Meridian Medical Technologies – maker of Mylan’s EpiPen injector – has issued a voluntary nationwide recall of EpiPen and EpiPen Jr.
The U.S. Food and Drug Administration said the recall is due to the possibility that defective parts could result in the pens failing to activate. According to the FDA although 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.
The FDA is advising consumers to keep and use their current EpiPens if needed until they get a replacement. They are also advised to follow directions on the product label and seek emergency medical help immediately after using an EpiPen, especially if their device didn’t activate.
The affected lots were distributed in the U.S. between December 17th of 2015 and July 1st, 2016.
Mylan will replace any of the affected devices free of charge.
Consumers should contact Mylan at 1-800-796-9526 or customer.service@mylan.com with any questions.
(al.com/www.al.com)
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 |