The U.S. Food and Drug Administration is alerting consumers to Meridian Medical Technologies’ voluntary recall//www.fda.gov/ucm/groups/fdagov-public/@system/documents/system/img_fdagov_exitdisclaimer.png" style="box-sizing: border-box; vertical-align: middle;"> of 13 lots of Mylan’s EpiPen and EpiPen Jr (epinephrine injection) Auto-Injector products used for emergency treatment of severe allergic reactions. This recall is due to the potential that these devices may contain a defective part that may result in the devices’ failure to activate. The recalled product was manufactured by Meridian Medical Technologies and distributed by Mylan Specialty.
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||May 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|