Anti-allergy medicine EpiPen recall expands to U.S.

A recall of the emergency anti-allergy medicine EpiPen is expanding to the U.S. and other markets in North America, Europe, Asia and South America because the allergy shots may not work.

The notice issued Friday by Mylan N.V. expands upon warnings made earlier this month after two reports of the device failing.

Mylan didn't immediately respond to a question about how many devices are affected by the recall. The U.S. Food and Drug Administration says the recall covers 13 lots distributed from December 2015 through July 2016.

The problems could be potentially life-threatening, although Mylan described the incidence of the defects as "extremely rare."

The EpiPen is used to treat allergic reactions to certain food and bug bites.

The products can be replaced at no charge by calling 877-650-3494 or emailing customer.service@mylan.com.

Product/Dosage NDC Number Lot Number Expiration Date
EpiPen Jr Auto-Injector, 0.15 mg 49502-501-02 5GN767 April 2017
EpiPen Jr Auto-Injector, 0.15 mg 49502-501-02 5GN773 April 2017
EpiPen Auto-Injector, 0.3 mg 49502-500-02 5GM631 April 2017
EpiPen Auto-Injector, 0.3 mg 49502-500-02 5GM640 April 2017
EpiPen Jr Auto-Injector, 0.15 mg 49502-501-02 6GN215 September 2017
EpiPen Auto-Injector, 0.3 mg 49502-500-02 6GM082 September 2017
EpiPen Auto-Injector, 0.3 mg 49502-500-02 6GM072 September 2017
EpiPen Auto-Injector, 0.3 mg 49502-500-02 6GM081 September 2017
EpiPen Auto-Injector, 0.3 mg 49502-500-02 6GM088 October 2017
EpiPen Auto-Injector, 0.3 mg 49502-500-02 6GM199 October 2017
EpiPen Auto-Injector, 0.3 mg 49502-500-02 6GM091 October 2017
EpiPen Auto-Injector, 0.3 mg 49502-500-02 6GM198 October 2017
EpiPen Auto-Injector, 0.3 mg 49502-500-02 6GM087 October 2017

 

© 2017 Associated Press


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