PRINCETON, N.J., Nov. 8, 2018 /PRNewswire/ -- Sandoz Inc. is
voluntarily recalling one lot of Losartan Potassium
Hydrochlorothiazide Tablets, USP 100mg/25mg to the consumer level.
This product is being recalled due to the trace amount of an
impurity, N-nitrosodiethylamine (NDEA) contained in the API
Losartan, USP manufactured by Zhejiang Huahai Pharmaceutical Co.
Ltd. Sandoz Inc. Losartan Potassium Hydrochlorothiazide product is
manufactured by Lek Pharmaceuticals dd, Ljubljana, Slovenia. This impurity, which is a
substance that occurs naturally in certain foods, drinking water,
air pollution, and industrial processes, has been classified as a
probable human carcinogen as per International Agency for Research
on Cancer (IARC).
To date, Sandoz Inc. has not received any reports of adverse
events related to this lot.
Losartan Potassium Hydrochlorothiazide Tablets, USP are
indicated for the treatment of hypertension. It may be used alone
or in combination with other antihypertensive agents. The product
can be identified as Losartan Potassium Hydrochlorothiazide, 100
mg/25 mg tablets in 1000-count plastic bottles, NDC 0781-5207-10,
Lot number JB8912; Exp. Date 06/2020. This product was distributed
nationwide to distributors. The affected product was not
distributed prior to October 8,
2018.
Sandoz Inc. is notifying its distributors by letter via
overnight mail and patients by this public notification.
Distributors and retailers that have product which is being
recalled should immediately stop distribution of the identified lot
above and quarantine any quantities remaining in your control and
return the recalled product to the identified Reverse
Distributor.
Patients with questions regarding this recall can contact Sandoz
Inc. at 1-800-525-8747 Monday-Friday 8:30
AM – 5:00 PM (EST) or email
usdrugsafety.operations@novartis.com. Patients should contact
their pharmacist or physician who can advise them about an
alternative treatment prior to returning their medication. Patients
who are on Losartan Potassium Hydrochlorothiazide should continue
taking their medication, as the risk of harm to a patient's health
may be higher if the treatment is stopped immediately without any
alternative treatment. Patients should contact their physician or
healthcare provider if they have experienced any problems that may
be related to taking or using Losartan Potassium
Hydrochlorothiazide.
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 made with the knowledge of the Food and
Drug Administration.
Disclaimer
This press release contains forward-looking
statements within the meaning of the United States Private
Securities Litigation Reform Act of 1995. Forward-looking
statements can generally be identified by words such as
"potential," "can," "will," "plan," "expect," "anticipate," "look
forward," "believe," "committed," "investigational," "pipeline,"
"launch," or similar terms, or by express or implied discussions
regarding potential marketing approvals, new indications or
labeling for the investigational or approved products described in
this press release, or regarding potential future revenues from
such products. You should not place undue reliance on these
statements. Such forward-looking statements are based on our
current beliefs and expectations regarding future events, and are
subject to significant known and unknown risks and uncertainties.
Should one or more of these risks or uncertainties materialize, or
should underlying assumptions prove incorrect, actual results may
vary materially from those set forth in the forward-looking
statements. There can be no guarantee that the investigational or
approved products described in this press release will be submitted
or approved for sale or for any additional indications or labeling
in any market, or at any particular time. Nor can there be any
guarantee that such products will be commercially successful in the
future. In particular, our expectations regarding such products
could be affected by, among other things, the uncertainties
inherent in research and development, including clinical trial
results and additional analysis of existing clinical data;
regulatory actions or delays or government regulation generally;
global trends toward health care cost containment, including
government, payor and general public pricing and reimbursement
pressures; our ability to obtain or maintain proprietary
intellectual property protection; the particular prescribing
preferences of physicians and patients; general political and
economic conditions; safety, quality or manufacturing issues;
potential or actual data security and data privacy breaches, or
disruptions of our information technology systems, and other risks
and factors referred to in Novartis AG's current Form 20-F on file
with the US Securities and Exchange Commission. Novartis is
providing the information in this press release as of this date and
does not undertake any obligation to update any forward-looking
statements contained in this press release as a result of new
information, future events or otherwise.
About Sandoz
Sandoz is a global leader in generic
pharmaceuticals and biosimilars. As a division of the Novartis
Group, our purpose is to discover new ways to improve and extend
people's lives. We contribute to society's ability to support
growing healthcare needs by pioneering novel approaches to help
people around the world access high-quality medicine. Our portfolio
of approximately 1000 molecules, covering all major therapeutic
areas, accounted for 2017 sales of USD 10.1
billion. In 2017, our products reached more than 500 million
patients. Sandoz is headquartered in Holzkirchen, in Germany's Greater
Munich area.
Sandoz is on Twitter. Sign up to follow @Sandoz_global at
http://twitter.com/Sandoz_Global.
Follow our blog at www.sandoz.com/makingaccesshappen.
Patients with questions can contact Sandoz toll-free at
1-800-525-8747
Novartis Media Relations
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324 2200
Email: media.relations@novartis.com
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Althoff
Novartis Global Media
Relations
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(direct)
+41 79 593 4202
(mobile)
eric.althoff@novartis.com
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Chris
Lewis
Sandoz Global
Communications
+49 8024 476 1906
(direct)
chris.lewis@sandoz.com
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Leslie
Pott
Sandoz US
Communications
+1 609 627
5287
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Email: investor.relations@novartis.com
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content:http://www.prnewswire.com/news-releases/sandoz-inc-issues-voluntary-nationwide-recall-of-one-lot-of-losartan-potassium-and-hydrochlorothiazide-due-to-the-detection-of-trace-amounts-of-ndea-n-nitrosodiethylamine-impurity-found-in-the-active-pharmaceutical-ingredient--300747198.html
SOURCE Sandoz Inc.