The Food and Drug Administration has issued a recall of 13 lots of EpiPen and EpiPen Jr. due to a potential defect.
The recalled devices may contain a defective part that could cause the pens to fail to activate. The recalled product was manufactured by Meridian Medical Technologies and distributed by Mylan Specialty, the FDA said.
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The FDA said the number of reported failures is small, but the lots are being recalled because failure to activate and treat a severe allergic reaction is a life-threatening risk.
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The affected lots are:
EpiPen Jr Auto-Injector, 0.15 mg NDC Number: 49502-501-02 Lot Number: 5GN767 Expires: April 2017
EpiPen Jr Auto-Injector, 0.15 mg NDC Number: 49502-501-02 Lot Number: 5GN773 Expires: April 2017
EpiPen Jr Auto-Injector, 0.15 mg NDC Number: 49502-501-02 Lot Number: 6GN215 Expires: September 2017
EpiPen Auto-Injector, 0.3 mg NDC Number: 49502-500-02 Lot Number: 5GM631 Expires: April 2017
EpiPen Auto-Injector, 0.3 mg NDC Number: 49502-500-02 Lot Number: 5GM640 Expires: May 2017
EpiPen Auto-Injector, 0.3 mg NDC Number: 49502-500-02 Lot Number: 6GM082 Expires: September 2017
EpiPen Auto-Injector, 0.3 mg NDC Number: 49502-500-02 Lot Number: 6GM072 Expires: September 2017
EpiPen Auto-Injector, 0.3 mg NDC Number: 49502-500-02 Lot Number: 6GM081 Expires: September 2017
EpiPen Auto-Injector, 0.3 mg NDC Number: 49502-500-02 Lot Number: 6GM088 Expires: October 2017
EpiPen Auto-Injector, 0.3 mg NDC Number: 49502-500-02 Lot Number: 6GM199 Expires: October 2017
EpiPen Auto-Injector, 0.3 mg NDC Number: 49502-500-02 Lot Number: 6GM091 Expires: October 2017
EpiPen Auto-Injector, 0.3 mg NDC Number: 49502-500-02 Lot Number: 6GM198 Expires: October 2017
EpiPen Auto-Injector, 0.3 mg NDC Number: 49502-500-02 Lot Number: 6GM087 Expires: October 2017
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AP
FILE - This Oct. 10, 2013, file photo, shows an EpiPen epinephrine auto-injector, a Mylan product, in Hendersonville, Texas. (AP Photo/Mark Zaleski, File)