MEDDESKTOP: November 2007

Thursday, November 29, 2007

President Global Corp. Recalls Uni-President Red Bean Flavor Ice Bars and Red Bean Tapioca Flavor Ice Bars

Contact:
Mr. Joe Chiang
714-994-2990 x240

FOR IMMEDIATE RELEASE --Buena Park, CA -- November 27, 2007 --- President Global Corporation of Buena Park, CA 90620 is recalling Uni-President Red Bean Flavored Ice Bars (Tung-I Red Bean Flavor Ice Bars) 6/3 fl oz and Red Bean Tapioca Ice Bars (Tung-I Red Bean Tapioca Ice Bars) 6/2.83 fl oz because they may contain undeclared skim milk. People who have allergies to milk run the risk of serious allergic reaction if they consume these products.

The recalled Uni-President Red Bean Flavored Ice Bars and Red Bean Tapioca Ice Bars were distributed in Asian Retail Food Markets in the Southern California area.

Each product comes in a box containing 6 bars. UPC code on boxes of Red Bean Flavor Ice Bars is 4 710608 813600. UPC on boxes of Red Bean Tapioca Ice Bars is 4 710088 070968. There are no expiration dates on the products.

One illness in Canada has been reported to date in connection with this problem.

The recall was initiated after it was discovered that skim milk containing products were distributed in packaging that did not indicate presence of skim milk or milk protein. Distribution of the products has been suspended until FDA and President Global Corp. are certain the problem has been corrected.

Consumers who have purchased Uni-President Red Bean Flavor Ice Bars and Uni-President Red Bean Tapioca Ice Bars are urged to return them to the place of purchase for a full refund or exchange. Consumers with questions may contact the company at ( 714)-994-2990.

Safety Alert on Changes to Prescribing Myfortic (mycophenolic acid) Delayed-Release Tablets

Myfortic (mycophenolic acid) Delayed-Release Tablets: Audience: Oncologists, OB/GYN physicians, other healthcare professionals, patients
[Posted 11/27/2007] Novartis and FDA informed healthcare professionals and patients that use of Myfortic Delayed- Release Tablets during pregnancy is associated with increased risks of pregnancy loss and congenital malformations. The pregnancy category for Myfortic has been changed to Category D (Positive evidence of fetal risk). This change is a result of postmarketing data from the United States National Transplantation Pregnancy Registry and additional postmarketing data collected in women exposed to systemic mycophenolate mofetil (MMF) during pregnancy. MMF is converted to the active ingredient in Myfortic, following oral or intravenous administration.

A patient who is planning a pregnancy should not use Myfortic unless she cannot be successfully treated with other immunosuppressant drugs. Healthcare professionals should discuss the risks and benefits of Myfortic as well as alternative immunosuppressant therapy with the patient. Female patients of childbearing potential must receive contraceptive counseling and must use effective contraception while taking Myfortic. Myfortic is indicated for the prophylaxis of organ rejection in patients receiving allogeneic renal transplants, administered in combination with cyclosporine and corticosteroids.

[November 2007 - Dear Healthcare Professional letter - Novartis]
[October 2007 - Label - Novartis]

Previous MedWatch Alert:
[10/29/2007]

U.S. Consumer Product Safety Commission recalls

Although they are not directly health related recalls, they could lead to health hazards. Listed below a

American Greetings Corp. Recalls Confetti Bursts Due to Violation of Lead Paint Standard

In cooperation with the U.S. Consumer Product Safety Commission (CPSC), American Greetings Corp., of Cleveland, Ohio, is voluntarily recalling about 60,000 DesignWare® Confetti Bursts. The surface paint on the individual bags of confetti contains excessive levels of lead, violating the federal lead paint standard.

Lazy Lounger Chairs and Recliners Sold at Dick's Sporting Goods Recalled for Collapsing Hazard

In cooperation with the U.S. Consumer Product Safety Commission (CPSC), Dick’s Sporting Goods, of Pittsburgh, Pa., is voluntarily recalling about 125,000 Lounge Chairs and Recliners. The plastic support brackets can break and cause the chairs to collapse, posing a hazard to consumers.

Reeves International Inc. Recalls Holiday Ornaments Due to Violation of Lead Paint Standard

In cooperation with the U.S. Consumer Product Safety Commission (CPSC), Reeves International Inc., of Pequannock, N.J., is voluntarily recalling about 36,000 2006 Snow Princess Stirrup Ornaments, 2007 Holiday Stirrup Ornaments, and 2007 Photo Frame Horse Shoe Ornaments. Surface paints on the ornaments contain high levels of lead, violating the federal lead paint standards.

CPSC Warns: Avoid Hazards Related to Holiday Decorating

Holiday decorations, like candles and Christmas trees, add to the festive mood of the season; but when decorations are not used properly, they can result in fires, injuries and death. The U.S. Consumer Product Safety Commission (CPSC) is urging families to keep safety in mind when stringing holiday lights, purchasing Christmas trees, and lighting candles this holiday season.

Children’s Full Zip Hooded Sweatshirts with Drawstrings Recalled for Strangulation Hazard By Bon-Ton

In cooperation with the U.S. Consumer Product Safety Commission (CPSC), The Bon-Ton Department Stores Inc., of York, Pa., is voluntarily recalling about 3,240 Children’s fleece hooded zip-up jackets with neck drawstrings. The garments have a drawstring through the hood, which can pose a strangulation hazard to children. In February 1996, CPSC issued guidelines to help prevent children from strangling or getting entangled on the neck and waist by drawstrings in upper garments, such as jackets and sweatshirts.

