FDA alerts consumers of nationwide voluntary recall of EpiPen and EpiPen Jr

The U.S. Food and Drug Administration is alerting consumers to Meridian Medical Technologies’ voluntary recall 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.

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 Stericycle at 877-650-3494.

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.

Please visit https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm550170.htm for more information.

Food Allergies/Anaphylaxis 

Anaphylaxis is a sudden, life threatening, severe allergic reaction. The most dangerous symptoms include breathing difficulties, a drop in blood pressure or shock. While New Caney ISD cannot guarantee an allergy-free environment at school, the district is committed to doing everything possible to ensure the safety of every child who has allergies.

New Caney ISD has developed guidelines to manage students with these life threatening allergies so that they may safely participate in the educational process. Students who are at risk for developing anaphylaxis are entitled to carry and self-administer their anaphylaxis medications (epinephrine auto-injectors) while at school or a school event (see medication policy for Self-Administration guidelines).

If your child has food allergies of any kind, please notify the school nurse prior to or upon registration of your child.  School district policy requires the Child Nutrition Department to maintain a Physician's Statement form (see attached) for each student diagnosed with food allergies in order to provide the necessary modifications.  In addition, your physician should provide a Food Allergy Action Plan or Anaphylaxis Action Plan (if allergen is non-food related) to be kept on file in the school clinic. Both of these forms must be renewed annually.  If you have any questions, please contact the school nurse.


 
 
 
 
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