Charles Vernon Reed, age 41 of Rome, Charged with Driving with Suspended or Revoked License
Sarah Brooke Jones, age 28 of Trion, Charged with Probation Violation
Novartis Consumer Health, Inc. (NCH) announced today that it is voluntarily recalling all lots of select bottle packaging configurations 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.
The affected bottle sizes are attached to this release. The Novartis Consumer Health Inc. Lincoln, NE facility has voluntarily suspended operations and shipments to accelerate maintenance and other improvement activities at the site.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA).
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.
These over-the-counter products were distributed nationwide to wholesalers and retailers.
Novartis Consumer Health Inc. is notifying its distributors and customers and is arranging for return of all recalled products. Wholesalers and retailers should stop distribution and return the affected product using Novartis Product Return information that is being provided to them.
Consumers that have the product(s) being recalled should stop using the product(s) and contact the Novartis Consumer Relationship Center at 1-888-477-2403 (available Monday-Friday 9 a.m. to 8 p.m. Eastern Time) for information on how to return the affected products and receive a full refund. For more detailed information, consumers should visit our website at www.novartisOTC.com2 as of January 9, 2012. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these drug products.
Adverse events that may be related to the use of these products may be reported to FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax:
- Online: www.fda.gov/medwatch/report.htm3
- Regular Mail: use postage-paid FDA form 3500 available at:
www.fda.gov/MedWatch/getforms.htm4.
Mail to MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787 - Fax: 1-800-FDA-0178
These actions announced today, highlight the strong Novartis commitment to a single quality standard for the Novartis Group. The Novartis Group is making the necessary investments and committing the right resources to ensure these are implemented across the entire Novartis Group network. The high quality of Novartis products and operations has been critical to building the Novartis Group reputation over the past 15 years. Novartis Group is committed to ensuring the highest standard for patients who rely on our products and medicines.
Novartis Consumer Health Inc. 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
The Novartis Group is fully committed to ensuring 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 companies stand behind the safety and efficacy of their products, and are 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.
Disclaimer
The foregoing release contains forward-looking statements that can be identified by terminology such as “potential,” “will,” “committed,” “commitment,” “plans,” or similar expressions, or by express or implied discussions regarding the potential length of the shutdown of our Lincoln, NE production facility, regarding the potential for any further regulatory actions at the Lincoln, NE production facility, regarding the potential for any further quality issues arising at any additional Novartis manufacturing facilities, or regarding the potential financial impact of the Lincoln, NE facility shutdown. 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 to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that our Lincoln, NE production facility will reopen at any particular time. Nor can there be any guarantee that actions described in this release will be the only regulatory actions required at the Lincoln, NE facility. Neither can there be any guarantee that further quality issues will not arise at any additional Novartis Group manufacturing facilities. Nor can there be any guarantee as to the potential financial impact on Novartis resulting from the shutdown of the Lincoln, NE production facility. In particular, management’s expectations could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally; unexpected manufacturing issues, including unexpected inabilities to satisfy regulators’ requirements for the reopening of the Lincoln, NE production facility; competition in general; government, industry and general public 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.com5.
Novartis is on Twitter. Sign up to follow @Novartis at http://twitter.com/novartis6.
The Partnership for Health and Accountability presented its prestigious Quality and Patient Safety Award to Redmond Regional Medical Center for its program that reduced Cardiovascular Disease Risk Factors at local Industries partnered with Redmond’s Occupational Health Team. This was the 6th consecutive year that Redmond has won a Patient Safety Award at the Georgia Hospital Association`s Partnership for Health and Accountability Annual Patient Safety Summit.
The 2011 project, entitled `Reducing Communities Risk of Cardiovascular Disease through Effective Worksite Risk Reduction Programs` won 2nd place in the Hospitals Category with 100- 299 beds. The project included over 5,000 employees in three worksites screened for risk of cardiovascular disease. The program identified volunteers through a screening program to participate in an eight week Risk Reduction Program taught by a registered dietician and nurse practitioner intervention. Results including 98% of participants lowering their cholesterol by an average of 43 points. Similar statistics included reductions in Low Density Lipoproteins, Triglycerides, Blood Pressure and Weight.
`It is an honor to see our Occupational Health team win such a prestigious award for the great work they do every day in with our industry partners in the communities we serve.” John Quinlivan, FACHE, CEO Redmond Regional Medical Center.
