FDAFDA · Food and drugs·Recall number D-0690-2017
EpiPen 2-Pak (Epinephrine) Auto-Injectors 0.3 mg, Rx only, Manufactured for Mylan Specialty L.P., Morgantown WV 26505 by Meridian Medical Technologies, Inc., Columbia, MD 21046, a Pfizer company; NDC 49502-500-02 ---- ALSO LABELED OUTSIDE THE US AS ---- Epipen Auto-Injector 0.3 mg -Bright Stock labeled for multiple countries- manufactured for Mylan by Meridian Medical Technologies, Inc., Columbia, MD 21046, a Pfizer company.
Published May 10, 2017 · Recall initiated: March 12, 2017
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Defective Delivery System; reports of the device failing to activate which could result in a patient not receiving medication
What to do
Voluntary: Firm initiated · Press Release
Recall details
- Brand
- EPIPEN
- Manufacturer
- Meridian Medical Technologies a Pfizer Company
- Distributor
- Nationwide and Puerto Rico, Argentina, Austria, Australia, Belgium, Chile, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Ireland, Italy, Japan, Latvia, Lithuania, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Saudi Arabia, Singapore, Slovakia, Slovenia, Sweden, Switzerland, Taiwan, Thailand, United Kingdom. There has been no U.S. government or military distribution.
- Lot
- US: lot 5GM631, exp. April 2017; lot 5GM640, exp. May 2017; lot 6GM072, exp. Sep 2017; lot 6GM082, exp. Sep 2017; lot 6GM088, exp. Oct 2017; lot 6GM087, exp. Oct 2017; lot 6GM198, exp. Oct 2017; lot 6GM081, exp. Sep 2017; lot 6GM091, exp. Oct 2017; lot 6GM199, exp. Oct 2017: INTERNATIONAL: lot 5FA665, exp. April 2017; lot 5GU763, exp. May 2017; lot 6FA293, exp. Oct 2017; lot 6FA292, exp. Oct 2017; lot 6GH294, exp. Oct 2017.
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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