Drug recall D-0691-2017
Product
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.
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 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 ***
Recall details
- Recalling firm
- Meridian Medical Technologies a Pfizer Company, Brentwood, MO
- Quantity
- 92,544 2-pak (U.S.); 198,579 syringes (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