Julia's Spices Inc Recalls Hulled Sesame Seeds Because of Possible Health Risk

Contact:
Julia's Spices 626-369-5525

FOR IMMEDIATE RELEASE - March 12, 2010 - JULIA'S SPICES INC, of City of Industry, Ca is recalling all HULLED SESAME SEEDS distributed between November 17, 2009 and February 25,2010, because they have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis. For more information on Salmonella please visit the Centers for Disease Control and Prevention's website at http://www.cdc.gov¹.

Julia's Spices Inc was notified of this contamination by our supplier. To date no illnesses have been reported to Julia's Spices Inc.

The affected Hulled Sesame Seed also known as White Sesame Seeds were distributed in plastic bags between November 17, 2009 and February 25, 2010 in California and Utah by Julia's Spices Inc's through retail stores. Only the following products are being recalled:

NAME	UPC	Package Size
Julia's Spices Ajonjoli / Sesame Seed	810338001330'	3.5 oz
Julia's Spices Ajonjoli / Sesame Seed	810338000043'	1 9/16 oz
Julia's Spices Ajonjoli / Sesame Seed	810338020027'	1 9/16 oz

Consumers who have purchased this item are urged to return them to their place of purchase. Consumers with any questions may contact Julia's Spices Inc, at 626-369-5525 between the hours of 1pm-4pm PST Monday through Wednesday. We thank you for your cooperation.

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Tastefully Simple Issues Voluntary Recall for Toasted Garlic & Parmesan Cheese Ball Mix

Contact:
Lynn Grueneich
Senior Lead, Communications
320.763.2100
lynn.grueneich@tastefullysimple.com

FOR IMMEDIATE RELEASE - March 12, 2010 - Alexandria, MN - Tastefully Simple is voluntarily recalling select 1.1-ounce retail packages and 0.3-ounce samples of Toasted Garlic & Parmesan Cheese Ball Mix. The company, along with others in the food industry, is joining in the efforts of a nationwide ingredient recall to protect consumers from potential Salmonella exposure.

The company was notified about this potential issue by one of its ingredient suppliers. Salmonella is an organism which can cause serious and sometimes fatal infections in young children, the elderly, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea, nausea, vomiting and abdominal pain.

No illnesses regarding this product have been reported to the company to date. However, Tastefully Simple has decided to initiate this voluntary recall because of its commitment to the safety and health of the public – and its commitment to offering only the highest quality products.

This recall applies only to a small number of retail packages of Toasted Garlic & Parmesan Cheese Ball Mix (Item: 723200) and sample packets (Item: 723270) shipped since February 12, 2010. The following lot codes, which can be found on the bottom of the retail boxes, are involved in the recall: 9315, 9317 and 0004. The lot codes for the sample packets affected are: 9313, 9314 and 0005, which are embossed on the left front side of the packet.

Tastefully Simple encourages anyone who has purchased or received a package of Toasted Garlic & Parmesan Cheese Ball Mix with the lot codes above to destroy it, and call 1.800.235.4513 between 8:00 am and 6:00 pm CST Monday through Friday to receive an alternate product. If you have any questions and concerns or would like additional information, simply visit tastefullysimple.com or fda.gov.

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Emmi - Roth Käse USA Announces Recall of Spreadables brand Crab Creole and Shrimp Scampi Cheese Spreads

Contact:
Jim Natzke
608-328-2122 x5
Kevin Davis
608-328-2122 x59

FOR IMMEDIATE RELEASE - March 12th, 2010 - Monroe, Wis - Emmi - Roth Käse USA is voluntarily recalling approximately 1,971 total individual containers of 7 ounce and 2 pound Spreadables brand Crab Creole and Shrimp Scampi cheese spreads because they have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.

"Spreadables" brand Crab Creole and Shrimp Scampi cheese spreads were sold nationwide by Emmi-Roth Käse USA sales people and distributors. They were sold from 12/11/09 thru 3/8/10. The recall lots (same as sell by date) are as follows:

Crab Creole 7 oz. tub: 5/9/10, 5/2/10, 4/25/10, 5/23/10, 3/21/10, 3/14/10, 5/26/10
Crab Creole 2 lb. tub: 5/9/10, 5/2/10, 4/25/10, 3/29/10, 5/16/10, 3/21/10, 3/14/10
Shrimp Scampi 7 oz. tub: 5/23/10, 5/16/10, 3/29/10
Shrimp Scampi 2 lb. tub: 5/16/10, 5/23/10, 4/11/10

All known purchasers of the 1,971 containers of Spreadables brand Crab Creole and Shrimp Scampi cheese spreads have been contacted and told to destroy the product. A full refund has been offered to every customer.

