Recalls / Class I

Class ID-0690-2017

Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.

Product

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.

Brand name: Epipen
Generic name: Epinephrine
Active ingredient: Epinephrine
Route: Intramuscular
NDCs: 49502-500, 49502-501
FDA application: NDA019430
Affected 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.

Why it was recalled

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

Recalling firm

Firm: Meridian Medical Technologies a Pfizer Company
Manufacturer: Viatris Specialty LLC
Notification channel: Press Release
Type: Voluntary: Firm initiated
Address: 2555 Hermelin Dr, Brentwood, Missouri 63144-2504

Distribution

Quantity: 373,960 2-paks (U.S.) ; 331,738 auto-injectors (O.U.S.)
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.

Timeline

Recall initiated: 2017-03-12
FDA classified: 2017-04-28
Posted by FDA: 2017-05-10
Status: Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-0690-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.