EpiPen expands recall to United States

(Image: MGN Online)

Mylan, the makers of EpiPen, announced Friday they have expanded the voluntary recall of EpiPens.

The recall is a result from a defect in the auto injector. The company said they have had two reports of the auto injectors not working outside the U.S. The potential defect could make the device difficult to activate in an emergency and have significant health consequences for a patient experiencing a life-threatening allergic reaction.

Testing of the potentially impacted lots has not identified any units with the defect. Mylan said the recall is being expanded as a precautionary measure.

The recalled product was manufactured and distributed between December 2015 and July 2016. The expanded voluntary recall is being initiated in the U.S. and also will extend to markets in Europe, Asia, North and South America.

Patients, customers and distributors should refer to Mylan.com/EpiPenRecall for updates on product return and replacement instructions. Mylan is asking patients to keep their existing product until their replacement product can be secured.

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

For more information on the recall, click here.