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 Stoc
Check against the official notice below — it lists the full affected range.
Meridian Medical Technologies issued a recall of EpiPen Jr. 2-Pak auto-injectors (0.15 mg epinephrine) due to a defective delivery system. The company received reports that the devices failed to activate, which could prevent patients from receiving their medication. The affected products were distributed nationwide in the United States and Puerto Rico, as well as internationally across numerous countries including Canada, Europe, Asia, and other regions.
The recall involved 92,544 two-packs distributed in the U.S. and 198,579 syringes distributed outside the U.S. The affected lots include U.S. lots 5GN767, 5GN773, and 6GN215 (with expiration dates ranging from April to September 2017), and international lots 5GR765, 5GK771, 5ED824, and 6ED117 (expiring between March and April 2017). The source document does not specify a remedy or instructions for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Defective Delivery System; reports of the device failing to activate which could result in a patient not receiving medication
Reason for recall: Defective Delivery System; reports of the device failing to activate which could result in a patient not receiving medication 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 distrib Quantity: 92,544 2-pak (U.S.); 198,579 syringes (O.U.S.) Lot/code info: 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 ***
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.