“Power Bolt” Pitchbacks Sold at Dick’s Sporting Goods Recalled Due to Laceration Hazard

In cooperation with the U.S. Consumer Product Safety Commission (CPSC), Dick’s Sporting Goods, of Pittsburgh, Pa., is voluntarily recalling about 57,000 “Power Bolt” Y-Frame and Ultimate Y-Frame Adjustable Pitchbacks. The upper portion of the frame can collapse after both locking pins are removed, posing a laceration hazard.

Meijer Inc. Recalls Firepits; Product Can Tip Over and Pose a Fire Hazard

In cooperation with the U.S. Consumer Product Safety Commission (CPSC), Meijer Inc., of Grand Rapids, Mich., is voluntarily recalling about 6,000 Grand Gourmet Firepits. The legs of the firepit can bend or snap off during use, causing the firepit to tip over and in turn the fire can escape. This poses a fire hazard to consumers.

Miter Saws Recalled by WMH Tool Group Due to Laceration Hazard

In cooperation with the U.S. Consumer Product Safety Commission (CPSC), WMH Tool Group Inc. (WMH), of Elgin, Ill., is voluntarily recalling about 7,100 Performax and Wilton 10” Sliding Miter Saws. The saw handle’s switch can fail, causing the saw to smoke, spark, and trip circuit breakers, and disable the safety brake. The saw also can keep operating unless the unit is unplugged, posing a laceration hazard to consumers.

Tips on Reducing Salt Intake

Alicia Moag-Stahlberg, a research nutritionist at Northwestern University Medical School in Chicago and spokeswoman for the American Dietetic Association, offers the following tips for those who want to reduce salt intake:

Take stock of the sources of salt in your diet, such as restaurant meals, salt-based condiments, and convenience foods. Some of these are really loaded with salt.
Read the labels when shopping. Look for lower sodium in cereals, crackers, pasta sauces, canned vegetables, or any foods with low-salt options.
If you think your meals are high in sodium, balance them by adding high-potassium foods, such as fresh fruits and vegetables.
Ask about salt added to food, especially at restaurants. Most restaurant chefs will omit salt when requested.
If you need to salt while cooking, add the salt at the end; you will need to add much less. The longer the food cooks, the more the salty flavor is muted and at the end, the final taste is on the top layer.

More on the complete overview of salt intake at A Pinch of Controversy Shakes Up Dietary Salt

Comment Period for Proposed Sunscreen Rule Extended By FDA

30-day extension to run through Dec. 26, 2007

The Food and Drug Administration today announced that it will be extending the comment period on the agency's proposed sunscreen regulation to Dec. 26, 2007. The comment period was set to expire on Nov. 26. Typically, comment periods for Federal rules is 90 days. The sunscreen rule, when finalized, will amend the 1999 FDA final rule on sunscreen products that protect against ultraviolet B (UVB) rays and incorporates new testing and labeling requirements for products that protect against ultraviolet A (UVA) rays.

On Aug. 27 the agency released to the public its proposed rule for over-the-counter (OTC) sunscreen products. FDA received nine requests to extend the comment period. One asked for an additional two months, eight for an additional nine months. The submissions cited the need for more time to complete laboratory testing and consumer studies on the proposed labeling system. By extending the comment period for 30 days, FDA is balancing industry concerns and the interests of public health to ensure that sunscreen products properly inform consumers of the level of protection they provide against UVA and UVB rays.

Comments must be identified with Docket No. 1978N-0038 and can be submitted electronically or in written form. Electronic submissions can be submitted at the following Web sites:

Federal eRulemaking Portal: www.regulations.gov
FDA Web site: www.fda.gov/dockets/ecomments

Written submissions can be submitted by fax or mail:

Division of Dockets Management
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
Fax 301-827-6870

For more information:
FDA Web site for OTC drug products:
www.fda.gov/cder/Offices/OTC/consumer.htm

Wednesday, November 28, 2007

Consumer Protection, European Style RAPEX

The RAPEX rapid alert system for dangerous consumer products is proving a success throughout Europe. The system is intended to address risks to health and safety through the rapid exchange of information between EU countries. When a non-food product is found to be dangerous, the national authorities notify the commission which can then either ban the product or let it be sold on certain conditions. In April, the EU revealed the results of the 2006 RAPEX report, which highlights a sharp rise in the number of notifications resulting in the withdrawal from the market of many products.

"Have a Safe Christmas" web chat with EU Commissioner for Consumer Policy Kuneva !

EU Commissioner for Consumer Policy Kuneva, has the following message for you.

"I have now been European Commissioner for Consumer Policy for almost a year, and I am convinced there has never been a better time to be a European consumer.

Information is a key element for making you, as Europe's citizens, fully aware of your fundamental rights as consumers. But, awareness alone is not enough. You should be able to play your full role as consumers; confident and able to discuss consumer issues. To this end, I plan to set up a web-chat. We at the Commission must be directly connected to your daily lives and we cannot do that without talking with you.

The subject of our first discussion will be product safety. A number of recent incidents with dangerous toys have created legitimate concerns over the safety of some of the products in the market place.

We cannot compromise on safety. But at the same time we need to be realistic about the real level of risk. I would like to share with you the priorities as I see them in finding the right balance between maximising consumer benefits in terms of price and choice, and minimising consumer risk.

Are the current safety laws good enough?
Do you have enough information on where and how to complain?
Is the returning of products too difficult?
How confident are you when shopping online?

