Company Contact:
Novartis Pharmaceuticals Corporation
1-888-669-6682
EAST
HANOVER, N.J., Sept. 11,
2023 /PRNewswire/ -- Novartis is conducting a
voluntary nationwide recall at the consumer level of one lot of its
Sandimmune® Oral Solution (cyclosporine oral solution,
USP), 100 mg/mL in the US due to crystal formation observed in some
bottles, which could potentially result in incorrect dosing. No
other Sandimmune formulations are impacted.
Sandimmune® Oral Solution (cyclosporine oral
solution, USP), 100 mg/mL, packaged in 50 mL bottles, is indicated
for the prophylaxis of organ rejection in kidney, liver, and heart
allogeneic transplants. The drug may also be used in the treatment
of chronic rejection in patients previously treated with other
immunosuppressive agents1.
Risk Statement: Crystallization of cyclosporine in
Sandimmune Oral Solutionis likely to result in non-uniform
distribution of the cyclosporine in the product, resulting in
under-dosing or over-dosing. There is a reasonable probability that
under-dosing may result in lower exposures and decrease in efficacy
which could ultimately lead to graft rejection and graft loss in
transplant patients. Furthermore, over-dosage may manifest itself
as cyclosporine toxicity in the long term if over exposure
continues. Novartis has not received any reports of adverse events
related to this recall, to date.
The affected lot number and expiration date is: FX001691
(expiration date 12/2025). This lot was distributed nationwide to
wholesalers across the US, beginning in April 2023.
Novartis is notifying its distributors via a recall notification
letter and is arranging for return of the recalled lot from
distributors, retailers and consumers. Additionally, Novartis is
notifying health care providers who have prescribed this product to
contact their patients. Consumers that have bottles from the
recalled lot of Sandimmune Oral Solution (cyclosporine oral
solution, USP), 100mg/mL, should contact their health care
provider.
In the event that a patient experiences an adverse reaction or
quality problem involving this product, they should immediately
contact their health care provider and Novartis to report the event
or finding. Patients or health care providers may call the Novartis
customer interaction center
at 888-NOW-NOVA (888-669-6682) from 8:30 AM - 5:00 PM ET Monday through Friday, or
may report an adverse event through https://www.novartis.com/report
or usdrugsafety.operations@novartis.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 recall is being conducted with the knowledge of the U.S.
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," "may,"
"could," "would," "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 and requirements for increased pricing transparency; our
ability to obtain or maintain proprietary intellectual property
protection; the particular prescribing preferences of physicians
and patients; general political, economic and business conditions,
including the effects of and efforts to mitigate pandemic diseases
such as COVID-19; safety, quality, data integrity 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 Novartis
Novartis is reimagining medicine to improve and extend people's
lives. We deliver high-value medicines that alleviate society's
greatest disease burdens through technology leadership in R&D
and novel access approaches. In our quest to find new medicines, we
consistently rank among the world's top companies investing in
research and development. Novartis employs about 14,000 people in
the United States. For more
information, please visit https://www.novartis.us
Novartis and Novartis US is on Twitter. Sign up to follow
@Novartis at https://twitter.com/novartisnews
and @NovartisUS
at https://twitter.com/NovartisUS.
References
- Sandimmune [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals
Corporation; 2021.
# #
Novartis Media Relations
E-mail:
media.relations@novartis.com
|
North
America
Julie Masow
|
+1 862 579
8456
|
Michael Meo
|
+1 862 274
5414
|
Marlena
Abdinoor
|
+1 617 335
9525
|
Novartis Investor Relations
E-mail:
investor.relations@novartis.com
|
North
America
Sloan
Simpson
|
+1 862 778
5052
|
|
|
|
View original
content:https://www.prnewswire.com/news-releases/novartis-issues-voluntary-nationwide-recall-of-one-lot-of-sandimmune-oral-solution-cyclosporine-oral-solution-usp-100-mgml-due-to-crystallization-301923365.html
SOURCE Novartis Pharmaceuticals Corporation