Nationwide Recall for EpiPen

If you own and use the life-saving allergy shot, EpiPen, it is imperative to check the lot number on the side of the box. Mylan, the manufacturer of EpiPens and EpiPen Jr. Auto-Injector, is calling for a voluntary, nationwide recall of specific models due to failing to work/activate properly and may not deploy medication effectively.

“The potential defect could make the device difficult to activate in an emergency and have significant consequences for a patient experiencing a life-threatening allergic reactions (anaphylaxis),” the company announced in a statement last week.

The recall affects certain lots of the 0.3 mg and 0.15 mg strengths of EpiPen Auto-Injector. However, none of the recalled lots include the authorized generic for EpiPen Auto-Injector, which is also manufactured by Meridian Medical Technologies, a Pfizer company and Mylan’s manufacturing partner for the device.

The following is a list of U.S. Impacted Lots:

Product/Dosage

NDC Number on Carton

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

Defective pens will be replaced at pharmacies throughout the country. Consumers must contact Mylan directly by calling (800) 796-9526 or emailing customer.service@mylan.com prior to obtaining a new pen. Both Mylan and the FDA insist that consumers keep their defective pens – in the event of an emergency – until they have received replacements since not every single unit from the 13 lots is malfunctioning.

If you suffered a serious injury due to a defective medical device or product, contact Simeone & Miller and request a free consultation with our Washington DC personal injury attorney today.

Categories: Product Liability