I believe that after our chat on the 5th December we will be more aware of how you see the problems and the possible solutions – it will be an opportunity to bring forward new ideas on which we can all build. It will be your chance to get involved, to become more active and to communicate your ideas and suggestions to me. I very much hope you will take part."

Basic guidance on the Chat:

WHEN? 5th December 2007, from 17:00 – 19:00
WHERE? On this page
WHO? Everybody is invited to participate!
HOW? Language: For your questions to be understood by a large amount of users, you might wish to write in EN, but if not possible you can use FR, DE, IT, and BG
Log in: Register with your name and e-mail address.

Tuesday, November 27, 2007

How Do You Use Your Glucose Meter

November is National Diabetes Awareness Month, an opportunity to raise awareness about this serious disease.

Using a glucose meter to monitor blood sugar is a daily part of life for millions of Americans. Glucose meters are usually small battery-operated devices, which make it convenient for people to check their glucose levels anywhere. Most work by "reading" a drop of blood the user has placed on a disposable test strip.

To begin testing, users place the test strip into a slot in the meter, prick a fingertip and then place a drop of blood onto the strip. Before pricking the skin, the user should clean the selected testing site to ensure it is free of sugar residues. If the site is not clean, the readings may not be accurate.

In a short time, the meter will show a result in its digital display window. Users record their test results and talk with their health care provider to help with overall disease management.

FDA reviews all glucose meters and test strips before they can be marketed to the public. The agency also requires that manufacturers demonstrate that their test system provides acceptable accuracy and consistency of results.

Recently, we have seen the emergence of advanced glucose meters that include features such as download capabilities that allow the transfer of test results to a home computer. Some meters can now test blood taken not from the fingertips, but from "alternate sites" such as the forearm and palm.

Tips for Proper Use

Read instructions carefully. Glucose meters and test strips must come with instructions for use. Your user manual should also include a toll-free phone number that you can use to contact the manufacturer. How often you use your glucose meter, and the results you should expect, should be based on the recommendations of your health care provider .

Know that readings taken from "alternate sites" may not always be as accurate as readings from the fingertips. These readings can differ at times when glucose levels are changing rapidly. This is common after a meal, after taking insulin, during exercise, or when you are ill or under stress.

Use blood from a fingertip rather than an alternate site if you think your blood glucose is low, you don't normally have symptoms when your blood glucose is low, or the results from the alternate site doesn't match how you are feeling.

Know the factors that affect meter accuracy. These may include

the amount of red blood cells (hemocrit) in the blood
other substances present in the blood such as uric acid, glutathione, and vitamin C
altitude, temperature, and humidity
use of test strips developed as a less expensive option than the strips intended for a certain meter.

Perform quality-control checks with test control solutions to ensure that the test strips and meter are working properly together. Some meters may also provide electronic test strips that induce a signal to indicate if the meter (and only the meter) is working properly. In addition, perform quality control checks with control solutions regularly to ensure the meter is working properly.

Ask your health care provider to watch you test yourself. He or she can tell you if you are using the meter correctly.

Know when and how to clean your meter. Some meters need regular cleaning. Others don't need regular cleaning, but contain electronic alerts indicating when you should clean them. You should follow the directions given in the manual on how to clean the meter. Only the manufacturer can clean some meters.

Understand what the meter display means . The range of glucose values can be different among meters. Be sure you know how high and low glucose values are displayed on your meter. Sometimes they are displayed as “LO” or "HI" when the glucose level is beyond the range than the meter can measure.

Report problems to the manufacturer and to FDA. If you suspect that a death or serious injury was related to false glucose readings, follow the mandatory reporting procedure established by your hospital or user facility. Report adverse events not related to serious injuries to the device manufacturer. You can also report events to MedWatch, the FDA's voluntary reporting program at www.fda.gov/medwatch/report.htm.

For More Information

Glucose Meters and Diabetes Management
www.fda.gov/diabetes/glucose.html

Monday, November 26, 2007

Bodee LLC, Inc. Recalls of All Encore Tablets, a Product Marketed as a Dietary Supplement

Contact:
Bodee LLC
(800) 935-0296

FOR IMMEDIATE RELEASE -- Century City, CA – November 21, 2007- Bodee LLC, 2222 Avenue of the Stars, 702E, Century City, CA 90067, announced today that it is conducting a voluntary nationwide recall of all the company's supplement product sold under the name Encore Tabs.

Bodee LLC is conducting this recall after being informed by representatives of the Food and Drug Administration (FDA) that lab analysis by FDA of Encore Tabs samples found the product contains potentially harmful, undeclared ingredients. FDA asserts that its chemical analysis revealed that one lot of Encore Tabs contains aminotadalafil, an analog of tadalafil, the active ingredient of a FDA-approved drug used for Erectile Dysfunction (ED). FDA maintains Aminotadalafil is close in structure to tadalafil and is expected to possess a similar pharmacological and adverse event profile. This undeclared chemical poses a threat to consumers because it may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels.

Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. ED is a common problem in men with these conditions, and consumers may seek these types of products to enhance sexual performance.

Encore Tabs is sold in health food stores, via the internet and by mail order nationwide and in Canada. The Encore Tabs product is sold as a 2-capsule blister pack packaged in a retail booklet with five booklets in a box.

Customers who have this product in their possession should stop using it immediately and contact their physician if they have experienced any problems that may be related to taking this product.

Any adverse events that may be related to the use of this product should be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088 or by fax at 1-800-FDA-0178 or by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787.

