FDANews
FDAnews Device Daily Bulletin

EpiPen Recalled Due to Administration Defect

March 27, 2017

Meridian Medical Technologies issued an international recall for its EpiPen auto-injectors, because the devices may contain a defective part that could cause a failure to activate or require increased force to activate.

Two reports have been confirmed of the device failing to activate, from a batch of approximately 80,000 devices. The recall was for one lot (#5FA665) of branded EpiPen Auto-Injectors, not the generic product. The lot was distributed to Australia, New Zealand, Europe and Japan only.

The company said batch numbers: 5FA665, 5FA6651, 5FA6652 or 5FA6653, with an expiration date of April 17, need to be replaced as soon as possible.

The device treats anaphylaxis, which can be life-threatening. — Cynthia Jessup

View today's stories

 

Updated: March 27, 2017 at 2:03 p.m.