MORGANTOWN, W.Va., Oct. 25, 2019 /PRNewswire/ -- Mylan
Pharmaceuticals Inc. is conducting a voluntary nationwide recall of
one lot (see table below) of Alprazolam Tablets, USP C-IV 0.5 mg,
to the consumer/user level. This lot is being recalled due to the
potential presence of foreign substance. Clinical impact from the
foreign material, if present, is expected to be rare, but the
remote risk of infection to a patient cannot be ruled out. To date,
Mylan has not received any adverse events related to this
batch.
Alprazolam Tablets are indicated for the management of anxiety
disorder, the short-term relief of symptoms of anxiety, and the
treatment of panic disorder, with or without agoraphobia.
Alprazolam Tablets, USP C-IV 0.5 mg, are packaged in bottles of
500. This batch was distributed in the U.S. between July 2019 and August
2019. The recalled lot is as follows:
NDC
|
Product Description
and Strength
|
Size
|
Lot number
|
Expiry
|
0378-4003-05
|
Alprazolam Tablets,
USP C-IV 0.5 mg
|
Bottles of
500
|
8082708
|
September
2020
|
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 mylan5924@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 1-888-843-0255 for
the documentation packet to return the product.
- Consumer: Please contact Stericycle at 1-888-843-0255
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 approximately
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.