Recalls / Class I

Class ID-0691-2017

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 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 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 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 ***

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: 92,544 2-pak (U.S.); 198,579 syringes (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-0691-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.