ROCKFORD, Ill., March 18,
2019 /PRNewswire/ -- Mylan Institutional LLC is
conducting a voluntary nationwide recall of two
lots (see table below) of Levoleucovorin Injection, 250 mg/25 mL
tothe consumer/user level. The lots were
manufactured by Alidac Pharmaceuticals Limited and
distributed by Mylan Institutional LLC. The
Levoleucovorin Injection is being recalled
due to the presence of particulate matter identified
as copper salts. The particulate matter was discovered during
12-month stability testing.
Administration of a sterile injectable that has foreign
particulates has the potential of severe health consequences.
Intravenous administration of a solution containing particulates
could lead to local irritation, vasculitis/phlebitis, antigenic or
allergic reactions, and microvascular obstruction, including
pulmonary embolism. To date, Mylan has not received any reports of
adverse events related to this recall.
Levoleucovorin injection is indicated for rescue after high-dose
Methotrexate therapy in osteosarcoma; for diminishing the toxicity
and counteracting the effects of impaired Methotrexate elimination
and of inadvertent overdose of folic acid antagonists; and for the
use in combination chemotherapy with 5-fluorouracil in the
palliative treatment of patients with advanced metastatic
colorectal cancer.
Levoleucovorin Injection, 250 mg contains 25 mL sterile solution
in a single-use vial. Each vial is packaged in a carton
containing one single-use vial. The batches were distributed
in the U.S. between August 2017
and July 2018. The recalled lots are
as follows:
NDC
|
Product Description and Strength
|
Size
|
Lot number
|
Expiry
|
67457-601-30
|
Levoleucovorin Injection 250 mg/25 mL
|
25 mL vial
|
APB032
|
April 2019
|
67457-601-30
|
Levoleucovorin Injection 250 mg/25 mL
|
25 mL vial
|
APB033
|
April 2019
|
Mylan has notified its distributors and customers
by letter and is arranging for return of
all recalled products. Following are actions for
wholesalers, retailers and consumers:
- Wholesaler: Immediately examine your inventory,
quarantine and discontinue distribution of these lots. In addition,
if you have further distributed the product, please identify your
retail level customers and provide a list of customers via
Microsoft excel file to mylan7079@stericycle.com within 10 business
days. Stericycle will notify your retail level customers that
received the affected batches.
- Retailer: Immediately examine your inventory,
quarantine and discontinue distribution of these lots.
Additionally, if you have further distributed the product, please
identify the consumer and notify them immediately of this product
recall. The consumer should be instructed to contact Stericycle at
1-866-551-2706 for the documentation packet to return the
product.
- Consumer: Please contact Stericycle at
1-866-551-2706 for the documentation packet to return product to
Stericycle.
Consumers with questions regarding this recall can
contact Mylan Customer Relations at 800.796.9526 or
customer.service@mylan.com, Monday through
Friday from 8 a.m. – 5 p.m. EST.
Consumers should contact their physician
or healthcare provider if they have experienced any
problems that may be related to using this
drug product.
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 recall is being conducted with the knowledge
of the U.S. Food and Drug Administration.
About Mylan
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 offer
a growing portfolio of
more than 7,500 marketed products around the
world, including antiretroviral therapies on which more
than 40% of people being treated for HIV/AIDS
globally 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
approximately 35,000-strong workforce
is dedicated to creating better
health for a better world, one person
at a time. Learn more at
Mylan.com. We routinely post
information that may be important to investors
on our website at investor.mylan.com.
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SOURCE Mylan N.V.