Mylan announced that Meridian Medical Technologies, a Pfizer company and Mylan's manufacturing partner for EpiPen® Auto-Injector, has expanded a voluntary recall of select lots of EpiPen (epinephrine injection, USP) and EpiPen Jr® (epinephrine injection, USP) Auto-Injectors to now include additional lots distributed in the U.S. and other markets in consultation with the U.S. Food and Drug Administration (FDA).
This recall is being conducted as a result of the receipt of two previously disclosed reports outside of the U.S. of failure to activate the device due to a potential defect in a supplier component. The potential defect could make the device difficult to activate in an emergency (failure to activate or increased force needed to activate) and have significant health consequences for a patient experiencing a life-threatening allergic reaction (anaphylaxis). Both reports are related to the single lot that was previously recalled. The incidence of the defect is extremely rare and testing and analysis across the potentially impacted lots has not identified any units with a defect. However, the recall is being expanded to include additional lots as a precautionary measure out of an abundance of caution.
The recalled product was manufactured by Meridian Medical Technologies, a Pfizer company, and distributed by Mylan Specialty between December 2015 and July 2016. The expanded voluntary recall is being initiated in the U.S. and also will extend to additional markets in Europe, Asia, North and South America.
The recall impacts the 0.3 mg and 0.15 mg strengths of EpiPen Auto-Injector. None of the recalled lots include the authorized generic for EpiPen Auto-Injector, which is also manufactured by Meridian Medical Technologies.
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 |
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