Mylan Provides Update on Meridian
Medical Technologies', a Pfizer Company, Expanded Voluntary Worldwide
Recall of EpiPen® Auto-Injector
HERTFORDSHIRE, England and
PITTSBURGH,
March 31, 2017 /
PRNewswire/
-- Mylan N.V.
(NASDAQ, TASE: MYL) today 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
|
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
|