The company advises that any unused portion be returned to Bodee LLC for a full purchase price refund by calling (800) 935-0296 for instructions on the return and refund process.

The Company is taking this voluntary action because it is committed and is always concerned with the health of persons who have consumed this product. The Company is reviewing the procedures and policies of all firms involved with the manufacture of the product to ensure that there will be no future issues with regard to Encore Tabs’ composition. The Company is working closely with the FDA in the recall process and is committed to the quality and integrity of its products. It sincerely regrets any inconvenience to consumers and its other customers.

Yes We Are Eating That!

When I read the first part of this New York Times article, I said to myself yes, I do not trust the food I eat. When I go Shopping I read every label. I have written many FDA and USDA postings hoping people will read them and avoid harmful food. It is no wonder only 66% of us trust the food we eat. Down from 82 percent last year. With news of killer spinach, tainted hamburger patties and imported seafood that can provide as many toxins as omega-3s, it is no wonder.
But the wonder was also in the article!
"USA Today pointed out a particularly glaring problem last week. The private laboratories that test foods from companies on the government’s “import alert list” cannot automatically report tainted food to the Food and Drug Administration. Instead, they must give their reports to the importer who is paying for the test. If a shipment fails one laboratory’s test, some importers have switched to a less-reputable laboratory to get the tainted foodstuff through. That cannot be allowed. When labs find a batch of food with too much pesticide or salmonella or worse, they should be required to alert the F.D.A., not hope the companies will come clean for them."
I rest for now before getting mad!
The Food Marketing Institute — with 1,500 members, including major grocery chains and wholesalers — is calling for new rules that would allow the government to recall any food shipment if the producer or importer hesitates. That makes sense to us. Americans need to be a lot more confident that what is on sale at the corner grocery is safe enough to eat.
Read the complete article at NY Times, Are you going to eat that?

Sunday, November 25, 2007

Better Healthcare through Technology? Yes but Give Access to Healthcare First

San Jose Mercury has a news article about how we could have better health care if the medical community adapts the technology, so they can do away with hand written prescriptions and paper medical records. I think the article points to a sector that needs attention. But what need to be done is more than attaching technology to doctors office. They are getting there (By the way my doctor wires in my prescriptions to the pharmacy, has a digital filling system). But what we need, before the technology, is a way for people to get to the doctor. There are millions of uninsured people out there and even the insured people are controlled and mistreated most of the time insurance companies. The medications are based on what the insurance wants to pay, not what the doctor wants.
So I would take, any day, a badly hand written prescription and the risk than not being able to visit a doctor!.
Better Healthcare through Technology? Yes but Give Access to Healthcare First
The article, which is well written and substantiative is here "Technology key for better health care".

National Influenza Vaccination Week, November 26 - December 2, 2007

The Centers for Disease Control and Prevention (CDC) has announced the week after Thanksgiving, November 27 to December 2, as National Influenza Vaccination Week. This event is designed to highlight the importance of continuing influenza (flu) vaccination, as well as foster greater use of flu vaccine through the months of November, December and beyond.

This year, Tuesday November 27, 2007, is set aside as Children’s Flu Vaccination Day, with a focus on vaccinating high-risk children. Each year, over 20,000 children under age 5 are hospitalized as a result of influenza. This day will help raise awareness about the value of vaccinating children—especially high-risk children—and their close contacts.

Every Child By Two (ECBT) seeks to raise awareness about the dangers of influenza and the importance for all parents to have their children vaccinated beginning at six months of age. See the ECBT web site for more information about flu vaccinations or vaccination centers.

Families Fighting Flu, Inc. (FFF) is a non-profit, volunteer-based corporation made up of families and healthcare practitioners who have experienced first-hand the death of a child due to the flu, or have had a child experience severe medical complications from the flu. Through education and advocacy, FFF hopes to improve the rates of annual childhood influenza vaccinations and help reduce the number of childhood illnesses and deaths caused by the flu each year.

Flu Clinic Locator: Provided by the American Lung Association. Find a clinic near you to get your flu vaccine. If this link does not find a clinic near you, your local health department or newspaper may have more information.

American Foods Group, LLC, Recalls Ground Beef Products due to Possible E. Coli O157:H7 Contamination

Congressional and Public Affairs
(202) 720-9113
Amanda Eamich

WASHINGTON, Nov. 24, 2007 - American Foods Group, LLC, a Green Bay, Wisc., firm, is voluntarily recalling approximately 95,927 pounds of various coarse and fine ground beef products because they may be contaminated with E. coli O157:H7, the U.S. Department of Agriculture's Food Safety and Inspection Service announced today.
The following products are subject to recall:

Bulk weight packages of "BEEF, FINE GROUND 73/27." Each shipping label bears a product code of "65000."
Bulk weight packages of "BEEF, FINE GROUND 75/25." Each shipping label bears a product code of "65800."
Bulk weight packages of "BEEF SIRLOIN, FINE GROUND 90/10." Each shipping label bears a product code of "66000."
Bulk weight packages of "BEEF, FINE GROUND 80/20." Each shipping label bears a product code of "66400."
Bulk weight packages of "BEEF, FINE GROUND 75/25." Each shipping label bears a product code of "19900."
Bulk weight packages of "BEEF, FINE GROUND 73/27." Each shipping label bears a product code of "20100."
Bulk weight packages of "BEEF CHUCK, FINE GROUND 82/18." Each shipping label bears a product code of "20600."
Bulk weight packages of "CHOP BEEF STEAK, FINE GRIND "86/14." Each shipping label bears a product code of "30000."
Bulk weight packages of "BEEF SIRLOIN, FINE GROUND 92/08." Each shipping label bears a product code of "30400."
Bulk weight packages of "BEEF ROUND, FINE GROUND 87/13." Each shipping label bears a product code of "30200."
Bulk weight packages of "BEEF, FINE GROUND 80/20." Each shipping label bears a product code of "30700."
Bulk weight packages of "BEEF CHUCK, FINE GROUND 82/18." Each shipping label bears a product code of "31400."
Bulk weight packages of "BEEF, FINE GROUND 93/07." Each shipping label bears a product code of "31600."
Bulk weight packages of "BEEF, FINE GROUND 73/27." Each shipping label bears a product code of "31700."
Bulk weight packages of "BEEF MODIFIED, FINE GROUND 93/07." Each shipping label bears a product code of "31900."