Spreadables brand Crab Creole and Shrimp Scampi cheese spreads were sold in clear 7 ounce and 2 pound containers. The top of the container is labeled as the original "Spreadables" gourmet cheese spread in "Crab Creole" and "Shrimp Scampi" flavor varieties. The bottom of the containers feature the nutritional information, as well as: "Roth Käse USA Ltd."

To date, no known illnesses have been associated with this product.

Spreadables brand Crab Creole and Shrimp Scampi cheese spreads were made using Hydrolyzed Vegetable Protein (HVP), manufactured by Basic Food Flavors, Inc., Las Vegas, Nevada. One lot of HVP had tested positive for Salmonella Tennesse and was reported to the FDA, in addition to being found in the facility of Basic Food Flavors, Inc.

These products should be destroyed immediately. Consumers with questions should contact Jim Natzke, Vice President of Operations, Emmi-Roth Käse USA at 608.328.2122 x5 or Kevin Davis x59 QC Manager (Monday – Friday 8:00am-5:00pm C.S.T.) for replacement, substitution or refund.

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National Native HIV and AIDS Awareness Day

For the fourth year in a row, on March 20, many communities around our country will stop to observe National Native HIV/AIDS Awareness Day (NNHAAD). The National Native HIVAIDS Awareness Day Planning Committee comprised of representatives from Colorado State University's Commitment to Action for 7th-Generation Awareness & Education: HIV/AIDS Prevention Project Exit Disclaimer, the Inter Tribal Council of Arizona  Exit Disclaimer, and National Native American AIDS Prevention Center Exit Disclaimer  works year round to support local observance of this day and to call attention to the impact of the epidemic among Native American/Alaskan Native and Native Hawaiian people in our nation.

The Indian Health Service (IHS), an agency within the Department of Health and Human Services, is responsible for providing federal health services to American Indians and Alaska Natives. We asked Captain Scott Giberson of the Indian Health Service about the importance of National Native HIV/AIDS Awareness Day. Capt. Giberson told us that American Indians/Alaskan Natives have "the third highest rate of new infections of HIV/AIDS of any race or ethnicity in the U.S. population." Check out the IHS website for more resources on responding to HIV/AIDS in American Indian/Alaskan Native communities, and make time on March 20th to respond to the HIV/AIDS epidemic in your communities.

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State and Local Edition

Inside This Issue – News

Minnesota DHS Reduces Mental Health Funding, Plans Mental Health System Reform
As part of Governor Tim Pawlenty's (R) latest budget recommendations, the Minnesota Department of Human Services (DHS) plans to reduce mental health spending by $17 million while broadening access to care. DHS plans to close mental health facilities in Cold Spring, Mankato, and Eveleth and cut 200 full-time positions by June 30, 2011. However, DHS also plans to redesign its service delivery system, creating new psychiatric care centers to provide assessments and 1-day crisis care. The state says the new facilities will provide faster assessment and placement than the current system and plans to create additional step-down facilities for subsequent treatment. In addition, DHS' new system will shift the responsibility for transporting mentally ill patients away from law enforcement.

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Montana Governor Seeks Federal Permission To Import Prescription Drugs From Canada
On March 11, Governor Brian Schweitzer (D) announced plans to seek Federal permission to import prescription drugs from Canada for use in state insurance programs. Governor Schweitzer estimates that importing the drugs could reduce the state's $100 million annual prescription drug costs for Medicaid, Children's Health Insurance Program, state employees, and inmates by $40 million. The governor is asking Health and Human Services Secretary Kathleen Sebelius to certify the Canadian drugs as safe and waive Medicaid provisions requiring that states spend such funds within the United States. Centers for Medicare & Medicaid officials said they had not yet seen Montana's proposal and could not comment.

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North Carolina DHHS Implements Medicaid Preferred Drug List, Estimates $90 Million Annual Savings
Effective March 15, the North Carolina Department of Health and Human Services (DHHS) instituted a preferred-drug list for the state's Medicaid program, estimated to save the state $90 million annually. Initially, the preferred list will include all drugs currently covered under Medicaid; however, DHHS will remove some drugs over time in consultation with the North Carolina Physician's Advisory Group. In addition, the state plans to consult mental health experts before removing any mental health medications from the preferred list. Nonpreferred drugs will remain available with prior authorization and for children requiring certain medication under the Early Periodic Screening, Diagnosis, and Treatment Program.

