The voluntary recall is precautionary following consumer complaints of chipped and broken pills and inconsistent bottle packaging line clearance practices possibly resulting in mixed tablets
There have been no related adverse events reported with the issues leading to the recall
US Consumers are asked to either destroy or return unused product identified in the recall to Novartis Consumer Health Inc.
To accelerate improvements at its Lincoln, Nebraska facility, Novartis Consumer Health has temporarily suspended operations as well as shipments from the site
A one-time charge currently estimated at USD 120 million related to the recall and improvement efforts will be taken in the fourth quarter of 2011 by Novartis Consumer Health Inc.
Novartis is fully committed to maintaining high quality standards of its products
Basel, January 8, 2012- Novartis Consumer Health Inc. (NCH) informed customers, that it is voluntarily recalling all lots of select bottle packaging configurations from retailers of Excedrin® and NoDoz® products with expiry dates of December 20, 2014 or earlier as well as Bufferin® and Gas-X Prevention® products with expiry dates of December 20, 2013 or earlier, in the United States. NCH is taking this action as a precautionary measure, because the products may contain stray tablets, capsules, or caplets from other Novartis products, or contain broken or chipped tablets.
Information on the affected bottle sizes, and related expiry dates will be available at as of January 9, 2012. This precautionary recall follows the recent voluntary suspension of operations and shipments from Novartis Consumer Health Inc's Lincoln, NE facility. These actions were taken to accelerate maintenance and other improvement activities at the site.
There have been no related adverse event reports received as a result of these issues. The established safety profile for each of these products remains consistent. Mixing of different products in the same bottle could result in consumers taking the incorrect product and receiving a higher or lower strength than intended or receiving an unintended ingredient. This could potentially result in overdose, interaction with other medications a consumer may be taking, or an allergic reaction if the consumer is allergic to the unintended ingredient. NCH is not aware of adverse events reported with the issues leading to the recall. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA) and Novartis Consumer Health will continue to work closely with the agency as well as its customers throughout this process.
"We are committed to a single quality standard for the entire Novartis Group and we are making the necessary investments and committing the right resources to ensure these are implemented across our entire network," said Joseph Jimenez, CEO of Novartis. "The high quality of our products and operations has been critical to building the Novartis reputation over the past 15 years. We are committed to ensuring the highest standard for patients who rely on our products and medicines."
NCH is recalling these products as a precaution due to an internal product review and complaints that identified issues such as broken gelcaps, chipped tablets and inconsistent bottle packaging line clearance practices, where a potential for a tablet mix up could not be ruled out.
NCH plans to gradually resume operations at its Lincoln, NE site following implementation of planned improvements and in agreement with the FDA. The Novartis Consumer Health Inc. Lincoln, NE facility produces a variety of products mainly for the US market with annual sales value of less than 2% of Novartis Group sales. At this stage, it is not possible to determine when the plant will resume full operations and the full financial impact of these events. NCH will take a one-time charge currently estimated at USD 120 million in the fourth quarter of 2011, relating to the recalls and improvement work at the Lincoln, NE facility.
Novartis commitment to quality
Novartis Group is fully committed to ensure the quality,
safety and integrity of its products. All Novartis Group
companies have a clear commitment to patients and Health
Authorities to ensure high quality standards for all our
products and services. Novartis Group stands behind the
safety and efficacy of its products, and is fully committed
to maintaining high quality standards at all production
sites in the US and around the world. All Novartis Group
products are subjected to strict manufacturing, testing and
monitoring standards. Where they fall outside the
standards, Novartis Group companies take actions to correct
the issue and may recall products as a precaution.
Note to US consumers and customers
Consumers and customers in the US who have questions can
call the Consumer Relationship Center at 1-888-477-2403
(available Monday-Friday 9 a.m. to 8 p.m. Eastern Time).
For more detailed information regarding the product, potential drug reactions, impacted configurations, related NDC numbers and expiry dates, please visit our website starting January 9, 2012 at .
Disclaimer
The foregoing release contains forward-looking statements
that can be identified by terminology such as
"committed", plans", "will" or
similar expressions, or by express or implied discussions
regarding potential new indications or labeling for
Excedrin, Bufferin, Gas-X Prevention and NoDoz or regarding
potential future revenues from Excedrin, Bufferin, Gas-X
Prevention and NoDoz. You should not place undue reliance
on these statements. Such forward-looking statements
reflect the current views of management regarding future
events, and involve known and unknown risks, uncertainties
and other factors that may cause actual results with
Excedrin, Bufferin, Gas-X Prevention and NoDoz to be
materially different from any future results, performance
or achievements expressed or implied by such statements.
There can be no guarantee that Excedrin, Bufferin, Gas-X
Prevention and NoDoz will be approved for any additional
indications or labeling in any market. Nor can there be any
guarantee that Excedrin, Bufferin, Gas-X Prevention and
NoDoz will achieve any particular levels of revenue in the
future. In particular, management's expectations
regarding Excedrin, Bufferin, Gas-X Prevention and NoDoz
could be affected by, among other things, unexpected
regulatory actions or delays or government regulation
generally; unexpected clinical trial results, including
unexpected new clinical data and unexpected additional
analysis of existing clinical data; the ability to obtain
or maintain patent or other proprietary intellectual
property protection; competition in general; government,
industry and general publi pricing pressures; the impact
that the foregoing factors could have on the values
attributed to the Novartis Group's assets and
liabilities as recorded in the Group's consolidated
balance sheet, and other risks and factors referred to in
Novartis AG's current Form 20-F on file with the US
Securities and Exchange Commission. Should one or more of
these risks or uncertainties materialize, or should
underlying assumptions prove incorrect, actual results may
vary materially from those anticipated, believed, estimated
or expected. 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 Group provides innovative healthcare solutions
that address the evolving needs of patients and societies.
Headquartered in Basel, Switzerland, Novartis offers a
diversified portfolio to best meet these needs: innovative
medicines, eye care, cost-saving generic pharmaceuticals,
preventive vaccines and diagnostic tools, over-the-counter
and animal health products. Novartis is the only global
company with leading positions in these areas. In 2010, the
Group's continuing operations achieved net sales of USD
50.6 billion, while approximately USD 9.1 billion (USD 8.1
billion excluding impairment and amortization charges) was
invested in R&D throughout the Group. Novartis Group
companies employ approximately 121,000 full-time-equivalent
associates and operate in more than 140 countries around
the world. For more information, please visit
http://www.novartis.com.
Novartis is on Twitter. Sign up to follow @Novartis at .
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