Last month, the U.S. Food and Drug Administration (FDA) alerted consumers to Meridian Medical Technologies’ voluntary recall of 13 lots of Mylan’s EpiPen and EpiPen Jr Auto-Injector products used for emergency treatment of serious allergic reactions. The recall has been administered due to the possibility that these devices may have a defect that leads to the devices’ failure to activate.
Although the number of reported failures is minimal, EpiPen devices which potentially contain a defective part are being recalled due to the potential for life-threatening risk if a serious allergic reaction is left untreated. Distributed between December 17, 2015 and July 1, 2015, the 13 lots identified are the only EpiPen lots affected by the U.S. recall. Those who have EpiPens from lots that are not included in this recall do not need to replace their EpiPen.
Here is the 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 |
The FDA asks medical professional and consumers to report any adverse reactions or device malfunctions to the FDA’s MedWatch program by reporting it online at www.fda.gov/medwatch/report.htm.
If you suffered an injury caused by a defective medical device or product, contact our Louisville medical malpractice attorney at Brett H. Oppenheimer, PLLC today.