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Statement from the Department of Health and Human Services Regarding the Decisions of the U.S. Court of Federal Claims in the Omnibus Autism Proceeding

As these latest cases illustrated, there's no doubt that autism and autism spectrum disorders place a heavy burden on many families.  We know that autism and related disorders are conditions that present many special challenges to all families touched by these disorders.  That is why the U.S. Department of Health and Human Services provides services to families with family members with autism spectrum disorder and continues to support research to better understand risk factors and causes of autism spectrum disorders and develop more effective methods of treatment.

The medical and scientific communities have carefully and thoroughly reviewed the evidence concerning the theories that vaccines can cause autism and have found no association between vaccines and autism.

Vaccines save lives.  The safety and efficacy of vaccines—and the public's confidence in them—is one of our highest priorities.  If parents have questions or concerns about childhood vaccines, they should talk with their child's health care provider.

More information about autism and autism spectrum disorders can be found at www.hhs.gov/autism.

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Note: All HHS press releases, fact sheets and other press materials are available at http://www.hhs.gov/news.

Last revised: March 12, 2010

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FDA Announces New Boxed Warning on Plavix

Alerts patients, health care professionals to potential for reduced effectiveness

The U.S. Food and Drug Administration today added a boxed warning to the anti-blood clotting drug Plavix (clopidogrel), alerting patients and health care professionals that the drug can be less effective in people who cannot metabolize the drug to convert it to its active form.

Plavix reduces the risk of heart attack, unstable angina, stroke, and cardiovascular death in patients with cardiovascular disease by making platelets less likely to form blood clots. Plavix does not have its anti-platelet effects until it is metabolized into its active form by the liver enzyme, CYP2C19.
People who have reduced functioning of their CYP2C19 liver enzyme cannot effectively convert Plavix to its active form. As a result, Plavix may be less effective in altering platelet activity in those people. These "poor metabolizers" may not receive the full benefit of Plavix treatment and may remain at risk for heart attack, stroke, and cardiovascular death.

"We want to highlight this warning to make sure health care professionals use the best information possible to treat their patients," said Mary Ross Southworth, Pharm.D., a clinical analyst in the Division of Cardiovascular and Renal Products in the FDA's Center for Drug Evaluation and Research.

In May 2009, the FDA added this warning to the drug's label. After reviewing more data, the agency felt it was important to highlight this risk in a boxed warning.
It is estimated that 2 percent to 14 percent of the U.S. population are poor metabolizers. The FDA recommends that health care professionalsconsider alternative dosing of Plavix for these patients, or consider using other anti-platelet medications. Tests are available to assess CYP2C19 genotype to determine if a patient is a poor metabolizer.

Patients should not stop taking Plavix unless told to do so by their health care professional. They should talk with their health care professional if they have any concerns about Plavix.

Plavix is made under a Bristol-Myers Squibb - Sanofi Pharmaceuticals partnership.
For information:
FDA Drug Safety Communication: Reduced effectiveness of Plavix (clopidogrel) in patients who are poor metabloizers of the drug
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm203888.htm

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Pandemic (H1N1) 2009 - update 91

Weekly update

12 March 2010 -- As of 7 March 2010, worldwide more than 213 countries and overseas territories or communities have reported laboratory confirmed cases of pandemic influenza H1N1 2009, including at least 16713 deaths.

WHO is actively monitoring the progress of the pandemic through frequent consultations with the WHO Regional Offices and member states and through monitoring of multiple sources of information.

Situation update:

The most active areas of pandemic influenza transmission are currently in Southeast Asia, however, lower levels of pandemic virus circulation persist in other parts of Asia and in Eastern and South-eastern Europe. In West Africa, limited data suggests that pandemic influenza virus transmission may be increasing in region. Of note, seasonal influenza B viruses have been increasingly detected in Asia and appear to be spreading westward.

In Sub-Saharan Africa, limited data suggests that on-going community transmission of pandemic influenza virus continues to increase in parts of West Africa, without clear evidence of a peak in activity. Increased detections of pandemic influenza virus have been observed among sentinel surveillance sites in several countries, including Senegal and Cote D'Ivoire, however, to date, data is limited regarding the spectrum of clinical severity of cases. Recent increases in influenza activity have also been reported in Rwanda. Much of eastern and southern Africa likely experienced an earlier peak in pandemic influenza activity during November 2009 and late summer 2009, respectively.

