FDAClass IMay 10, 2017

EpiPen 2-Pak recall

EpiPen 2-Pak (Epinephrine) Auto-Injectors 0.3 mg, Rx only, Manufactured for Mylan Specialty L.P., Morgantown WV 26505 by Meridian Medical…

Why was EpiPen 2-Pak recalled?

Defective Delivery System; reports of the device failing to activate which could result in a patient not receiving medication

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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.

Product
EpiPen 2-Pak (Epinephrine) Auto-Injectors 0.3 mg, Rx only, Manufactured for Mylan Specialty L.P., Morgantown WV 26505 by Meridian Medical…
Recalling firm
Meridian Medical Technologies a Pfizer Company
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.
Recall date
May 10, 2017
Classification
Class I
Status
Ongoing
Agency
FDA (drug)
Open FDA enforcement record Latest recalls