Voluntary recall of certain EpiPens

© alkerk/123RF.com
© alkerk/123RF.com
© alkerk/123RF.com
© alkerk/123RF.com

Voluntary recall of certain EpiPens

by: Stripes Staff | .
Stripes Europe | .
published: April 05, 2017

The FDA has issued a voluntary recall of certain EpiPen and EpiPen Jr. products. If you have one of the lot numbers identified by the FDA in the announcement below, bring the product to your clinic pharmacies for a replacement. If you have any questions or concerns please contact your clinic pharmacy.

The U.S. Food and Drug Administration is alerting consumers to Meridian Medical Technologies’ voluntary recall of 13 lots of Mylan’s EpiPen and EpiPen Jr. (epinephrine injection) Auto-Injector products used for emergency treatment of severe allergic reactions. This recall is due to the potential that these devices may contain a defective part that may result in the devices’ failure to activate. The recalled product was manufactured by Meridian Medical Technologies and distributed by Mylan Specialty.

While the number of reported failures is small, EpiPen products that potentially contain a defective part are being recalled because of the potential for life-threatening risk if a severe allergic reaction goes untreated. Consumers should keep and use their current EpiPens if needed until they get a replacement. Consumers should contact Mylan at 800-796-9526 or customer.service@mylan.com with any questions.

As stated on the product label, consumers should always seek emergency medical help right away after using their EpiPens, particularly if the device did not activate.

At this time, the 13 lots identified – distributed between Dec. 17, 2015, and July 1, 2016 – are the only EpiPen lots impacted by the U.S. recall. Consumers who have EpiPens from lots that are not included in this recall, do not need to replace their EpiPen prior to its expiration date.

Product/DosageNDC NumberLot NumberExp. Date
EpiPen Jr Auto-Injector, 0.15 mg49502-501-025GN767April 2017
EpiPen Jr Auto-Injector, 0.15 mg49502-501-025GN773April 2017
EpiPen Auto-Injector, 0.3 mg49502-500-025GM631April 2017
EpiPen Auto-Injector, 0.3 mg49502-500-025GM640May 2017
EpiPen Jr Auto-Injector, 0.15 mg49502-501-026GN215Sept. 2017
EpiPen Auto-Injector, 0.3 mg49502-500-026GM082Sept. 2017
EpiPen Auto-Injector, 0.3 mg49502-500-026GM072Sept. 2017
EpiPen Auto-Injector, 0.3 mg49502-500-026GM081Sept. 2017
EpiPen Auto-Injector, 0.3 mg49502-500-026GM088Oct. 2017
EpiPen Auto-Injector, 0.3 mg49502-500-026GM199Oct. 2017
EpiPen Auto-Injector, 0.3 mg49502-500-026GM091Oct. 2017
EpiPen Auto-Injector, 0.3 mg49502-500-026GM198Oct. 2017
EpiPen Auto-Injector, 0.3 mg49502-500-026GM087Oct. 2017


 

Tags: FDA, Recall, EpiPen, voluntary
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