Each shipping label bears the establishment number "Est. 18076" inside the USDA mark of inspection.

The products subject to recall were distributed for further processing and repackaging and will not bear the recalling firm's establishment number on the package. As the use-by date for products subject to this recall may have expired, consumers can contact their retailers to ask if they received any of these products and if so, consumers are urged to look in their freezers for these products and return or discard them if found.

The ground beef products subject to recall were produced on Oct. 10, 2007, and were distributed to retail establishments and distributors in Indiana, Kentucky, Maryland, Ohio, Tennessee, Wisconsin and Virginia.

The problem was discovered through an investigation into two illnesses that was initiated by the Illinois Department of Public Health. Anyone concerned about an illness should contact a physician.

Consumers with questions about the recall should contact the company Executive Assistant Sally VanderHei at (800) 829-2838. National media with questions about the recall should contact company Communications Consultant Jim Mulhern at (703) 553-8000. Local media with questions about the recall should contact company representative Susan Finco at (920) 965-7750.

E. coli O157:H7 is a potentially deadly bacterium that can cause bloody diarrhea and dehydration. The very young, seniors and persons with compromised immune systems are the most susceptible to foodborne illness.

Consumers with food safety questions can "Ask Karen," the FSIS virtual representative available 24 hours a day at AskKaren.gov. The toll-free USDA Meat and Poultry Hotline 1-888-MPHotline (1-888-674-6854) is available in English and Spanish and can be reached from l0 a.m. to 4 p.m. (Eastern Time) Monday through Friday. Recorded food safety messages are available 24 hours a day.

Saturday, November 24, 2007

FDA staff Memo: Asthma drug, SEREVENT DISKUS,safety review recommended

FDA WARNING
Long-acting beta2-adrenergic agonists, such as salmeterol, the active ingredient in SEREVENT DISKUS, may increase the risk of asthma-related death. Therefore, when treating patients with asthma, SEREVENT DISKUS should only be used as additional therapy for patients not adequately controlled on other asthma-controller medications (e.g.,low- to medium-dose inhaled corticosteroids) or whose disease severity clearly warrants initiation of treatment with 2 maintenance therapies, including SEREVENT DISKUS. Data from a large placebo-controlled us study that compared the safety of salmeterol (SEREVENT® Inhalation Aerosol) or placebo added to usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol (13 deaths out of 13,176 patients treated for 28 weeks on salmeterol versus 3 deaths out of 13,179 patients on placebo) (see WARNINGS and CLINICAL TRIALS: Asthma: Salmeterol Multi-center Asthma Research Trial).

DESCRIPTION
SEREVENT DISKUS (salmeterol xinafoate inhalation powder) contains salmeterol xinafoate as the racemic form of the 1-hydroxy-2-naphthoic acid salt of salmeterol. The active component of the formulation is salmeterol base, a highly selective beta2- drenergic bronchodilator. The chemical name of salmeterol xinafoate is 4-hydroxy-a1-[[[6-(4-phenylbutoxy) hexyl]amino] methyl]-1,3-benzenedimethanol, 1-hydroxy-2-naphthalenecarboxylate.
Salmeterol xinafoate has the following chemical structure:
Salmeterol xinafoate is a white to off-white powder with a molecular weight of 603.8, and the empirical formula is C25H37NO4•C11H8O3. It is freely soluble in methanol; slightly soluble in ethanol, chloroform, and isopropanol; and sparingly soluble in water.
SEREVENT DISKUS is a specially designed plastic inhalation delivery system containing a double-foil blister strip of a powder formulation of salmeterol xinafoate intended for oral inhalation only. The DISKUS®, which is the delivery component, is an integral part of the drug product. Each blister on the double-foil strip within the unit contains 50 mcg of salmeterol administered as the salmeterol xinafoate salt in 12.5 mg of formulation containing lactose (which contains milk proteins). After a blister containing medication is opened by activating the DISKUS, the medication is dispersed into the airstream created by the patient inhaling through the mouthpiece.
Under standardized in vitro test conditions, SEREVENT DISKUS delivers 47 mcg when tested at a flow rate of 60 L/min for 2 seconds. In adult patients with obstructive lung disease and severely compromised lung function (mean forced expiratory volume in 1 second [FEV1] 20% to 30% of predicted), mean peak inspiratory flow (PIF) through a DISKUS was 82.4 L/min (range, 46.1 to 115.3 L/min).
The actual amount of drug delivered to the lung will depend on patient factors, such as inspiratory flow profile.

