FDAFDA · Food and drugs·Recall number D-0691-2017
EpiPen Jr. 2-Pak (Epinephrine) Auto-Injectors 0.15 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 Jr. 0.15 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 5GN767, expiration April 2017; lot 5GN773, expiration April 2017; lot 6GN215, expiration Sep 2017: INTERNATIONAL lot 5GR765, expiration March 2017; lot 5GK771, expiration April 2017; lot 5ED824, expiration April 2017; and lot 6ED117, expiration ***
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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