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 labe
Check against the official notice below — it lists the full affected range.
Meridian Medical Technologies, a Pfizer company, is recalling specific lots of EpiPen 2-Pak epinephrine auto-injectors (0.3 mg) due to a defective delivery system that may prevent the devices from activating when needed. This could result in patients not receiving their medication during an emergency. The recall affects 373,960 2-paks distributed in the United States and Puerto Rico, as well as 331,738 auto-injectors distributed internationally across numerous countries including Canada, most European nations, Australia, Japan, and others.
The recalled U.S. lots include products with expiration dates ranging from April 2017 through October 2017, identified by lot numbers 5GM631, 5GM640, 6GM072, 6GM081, 6GM082, 6GM087, 6GM088, 6GM091, 6GM198, and 6GM199. International lots with expiration dates from April through October 2017 are also affected. The recall record does not specify a remedy or required action for 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: 373,960 2-paks (U.S.) ; 331,738 auto-injectors (O.U.S.) Lot/code info: 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.
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.