[PDF] Serevent Diskus Label
Page 1. Effective Date: 03/31/2006 SEREVENT® DISKUS® (salmeterol xinafoate
inhalation powder) For Oral Inhalation Only WARNING ...
www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4325b_03_08_Salmeterol%20Label.pdf - 11-23-2007

[PDF] DIVISION DIRECTOR MEMORANDUM
... These are salmeterol xinafoate, marketed as a single ingredient product under the
trade name Serevent and as a combination product with fluticasone propionate ...
www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4325b_03_01_Salmeterol%20BPCA%20Summary.pdf - 11-23-2007

Friday, November 23, 2007

Harry & David recalls Harry and David Moose Munch® Confection Tubs

Harry & David recalls Harry and David Moose Munch® Confection Tubs in Two Flavor Combinations: Milk & Dark Chocolate, White Chocolate Macadamia and Peanut Butter, Milk Chocolate, Macadamia Nut for Undeclared Nut Allergen

Contact:
Mr. Bill Ihle
541 864-2145 (Media Calls Only)

FOR IMMEDIATE RELEASE -- Medford, OR -- November 21, 2007--- Harry & David Operations Corp., of Medford, Oregon, is voluntarily recalling approximately 5880 tubs of the Milk & Dark Chocolate, White Chocolate Macadamia because they may contain macadamia nuts not declared on the ingredient statement, and 4400 tubs of the Peanut Butter, Milk Chocolate, Macadamia Nut because they may contain macadamia nuts and peanuts not declared on the ingredient statement. People who have an allergy or severe sensitivity to these nuts (macadamia or peanut) run the risk of serious or life-threatening allergic reaction if they consume these products.

The products are packaged in 1 lb. 10 oz clear plastic tubs containing three flavors of Moose Munch ® Confection, a caramel corn and chocolate confection.

Harry & David is recalling all Milk & Dark Chocolate, White Chocolate Macadamia with a nutrition label that states Milk Chocolate, Caramel, Dark Chocolate at the top. The potentially affected lot codes are lot codes 304 NXXX NN:NN, 305 NXXX NN:NN, 306 NXXX NN:NN or 307 NXXX NN:NN. In the lot number on the plastic tub, the X is a letter and N is a number.

Harry & David is recalling all Peanut Butter, Milk Chocolate, Macadamia Nut with a nutrition label that states Milk Chocolate, Caramel, Dark Chocolate at the top. The potentially affected lot codes begin with 264 NXXX NN:NN, 265 NXXX NN:NN or 266 NXXX NN:NN. In the lot number on the plastic tub, the X is a letter and N is a number.

The lot codes are ink jetted on the sides of the tubs in black ink.

The Milk & Dark Chocolate, White Chocolate Macadamia was produced from October 31 through November 3 rd, 2007, and was distributed exclusively throughout the United States in Harry and David Stores, beginning on November 9, 2007. The Peanut Butter, Milk Chocolate, Macadamia Nut was produced from September 21 st through September 23 rd, 2007, and was distributed exclusively throughout the United States in Harry and David Stores, beginning on October 10, 2007.

There have been no injuries reported to date. Anyone concerned about a potential illness associated with this product should contact a physician immediately. This problem occurred when tubs with nutrition labels for another product were used for these items.

Consumers with questions about the recalled product may phone the Customer Service division at 800- 233-1101 , 24 hours a day. Customers may arrange for refunds through this number as well.

Sweetwater Valley Farms, Inc. Recalls Southern Cheddar Jack Cheese

Sweetwater Valley Farms, Inc. Recalls Southern Cheddar Jack Volunteer Special Cheese

Contact:
John Harrison
877-862-4332

FOR IMMEDIATE RELEASE -- Philadelphia, TN-- November 21, 2007 --- Sweetwater Valley Farms, Inc. of Philadelphia, TN is recalling Southern Cheddar Jack Volunteer Special Cheese because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.

Southern Cheddar Jack Volunteer Special Cheese, Lot Number 539 was distributed in 7, 10, 15 ounce, and 5 pound blocks and through retail stores in Tennessee, North Carolina, Georgia, Virginia, Maryland, and Alabama. The product was also distributed to 48 contiguous states in gift baskets marketed by the firm’s website.

This product was distributed between September 19, 2006 and November 18, 2007.

No illnesses have been reported.

The recall was the result of a routine sampling program by the Tennessee Department of Agriculture which revealed that the finished product contained the bacteria. The company has ceased the distribution of this lot as the company continues their investigation as to what caused the problem

Consumers who have purchased lot number 539 of this product are urged discard it or ship it back to the company for a full refund. Contact the company’s consumer affairs department at 1-877-862-4332 for further information.

Le Gourmet Connection Recalls Jack Cheese

Contact:
Gary Fort
615-444-3500

FOR IMMEDIATE RELEASE -- Lebanon , TN -- November 21, 2007 --- Le Gourmet Connection of Lebanon, TN is recalling Jack Cheese, lot number 539, because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.

Jack Cheese Lot Number 539 was distributed in 10 ounce blocks and through Jungle Jim’s, Fairfield , Ohio.

This product was distributed between August 28, 2007 and November 19, 2007.

No illnesses have been reported.

Consumers who have purchased this product are urged to discard it and to contact the company at (615) 444-3500 for a full refund.

Early Communication for Chantix

FOR IMMEDIATE RELEASE
November 20, 2007

Media Inquiries:
Rita Chappelle, 301-827-6242
Consumer Inquiries:
888-INFO-FDA

FDA Issues Early Communication for Chantix

Background: The U.S. Food and Drug Administration (FDA) issued an Early Communication about an Ongoing Safety Review of Chantix, a drug approved as an aid to smoking cessation treatment. An Early Communication reflects FDA’s current analysis of available data concerning these drugs and does not mean that FDA has concluded that there is a causal relationship between the drug and the emerging safety issue.

