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.”
|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:
- 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.
Do you manufacture an FDA-regulated drug or medical device? We can help ensure that your products are manufactured in compliance with all of FDA’s regulations and Good Manufacturing Practices (GMPs). To learn more about our services and how we can help you, contact us today.
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