FDA Announces Recall of EpiPen & EpiPen Jr.

FDA Announces Voluntary Recall of 13 Lots of EpiPen & EpiPen Jr. Auto-Injector Products

On Friday, March 31st, the FDA informed consumers of “Meridian Medical Technologies’ voluntary recall of 13 lots of Mylan’s EpiPen and EpiPen Jr (epinephrine injection) Auto-Injector products.”  These products are used in emergency situations to treat severe allergic reactions.  The products being recalled are distributed by Mylan, but manufactured by Meridian Medical Technologies, who decided to recall the EpiPen’s came after learning that they “may contain a defective part that may result in the devices’ failure to activate.”

According to the FDA, the number of failures that have been reported is very small, however all of the EpiPen products that could potentially contain one of these defective parts is being recalled because of the life-threatening risks associated with a severe allergic reaction going untreated.  The Agency is advising consumers to keep and use their current EpiPens as needed until a replacement is received.  Additionally, as always, consumers are advised to seek emergency medical help immediately after using an EpiPen, especially if the device did not activate properly.

“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

 

FDA is asking consumers and health care professionals to report any adverse reactions or device malfunctions that are experienced when using an EpiPen to the FDA’s MedWatch program.  This can be done by:

  1. Completing and submitting the report online at www.fda.gov/medwatch/report.htm, or
  2. Downloading and completing the form, then submitting it via fax at 800-FDA-0178.
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