Anti-allergy medicine EpiPen recall expands to US

In this Friday, July 8, 2016 photo, a pharmacist holds a package of EpiPens, an epinephrine autoinjector for the treatment of allergic reactions, in Sacramento, Calif. (AP Photo/Rich Pedroncelli)

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 should refer to Mylan.com/EpiPenRecall.

U.S. Impacted Lots:

Product/Dosage

NDC Number

Lot Number

Expiration Date

EpiPen Jr 2-Pak® Auto-Injectors, 0.15 mg

49502-501-02

5GN767

April 2017

EpiPen Jr 2-Pak® Auto-Injectors, 0.15 mg

49502-501-02

5GN773

April 2017

EpiPen 2-Pak® Auto-Injectors, 0.3 mg

49502-500-02

5GM631

April 2017

EpiPen 2-Pak® Auto-Injectors, 0.3 mg

49502-500-02

5GM640

May 2017

EpiPen Jr 2-Pak® Auto-Injectors, 0.15 mg

49502-501-02

6GN215

September 2017

EpiPen 2-Pak® Auto-Injectors, 0.3 mg

49502-500-02

6GM082

September 2017

EpiPen 2-Pak® Auto-Injectors, 0.3 mg

49502-500-02

6GM072

September 2017

EpiPen 2-Pak® Auto-Injectors, 0.3 mg

49502-500-02

6GM081

September 2017

EpiPen 2-Pak® Auto-Injectors, 0.3 mg

49502-500-02

6GM088

October 2017

EpiPen 2-Pak® Auto-Injectors, 0.3 mg

49502-500-02

6GM199

October 2017

EpiPen 2-Pak® Auto-Injectors, 0.3 mg

49502-500-02

6GM091

October 2017

EpiPen 2-Pak® Auto-Injectors, 0.3 mg

49502-500-02

6GM198

October 2017

EpiPen 2-pak® Auto-Injectors, 0.3 mg

49502-500-02

6GM087

October 2017

 


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