The incidence of the defect is extremely rare and testing and analysis across the potentially impacted lots has not identified any units with a defect. However, the recall is being conducted in Canada out of an abundance of caution.
Pfizer Canada is committed to replacing recalled devices at no cost. Patients, healthcare professionals, wholesalers and pharmacists are being notified.
Pfizer also advises that patients should keep their existing product until their replacement product can be secured. Additional stock is being created to meet demand in the coming weeks.
Consumers with questions regarding the recall can contact Pfizer Medical Information at 1-800-463-6001 between 9:00 a.m. and 5:00 p.m. EST.
Adverse reactions to the EpiPen or quality problems may be reported to 1-866-723-7111. Reports can be made directly to Health Canada as well through the Canada Vigilance Program at 1-866-234-2345.
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