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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Completing and submitting the report online at www.fda.gov/medwatch/report.htm, or
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Downloading and completing the form, then submitting it via fax at 800-FDA-0178.
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