FDA is evaluating postmarketing adverse event reports for Chantix (varenicline), a prescription medicine to help adults stop smoking.

Based on FDA’s request for information from the manufacturer, Pfizer, Inc., the company recently submitted reports to the agency describing suicidal ideation (thoughts). In the wake of a case report citing erratic behavior in an individual who had used Chantix, FDA has also asked the company for any information on additional cases that may be similar in patients who have taken the drug.

FDA’s Center for Drug Evaluation and Research is working to complete an analysis of the available information and data. When this analysis is completed, FDA will communicate the conclusions and recommendations to the public.

In the meantime, FDA recommends that health care providers monitor patients taking Chantix for behavior and mood changes. Patients taking Chantix should contact their doctors if they experience behavior or mood changes.

FDA also advises that, due to reports of drowsiness, patients should use caution when driving or operating machinery until they know how using Chantix may affect them.

Full text of the Early Communication about the Ongoing Safety Review can be found at: http://www.fda.gov/cder/drug/early_comm/varenicline.htm.

FDA Approves Zyrtec for Nonprescription Use

FOR IMMEDIATE RELEASE
November 21, 2007

Media Inquiries:
Rita Chappelle, 301-827-6242
Consumer Inquiries:
888-INFO-FDA

FDA Approves Zyrtec for Nonprescription Use in Adults and Children

The U.S. Food and Drug Administration has approved tablet, chewable tablet, and syrup formulations of Zyrtec (cetirizine HCl) for nonprescription use. The nonprescription drug is approved for the temporary relief of symptoms due to hay fever or other respiratory allergies (sneezing; runny nose; itchy, watery eyes; itchy throat or nose) in adults and children 2 years of age and older.

The nonprescription Zyrtec products also are approved for the relief of itching due to hives in people 6 years of age and older, including adults.

"The approval of Zyrtec for nonprescription use offers an additional treatment option for children and adults," said Andrea Leonard-Segal, M.D., director, Division of Nonprescription Clinical Evaluation in the FDA's Center for Drug Evaluation and Research. "As for all nonprescription drugs, consumers and caregivers should read and carefully follow all directions on the labeling."

The tablets and chewable tablets are approved for adults and children 6 years of age and older:

for the treatment of the symptoms of hay fever and other respiratory allergies, and
to relieve the itching due to hives.

The syrup is approved for:

adults and children 2 years of age and older for the treatment of the symptoms of hay fever and other respiratory allergies, and
adults and children 6 years of age and older to relieve the itching due to hives.

The company will market two distinct Zyrtec products for each dosage form. One will provide directions for treating the symptoms of hay fever and other respiratory allergies. The other will contain directions for use to relieve the itching due to hives.

Zyrtec may cause drowsiness in some people at recommended doses. Other common side effects include fatigue and dry mouth.

On November 9, 2007, the FDA announced that it had approved Zyrtec-D, a product which contains cetirizine HCl and pseudoephedrine HCl, for nonprescription use. Sales of the Zyrtec-D are subject to restrictions in the Combat Methamphetamine Epidemic Act. This law places restrictions on the sale of products containing pseudoephedrine, such as limiting the amount that an individual can purchase, and imposing record keeping requirements on the retail establishments that sell the product and that it be located with the pharmacist. Nonprescription Zyrtec-D was approved for the relief of symptoms due to hay fever or other upper respiratory allergies such as runny nose, sneezing, itchy, watery eyes, itching of the nose or throat, and nasal congestion. Zyrtec-D is also approved for reducing swelling of nasal passages, for relief of sinus congestion and pressure, and for restoring freer breathing through the nose due to hay fever and other upper respiratory allergies. Zyrtec-D is not approved for the relief of itching due to hives.

Zyrtec is marketed and distributed by McNeil Consumer Healthcare, based in Fort Washington, Pa.

Thursday, November 22, 2007

Solarion: Solar Toothbrush will allow you to toss tooth paste!

Solar power will aid in kepping yoour mouth clean. A new solar toothbrush will keep toothpaste away.
Solarion: Solar Toothbrush will allow you to toss tooth paste!

ThanksGiving Day is Recall Filled

I was very sad that I had to post about 12 recalls today and 10 of them are related to childrens toys or jewelry. I went toy buying a few weeks ago and I could not fond any toys that are not made in China. Sorry about the discrimination but most of the recalled products came from China. I do not bother at all if it is made in China, just reject, toys, food, other stuff. There are some stuff that are made in China that I buy, because I have no other choice. But I do not blame China for only for these issues. Like Mattel, the marketing companies, toy companies and distributors, order products from China. These products have design, manufacturing guidelines. It is Chinese manufacturers responsibility to follow those guide lines. More so the responsibility of companies like Mattel to check the products that they are getting.
Sometimes I wonder, if they ordered the products just as they were produced, meaning inferiority of the product was in designing and ordering. May be lobbying is too strong here to ban Lead based paints it toys or other items that children use.
At least be thankful to FDA and CPSC and other agencies for letting us know about these recalls.
Here are the posts that were published today;
Flashing Pacifiers Recalled By Sailing
Children’s Pencil Pouches Recalled by Raymond Geddes & Co.
Children's Metal Jewelry Recalled by Buy-Rite
Cherrydale Fundraising Recalls Bracelets
Children’s Metal Jewelry Recalled by Colossal Jewelry & Accessories
La Femme NY Inc. Recalls Children’s Necklace and Earring Sets
Metal Jewelry Sold at Michaels Stores Recalled
Discount School Supply Recalls Paint Brushes
Metal Jewelry Sold by Family Dollar Stores Recalled
Children's Snow and Sand Castle Kits by Paricon Recalled by L.L. Bean’s
Allergy Alert and Recall of Charlemagne Dark Chocolate Organic Bars
Heartland® Brand Graham Pie Crusts Allergy Alert

