This month, the U.S. Food and Drug Administration (FDA) alerted the public about Meridian Medical Technologies’ voluntary recall of 13 lots of Mylan’s EpiPen and EpiPen Jr. Auto-Injector products, which is commonly used for emergency treatment of severe allergic reactions. The reason for the recall is that the affected devices may contain a defect which results in failure to activate.
While there are only a few reports of this specific failure, EpiPen devices that possibly have a defective part are being recalled because of the life-threatening risk if a serious allergic reaction is not treated in a timely manner. The 13 lots identified have been distributed between December 17, 2015 and July 1, 2015.
The following is a list of the 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 |
Those who have EpiPens from lots which are not included in the list do not need to have their product replaced. If you have one of these lots in your possession, report it to the FDA online at www.fda.gov/medwatch/report.htm.
If you suffered an injury caused by a defective product in Missouri, contact our Kansas City product liability attorney at Bertram & Graf, L.L.C. today.