Mylan Recall In Canada And The U.S.: Check Lot Numbers

Mylan Recall In Canada And The U.S.: Check Lot Numbers

Canada is now part of a package of countries that are subject to a recall of epinephrine auto-injectors published following reports of defects that may prevent adequate dose administration.

The announcement of the recall occurs a few weeks after a first notice of two technical failures outside of Canada was issued.

The recall also concerns the United States and the countries of Europe, Asia and Latin America. Mylan, the pharmaceutical company responsible for marketing the EpiPen, did not want to confirm in the short term how many injectors were targeted by the recall overall.

In Canada, the recall involves a batch of EpiPen 0.3 mg (5GU763) auto-injectors expired May 2017, and a batch of 0.15 mg EpiPen Jr (5GR765) auto-injectors As expiry date March 2017.


EpiPen is used in the emergency treatment of severe allergic reactions. The deficiencies currently identified are related to triggering problems of the mechanism and can lead to fatal complications in a patient who experiences anaphylactic shock. Mylan argues, however, that such incidents remain “very rare”.

Earlier on Friday, Pfizer, which is responsible for distribution in Canada, said the country was not covered by the recall but eventually chose to apply the measure “in concert with Health Canada.”

The pharmaceutical industry maintains that the voluntary recall was set up only as a precautionary measure. Pfizer Canada is committed to replacing recalled auto-injecters free of charge and indicates that healthcare professionals, resellers and pharmacists are currently “aware of the process”.

Patients should keep the injector in their possession until they have access to the replacement product. They should normally receive this product at their pharmacy, depending on the availability of the stock.

However, Pfizer expects to receive additional inventory to meet the demand.

EpiPen users can obtain additional information by visiting the Pfizer website, the Pfizer Canada Facebook page, or the EpiPen Canada Facebook page. They can also contact the pharmaceutical company by phone at 1-800-463-6001.

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