Epipen Recall

Mon, 04/03/2017 - 10:27am

Message from Health Services:
There has been a new national recall of Epipens in the United States.  Please see the press release below from Mylan.  The Health Services staff are currently identifying any assigned epipens in the health rooms for the affected Lot numbers.  Parents with the affected Epipens will be contacted for a replacement.  We WILL NOT discard of the Epipen while waiting for a replacement to be brought to the schools.  The affected Epipens will be returned to the families.  HCPSS Health Services is in contact with Mylan to obtain any necessary replacement for our STOCK Epipens as well.  Please feel free to contact with further questions your school health room staff directly.

This recall is being conducted as a result of the receipt of two previously disclosed reports outside of the U.S. of failure to activate the device due to a potential defect in a supplier component. The potential defect could make the device difficult to activate in an emergency (failure to activate or increased force needed to activate) and have significant health consequences for a patient experiencing a life-threatening allergic reaction (anaphylaxis). Both reports are related to the single lot that was previously recalled. The incidence of the defect is extremely rare and testing and analysis across the potentially impacted lots has not identified any units with a defect. However, the recall is being expanded to include additional lots as a precautionary measure out of an abundance of caution.

The recalled product was manufactured by Meridian Medical Technologies, a Pfizer company, and distributed by Mylan Specialty between December 2015 and July 2016. The expanded voluntary recall is being initiated in the U.S. and also will extend to additional markets in Europe, Asia, North and South America. The recall impacts the 0.3 mg and 0.15 mg strengths of EpiPen Auto-Injector. None of the recalled lots include the authorized generic for EpiPen Auto-Injector, which is also manufactured by Meridian Medical Technologies. U.S. Impacted Lots:  http://newsroom.mylan.com/2017-03-31-Mylan-Provides-Update-on-Meridian-Medical-Technologies-a-Pfizer-Company-Expanded-Voluntary-Worldwide-Recall-of-EpiPen-R-Auto-Injector