In South and Southeast Asia, pandemic influenza virus circulation persist in most countries, however, overall transmission remains most active in Thailand, especially since mid January 2010. Approximately half of all provinces in Thailand reported that greater than 10% of all outpatients sought care for ILI, and approximately 25% of all patients with ILI at sentinel sites tested positive for influenza. The current increase in the number of cases in Thailand remains well below an earlier period of peak transmission during June through September 2009. In Bangladesh, an increasing trend in respiratory disease was reported, however, overall influenza activity remains low. In India, influenza virus transmission persist at lower levels in the western region of India, while activity in other regions has largely subsided.

In East Asia, pandemic influenza activity continues to decrease or remain low as levels of ILI return to seasonal baselines in Japan and in the Republic of Korea. In Mongolia, a recent sharp increase in ILI activity was associated predominantly with a resurgence of circulation of seasonal influenza B viruses. In China, pandemic influenza activity has declined since peaking during November 2009, however, overall influenza activity remains elevated, largely due to an increase in the circulation of seasonal influenza B viruses.

In North Africa and Western Asia, overall pandemic influenza activity remains low in most places, with the exception of Iraq and Afghanistan, both of which reported regional spread of influenza with an increasing trend in respiratory diseases activity. In Afghanistan, a moderate impact on the healthcare system was reported in association with increased respiratory diseases activity. Although overall influenza activity remains low in Iran, all recent influenza virus detection have been due to seasonal influenza B viruses.

In Europe, overall pandemic influenza transmission continued to decline as low levels of pandemic virus continue to circulate in parts of eastern and south-eastern Europe. The overall percentage of sentinel respiratory specimens testing positive for influenza remained low (6.8%) but slightly increased compared to the previous week. Pandemic H1N1 2009 virus continues to be the predominant circulating influenza virus in the European region with the exception of the Russian Federation and Sweden where influenza B was reported as co-dominant or dominant.

In the northern and the southern temperate zones of the Americas, overall pandemic influenza transmission remained low as influenza virus continued to circulate at low levels. In Central America, Nicaragua and Honduras, reported slight increases in respiratory diseases activity, possibly due to an increase in school outbreaks; however, it is unclear to what extent the increases are associated with circulation of pandemic influenza virus. In Brazil, an increasing trend of respiratory diseases with low overall intensity was reported in association with regional spread of influenza virus.

In the temperate zone of the southern hemisphere, overall influenza activity remained low, with sporadic detections of pandemic and seasonal influenza viruses.

Although pandemic influenza virus continues to be the predominant circulating influenza virus worldwide, circulation of seasonal influenza B viruses continue to increase and spread across Asia, parts of Eastern Europe, and Eastern Africa, but most notably in China, Mongolia, Iran and the Russian Federation.
The Global Influenza Surveillance Network (GISN) continues monitoring the global circulation of influenza viruses, including pandemic, seasonal and other influenza viruses infecting, or with the potential to infect, humans including seasonal influenza. For more information on virological surveillance and antiviral resistance please see the weekly virology update (Virological surveillance data, below).

Weekly update (Virological surveillance data)

(NEW) Weekly update on oseltamivir resistance to pandemic influenza A (H1N1) 2009 viruses [pdf 18kb] *Countries in temperate regions are defined as those north of the Tropic of Cancer or south of the Tropic of Capricorn, while countries in tropical regions are defined as those between these two latitudes.

**Abbreviations: influenza-like-illness (ILI), acute respiratory infection (ARI), and severe acute respiratory infection (SARI)
WHO Clinical Management Guidelines for Human infection with Pandemic (H1N1), 2009:

WHO Guidelines for Pharmacological Management of Pandemic (H1N1) 2009 Influenza and other Influenza Viruses:

(NEW) Map of influenza activity and virus subtypes (Week 8: 21 February -27 February 2010)

Map of influenza activity and virus subtypes [png 267kb]

Description: Displayed data reflect the most recent data reported to Flunet (www.who.int/FluNet), WHO regional offices or on Ministry of health websites in the last 2 weeks. The percent of specimens tested positive for influenza includes all specimens tested positive for seasonal or pandemic influenza. The pie charts show the distribution of virus subtypes among all specimens that were tested positive for influenza. The available country data were joined in larger geographical areas with similar influenza transmission patterns to be able to give an overview (http://www.who.int/csr/disease/swineflu/transmission_zones/en)

