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
|
Mylan is committed to replacing recalled devices at no cost and
Mylan would like to reassure patients that there will be no
additional replacement-related financial burden to them as a result
of this recall. Patients, customers and distributors are being
notified and should refer to Mylan.com/EpiPenRecall for updates on
product return and replacement instructions. We are asking patients
to keep their existing product until their replacement product can
be secured.
Patients may receive either EpiPen Auto-Injector or the
authorized generic for EpiPen Auto-Injector at the pharmacy as a
replacement based on availability. The authorized generic has the
exact same drug formulation, has the exact same operating
instructions and is therapeutically equivalent to EpiPen Auto
Injector, and may be substituted for EpiPen Auto Injector.
It is important that patients continue to carry their current
EpiPen Auto-Injector until they receive a replacement
device.
To return your product please contact Stericycle at
877-650-3494. If you have any additional questions regarding this
recall, please contact Mylan Customer Relations at 800-796-9526 or
customer.service@mylan.com.
Adverse reactions or quality problems experienced with the use
of this product may be reported to the FDA's MedWatch Adverse Event
Reporting program either online, by regular mail or by fax.
- Complete and submit the report
Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download
form www.fda.gov/MedWatch/getforms.htm or call
1-800-332-1088 to request a reporting form, then complete and
return to the address on the pre-addressed form, or submit by fax
to 1-800-FDA-0178.
This voluntary recall is being conducted with the knowledge of
FDA.
Epinephrine is the first-line treatment for a life-threatening
allergic reaction (anaphylaxis) and access to this product is
critical in the event of an emergency. Delays in epinephrine
administration have been associated with negative health
consequences.
More information about the risks and benefits of EpiPen®
Auto-Injector can be found at EpiPen.com.
Please see the full Prescribing Information and Patient
Information.
Forward-Looking Statements
This press
release includes statements that constitute "forward-looking
statements." These statements are made pursuant to the safe
harbor provisions of the Private Securities Litigation Reform Act
of 1995 and include statements, among others, that select lots of
EpiPen and EpiPen Jr Auto-Injectors will be recalled; that the
recall will extend to locations outside the U.S., including
additional markets in Europe,
Asia, and North and South America; that Mylan is committed to
replacing recalled devices at no cost and that patients will
experience no additional replacement-related financial burden to
them as a result of this recall. Because forward-looking
statements inherently involve risks and uncertainties, actual
future results may differ materially from those expressed or
implied by such statements. Factors that could cause or
contribute to such differences include, but are not limited to: the
effect of any additional recalls of EpiPen and EpiPen Jr®
Auto-Injectors; any changes in or difficulties with Mylan's or its
partners' ability to develop, manufacture, and commercialize EpiPen
and EpiPen Jr® Auto-Injectors or the authorized generic for EpiPen
Auto-Injector; the effect of any changes in Mylan's or its
partners' customer and supplier relationships and customer
purchasing patterns; other changes in third-party relationships;
the impact of competition; changes in the economic and financial
conditions of the businesses of Mylan or its partners; the scope,
timing, and outcome of any ongoing legal proceedings and the impact
of any such proceedings on Mylan's or its partners' business; any
regulatory, legal, or other impediments to Mylan's or its partners'
ability to bring products to market; actions and decisions of
healthcare and pharmaceutical regulators, and changes in healthcare
and pharmaceutical laws and regulations, in the United
States and abroad; Mylan's and its partners' ability to
protect intellectual property and preserve intellectual property
rights; risks associated with international operations; other
uncertainties and matters beyond the control of management; and the
other risks detailed in Mylan's filings with the Securities and
Exchange Commission. Mylan undertakes no obligation to update these
statements for revisions or changes after the date of this
release.
Mylan is a global pharmaceutical company committed to setting
new standards in healthcare. Working together around the world to
provide 7 billion people access to high quality medicine, we
innovate to satisfy unmet needs; make reliability and service
excellence a habit; do what's right, not what's easy; and impact
the future through passionate global leadership. We market a
growing portfolio of approximately 7,500 products around the world,
including antiretroviral therapies on which approximately 50% of
people being treated for HIV/AIDS in the developing world depend.
We market our products in more than 165 countries and territories.
We are one of the world's largest producers of active
pharmaceutical ingredients. Every member of our more than
35,000-strong workforce is dedicated to creating better health for
a better world, one person at a time. Learn more at
mylan.com.
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SOURCE Mylan N.V.