This month, the U.S. Food and Drug Administration alerted consumers to Meridian Medical Technologies’ voluntary recall of 13 lots of Mylan’s EpiPen and EpiPen Jr (epinephrine injection) Auto-Injector products, which are commonly used for emergency treatment of serious allergic reactions. The main reason for the recall is because of the possibility that these devices may contain a defective part, which may result in failure to activate.
Although the number of reported failures are minuscule, EpiPen produces which potentially contain a defective function are being recalled due to the possibility of life-threatening risk in the event of a severe allergic reaction. The 13 lots identified were distributed between December 17, 2015, and July 1, 2016, and only affect the United States.
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 |
The FDA requests any consumers and healthcare providers to report any adverse reactions or device malfunctions to the FDA’s MedWatch program by either:
- Completing and submitting the report online at www.fda.gov/medwatch/report.htm
- Downloading and completing the form, then submitting it via fax at 800-FDA-0178.
If you suffered an injury caused by a defective medical product in Weston, contact Rash Mueller. today.