ACAAI has been informed by Mylan of the voluntary recall of certain lots of EpiPen and EpiPen Jr because of a potential defect could make the device difficult to activate in an anaphylactic emergency. The EpiPen and EpiPen Jr devices recalled were manufactured from December 2015 and July 2016. Please see the lots recalled below:
U.S. Impacted Lots:
Product/Dosage
|
NDC Number
|
Lot Number
|
Expiration Date
|
EpiPen Jr 2-Pak® Auto-Injectors, 0.15 mg
|
49502-501-02
|
5GN767
|
April 2017
|
EpiPen Jr 2-Pak® Auto-Injectors, 0.15 mg
|
49502-501-02
|
5GN773
|
April 2017
|
EpiPen 2-Pak® Auto-Injectors, 0.3 mg
|
49502-500-02
|
5GM631
|
April 2017
|
EpiPen 2-Pak® Auto-Injectors, 0.3 mg
|
49502-500-02
|
5GM640
|
May 2017
|
EpiPen Jr 2-Pak® Auto-Injectors, 0.15 mg
|
49502-501-02
|
6GN215
|
September 2017
|
EpiPen 2-Pak® Auto-Injectors, 0.3 mg
|
49502-500-02
|
6GM082
|
September 2017
|
EpiPen 2-Pak® Auto-Injectors, 0.3 mg
|
49502-500-02
|
6GM072
|
September 2017
|
EpiPen 2-Pak® Auto-Injectors, 0.3 mg
|
49502-500-02
|
6GM081
|
September 2017
|
EpiPen 2-Pak® Auto-Injectors, 0.3 mg
|
49502-500-02
|
6GM088
|
October 2017
|
EpiPen 2-Pak® Auto-Injectors, 0.3 mg
|
49502-500-02
|
6GM199
|
October 2017
|
EpiPen 2-Pak® Auto-Injectors, 0.3 mg
|
49502-500-02
|
6GM091
|
October 2017
|
EpiPen 2-Pak® Auto-Injectors, 0.3 mg
|
49502-500-02
|
6GM198
|
October 2017
|
EpiPen 2-pak® Auto-Injectors, 0.3 mg
|
49502-500-02
|
6GM087
|
October 2017
|
If you or your patients have any of the recalled auto-injectors, you should refer to
Mylan.com/EpiPenRecall for updates on product return and replacement instructions. Mylan will replace the recalled devices for free and is asking patients to keep their existing product until their replacement product can be secure. Patients may receive either EpiPen Auto-Injector or the authorized generic for EpiPen Auto-Injector at the pharmacy as a replacement based on availability. It is important that patients continue to carry their current EpiPen Auto-Injector until they receive a replacement device.