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 Mylan at 800-796-9526 or customer.service@mylan.com with any questions.
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 | April 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 |
- Completing and submitting the report online at www.fda.gov/medwatch/report.htm, or
- Downloading and completing the form, then submitting it via fax at 800-FDA-0178.
Source: FDA