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FDA alerts consumers of nationwide voluntary recall of EpiPen and EpiPen Jr

Posted 8 months ago by Annette Johansen

The U.S. Food and Drug Administration is alerting consumers to Meridian Medical Technologies’ voluntary recall of 13 lots of Mylan’s EpiPen and EpiPen Jr (epinephrine injection) Auto-Injector products used for emergency treatment of severe allergic reactions. This recall is due to the potential that these devices may contain a defective part that may result in the devices’ failure to activate. The recalled product was manufactured by Meridian Medical Technologies and distributed by Mylan Specialty.

While the number of reported failures is small, EpiPen products that potentially contain a defective part are being recalled because of the potential for life-threatening risk if a severe allergic reaction goes untreated. Consumers should keep and use their current EpiPens if needed until they get a replacement. Consumers should contact Stericycle at 877-650-3494.

As stated on the product label, consumers should always seek emergency medical help right away after using their EpiPens, particularly if the device did not activate.

At this time, the 13 lots identified – distributed between Dec. 17, 2015, and July 1, 2016 – are the only EpiPen lots impacted by the U.S. recall. Consumers who have EpiPens from lots that are not included in this recall, do not need to replace their EpiPen prior to its expiration date.

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

May 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

The FDA asks health care professionals and consumers to report any adverse reactions or device malfunctions to the FDA’s MedWatch program, by:

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.