Qualitative indicators (Week 29 to Week 8: 13 July 2009 - 27 February 2010)

The qualitative indicators monitor: the global geographic spread of influenza, trends in acute respiratory diseases, the intensity of respiratory disease activity, and the impact of the pandemic on health-care services.
Human infection with pandemic (H1N1) 2009 virus: updated interim WHO guidance on global surveillance

The maps below display information on the qualitative indicators reported. Information is available for approximately 60 countries each week. Implementation of this monitoring system is ongoing and completeness of reporting is expected to increase over time.
List of definitions of qualitative indicators

Geographic spread of influenza activity

Map timeline

Trend of respiratory diseases activity compared to the previous week

Map timeline

Intensity of acute respiratory diseases in the population

Map timeline

Impact on health care services

Map timeline

Laboratory-confirmed cases of pandemic (H1N1) 2009 as officially reported to WHO by States Parties to the IHR (2005) as of 7 March 2010

Map of affected countries and deaths The countries and overseas territories/communities that have newly reported their first pandemic (H1N1) 2009 confirmed cases since the last web update (No. 90): None.

The countries and overseas territories/communities that have newly reported their first deaths among pandemic (H1N1) 2009 confirmed cases since the last web update (No. 90): None.

Region	Deaths*
WHO Regional Office for Africa (AFRO)	167
WHO Regional Office for the Americas (AMRO)	At least 7576
WHO Regional Office for the Eastern Mediterranean (EMRO)	1019
WHO Regional Office for Europe (EURO)	At least 4571
WHO Regional Office for South-East Asia (SEARO)	1664
WHO Regional Office for the Western Pacific (WPRO)	1716
Total*	At least 16713

* The reported number of fatal cases is an under representation of the actual numbers as many deaths are never tested or recognized as influenza related.

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Review of Oxaliplatin Billing at University of Arkansas for Medical Sciences Medical Center for Calendar Year 2005

Executive Summary

For calendar year 2005, University of Arkansas for Medical Sciences Medical Center billed for 10 times the number of units of oxaliplatin that was actually administered and received overpayments totaling $225,000 for the 11 outpatient claims that we reviewed.

Complete Report

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Review of California’s Department of Health Care Services Fiscal Year 2007 Payment Error Rate Measurement Universes

Review of California's Department of Health Care Services Fiscal Year 2007 Payment Error Rate Measurement Universes

Executive Summary

California's Department of Health Care Services (DHCS) was unable to reconcile the fiscal year (FY) 2007 Payment Error Rate Measurement (PERM) universes to the quarterly Forms CMS-64 and CMS-21. CMS developed the PERM program to comply with Federal requirements for measuring improper payments made in the fee-for-service (FFS), managed care, and eligibility components of Medicaid and SCHIP in FY 2007 and future years. The Office of Management and Budget requires CMS to include the PERM results in its annual accountability report.

We could not determine whether DHCS's managed care and FFS universes were complete and accurate. We were unable to reconcile the managed care and FFS universes to the Forms �CMS-64 and CMS-21.

CMS Regional Office officials stated that they had performed a reconciliation of the Forms CMS-64 and CMS-21 to the accounting records that DHCS used to support the Forms CMS-64 and CMS-21. However, those accounting records did not include the detailed claim information. DHCS officials stated that they could not reconcile the Forms CMS-64 and CMS-21 to the managed care or FFS universes, and the California State Auditor found that the Form CMS-64 was not traceable to individual claims.

We recommended that CMS (1) instruct DHCS to reconcile its PERM universes to the Forms CMS-64 and CMS-21 it submits to CMS and ensure that its universes are complete and accurate, (2) instruct DHCS to implement a payment system that produces information that is readily available, and (3) include steps in the California Financial Management Review to annually reconcile various expenditures on the Forms CMS-64 and CMS-21 to detailed claim information.

In its comments on our draft report, CMS did not agree to implement our first two recommendations and did not specifically address our third recommendation. Without reconciling the PERM universe to the Forms CMS-64 and CMS-21, CMS is unable to show that it has complied with the requirements to produce a statistically valid estimate of improper payments.

Complete Report

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Copies can also be obtained by contacting the Office of Public Affairs at 202-619-1343.

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