- Redmond Regional Medical Center was also presented with the Circle of Excellence Award for the fourth consecutive year. This honor is awarded to hospitals and health systems that have demonstrated a sustained commitment to quality and patient safety as evidenced by winning three or more PHA Patient Safety Awards within the previous five years. Redmond`s past awards from the Partnership for Healthcare and Accountability include:
- 2010: A Comprehensive Approach in a Multi-Hospital System to Improve Influenza Vaccination Rates Among Healthcare Personnel
- 2009: Reducing Patients and Employees Environmental and Infection Control Risks through Effective Rounding
- 2008: Preventing Ventilator Associated Pneumonia in the Intensive Care Unit
- 2007: Decreasing Door-To-Balloon Time for Patients Receiving PCI (percutaneous coronary intervention) for ST-Elevation Myocardial Infarction
- 2007: Reducing Healthcare Associated Infections: Methicillin Resistant Staph Aureus
- 2006: Reducing the Incidence of Contrast Induced Nephropathy (CIN)
Redmond Regional Medical Center is a 230 bed facility, serving as a referral source for all of northwest Georgia and parts of Alabama. Including its healthcare partners, Redmond has over 245 physicians with more than 30 specialties and a support staff of approximately 1,300 associates.
Little River Canyon National Preserve
The Return of Black Bears
Editor’s Note: Visitation to the Jacksonville State University Little River Canyon Center has been on the rise ever since it was opened to the public in 2009 but our newest visitors have created a little bit of a stir. Black Bear sightings are slowly on the rise and this press release from our National Park Service partners describes the welcomed phenomenon.
Black Bears are returning to the Lookout Mountain area. Many people are asking the staff at Little River Canyon National Preserve about black bears due to the high number of sightings, signs and footprints. The park has not had any problems with bear encounters. Bears in the park are quite reclusive and not used to human food or contact. All park sightings have ended with the bear leaving when it realizes a person is near.
A black bear is the only bear found east of the Mississippi River and it is normally not a threat to humans. Bears can become habituated to human food and human contact, increasing the likelihood of bear–human interactions that end badly, usually for the bear. To prevent this, the National Park Service is using animal resistant garbage cans at all picnic areas. Park Ranger Larry Beane said, “This has not only prevented bears from becoming attracted to people’s food in the park, it has prevented other animals from scattering garbage and becoming a nuisance. The cans have saved thousands of hours of work cleaning up after raccoons and opossums.” Keeping bears away from human food is one of the best ways to keep both the bears and our visitors safe.
As black bears become more common here it is very important that we keep them wild. Confrontations with black bears are very rare. Most incidents are the direct result of people approaching the bear for photographs, surprising the bear, or feeding the bear. You can minimize the possibility of a confrontation by following these basic rules: Never approach, feed or follow wild animals, especially bears. Black bears are scavengers looking for an easy meal like human food, pet food, and even bird seed. If they are attracted to your yard or garden more than a few times, find out what is attracting them and remove it.
The bear that was hit by a car on 19 December was a healthy male. Tracy Nelson with Alabama Department of Conservation and Natural Resources said it was a nice size bear for the south. Mr. Nelson said “This bear was probably in its home range and may have been raised as a cub in its home territory.” Bear sightings have increased in both number and range leading officials to suspect several bears may be using the park and surrounding area as their home territory. A male’s range may be as large as eight miles across overlapping several female ranges. A female’s range is five to six miles across. In years when food is hard to find black bears travel farther looking for food.
Bears were once common here. From the early 1900s to 1980s, generations of people lived here with very limited bear interaction. A bear moved through in the late 1970s but was killed in Jackson County. A few bear sightings were reported in the 1980s. Some of the recent bears moved into the area with ear tags from Georgia. At least two with Georgia tags have been recorded. As these bears find good habitat and breed, their numbers will likely grow to what the habitat can support.
Black bears attract large numbers of tourists to the Great Smokey Mountains, increasing the tourism of the area. Tourism is one of the main industries providing incomes in both Cherokee and DeKalb County. The bears have returned and though not numerous, the park protects them and their habitat.
For more information, call the park office at (256) 845-9605.
The Veterans Memorial Park Committee is selling markers to be installed at the Veterans Memorial Park located at Dowdy Park in Summerville. The cost of the 12" x 12 " markers is $225. There are 32 left in the current phase of construction of the park. Applications are available at United Community Bank in Summerville or call Willie Joe McGraw at 706-506-0558.
