Home / Recalls / Meridian Medical Technologies a Pfizer Company / D-0690-2017

D-0690-2017 Class I Ongoing

Recalled by Meridian Medical Technologies a Pfizer Company — Brentwood, MO

FDA drug recall D-0690-2017 was initiated by Meridian Medical Technologies a Pfizer Company on March 12, 2017 and is designated Class I. Reason for recall: Defective Delivery System; reports of the device failing to activate which could result in a patient not receiving medication The recall status is ongoing. Affected quantity: 373,960 2-paks (U.S.) ; 331,738 auto-injectors (O.U.S.).

Recall Details

Product Type: Drugs
Report Date: May 10, 2017
Initiation Date: March 12, 2017
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 373,960 2-paks (U.S.) ; 331,738 auto-injectors (O.U.S.)

Product Description

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

Distribution Pattern

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.

Code Information

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.