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FDA announces nationwide voluntary recall of EpiPen and EpiPen Jr.

Potential defective parts
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The FDA announced Friday a nationwide recall of Mylan’s EpiPen and EpiPen Jr. auto-injector products used for allergic reactions.

The recall is due to a potential defective part that will not allow the device to activate  the life-saving drugs.

The number of reported failures is small, however, the FDA is recalling any products that may contain a defective part.

Consumers should keep and use their current EpiPens if needed until they can get a replacement.

The FDA has identified 13 lots distributed between Dec. 17, 2015 and July 1, 2016. If you have an EpiPen not from one of the following lots, you do not need to replace it.

 

Product/Dosage NDC Number Lot Number Expiration Date
EpiPen Jr Auto-Injector, 0.15 mg 49502-501-02 5GN767 April 2017
EpiPen Jr Auto-Injector, 0.15 mg 49502-501-02 5GN773 April 2017
EpiPen Auto-Injector, 0.3 mg 49502-500-02 5GM631 April 2017
EpiPen Auto-Injector, 0.3 mg 49502-500-02 5GM640 April 2017
EpiPen Jr Auto-Injector, 0.15 mg 49502-501-02 6GN215 September 2017
EpiPen Auto-Injector, 0.3 mg 49502-500-02 6GM082 September 2017
EpiPen Auto-Injector, 0.3 mg 49502-500-02 6GM072 September 2017
EpiPen Auto-Injector, 0.3 mg 49502-500-02 6GM081 September 2017
EpiPen Auto-Injector, 0.3 mg 49502-500-02 6GM088 October 2017
EpiPen Auto-Injector, 0.3 mg 49502-500-02 6GM199 October 2017
EpiPen Auto-Injector, 0.3 mg 49502-500-02 6GM091 October 2017
EpiPen Auto-Injector, 0.3 mg 49502-500-02 6GM198 October 2017
EpiPen Auto-Injector, 0.3 mg 49502-500-02 6GM087 October 2017
 

The FDA asks health care professionals and consumers to report any adverse reactions or device malfunctions to the FDA’s MedWatch program, by:

 

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