Drug recall D-0690-2017
Product
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.
Reason for recall
Defective Delivery System; reports of the device failing to activate which could result in a patient not receiving medication
Lots and codes
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.
Recall details
- Recalling firm
- Meridian Medical Technologies a Pfizer Company, Brentwood, MO
- Quantity
- 373,960 2-paks (U.S.) ; 331,738 auto-injectors (O.U.S.)
- Distribution
- 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.
- Type
- Voluntary: Firm initiated
- Recall initiated
- March 12, 2017
Related products
- Epipen – drug information
- NDC 49502-500 Epipen · Epinephrine .3 mg/.3mL · Viatris Specialty LLC
- NDC 49502-501 Epipen Jr · Epinephrine .15 mg/.3mL · Viatris Specialty LLC