Flashing Pacifiers Recalled By Sailing

FOR IMMEDIATE RELEASE
November 21, 2007
Release #08-099

Firm’s Recall Hotline: (800) 643-6134
CPSC Recall Hotline: (800) 638-2772
CPSC Media Contact: (301) 504-7908

Flashing Pacifiers Recalled By Sailing (U.S.) International Corp. Due to Choking Hazard

WASHINGTON, D.C. - The U.S. Consumer Product Safety Commission, in cooperation with the firm named below, today announced a voluntary recall of the following consumer product. Consumers should stop using recalled products immediately unless otherwise instructed.

Name of Product: Flashing Pacifiers or 2-in-1 Flashing Pacifiers with Whistle Necklaces

Units: About 8,000

Importer/Wholesaler: Sailing (U.S.) International Corp., of Hackensack, N.J.

Hazard: The nipple can detach from the base, posing a choking hazard to young children.

Incidents/Injuries: None reported.

Description: The recalled pacifier necklace has a 28-inch multicolored cord with a 3- inch plastic pacifier that comes in assorted colors. A hole at the tip of the nipple is used as a blow hole for the whistle. The pacifier handle operates as the on-off button for the flashing light on both pacifiers. “Flashing Pacifier” or “2-in-1 Flashing Pacifier with Whistle Necklace” is printed on the packaging of the pacifiers.

Sold at: Various retail stores nationwide during the month of June 2007 for about $5 per dozen.

Manufactured in: China

Remedy: Consumers should immediately stop using the pacifiers and return them to the store where purchased to receive a full refund or discard the pacifiers.

Consumer Contact: For additional information, contact Sailing (U.S.) International Corp. at (800) 643-6134 between 9 a.m. and 6 p.m. ET Monday through Friday, or visit the firm’s Web site at www.sailingusintl.com

Children’s Pencil Pouches Recalled by Raymond Geddes & Co.

FOR IMMEDIATE RELEASE
November 21, 2007
Release #08-096

Firm’s Recall Hotline: (800) 533-6273
CPSC Recall Hotline: (800) 638-2772
CPSC Media Contact: (301) 504-7908

Children’s Pencil Pouches Recalled by Raymond Geddes & Co. Due to Violation of Lead Paint Standard

Name of Product: Children’s Pencil Pouches

Units: About 84,200

Distributor: Raymond Geddes & Co., of Baltimore, Md.

Hazard: The paint on the pencil pouches’ zipper pulls contains excessive levels of lead, violating the federal lead paint standard.

Incidents/Injuries: None reported.

Description: The recall includes “Stuff Keepers” pencil pouches and “Bear Pencil Pouches.” The “Stuff Keepers” pencil pouches are clear vinyl, measure 9 inches by 6 inches, and have a green, orange, pink or blue-colored zipper. Style number 63525 is printed on the packaging. The “Bear Pencil Pouches” have soft fabric with a stuffed bear face, and measure 9 inches by 3 inches. Style number 67221 is printed on the packaging.

Sold by: School supply distributors in schools nationwide from September 1997 through October 2007 for between 50 cents and $2.

Manufactured in: China

Remedy: Consumers should immediately take the recalled pencil pouches away from children and return them to the store where purchased for a full refund. If unable to return to the store where purchased, contact Raymond Geddes & Co. directly.

Consumer Contact: For additional information, contact Raymond Geddes & Co. at (800) 533-6273 x1124 between 8 a.m. and 5 p.m. ET Monday through Friday, visit the firm’s Web site at www.raymondgeddes.com/psa.html, or email the firm at consumeraffairs@raymondgeddes.com

Children's Metal Jewelry Recalled by Buy-Rite

FOR IMMEDIATE RELEASE
November 21, 2007
Release #08-095

Firm’s Recall Hotline: (888) 777-7952
CPSC Hotline: (800) 638-2772
CPSC Media Contact: (301) 504-7908

Children's Metal Jewelry Recalled by Buy-Rite Due to Risk of Lead Exposure

Name of Product: Sparkle City Charm Bracelets and Tack Pin Sets

Units: About 43,000

Importer: Buy-Rite Designs Inc., of Freehold, NJ

Hazard: The recalled jewelry contains high levels of lead. Lead is toxic if ingested by young children and can cause adverse health effects.

Incidents/Injuries: None reported.

Description: The recalled charm bracelets have silver-colored star and butterfly charms, and clear and pink beads that hang from a silver-colored chain. The tack pins are silver butterflies or stars with clear and pink beads.

Sold at: Big Lots stores nationwide from August 2005 through April 2007 for about $1.

Manufactured in: China

Remedy: Consumers should immediately take the recalled jewelry away from children and return it to the store where purchased for a full refund. If unable to return it to the stores, contact Buy-Rite for information on how to receive a refund.

Consumer Contact: For additional information, contact Buy-Rite at (888) 777-7952 between 9 a.m. and 5 p.m. ET Monday through Friday, or visit the firm’s Web site at www.buyriteinc.com

Note: CPSC was alerted to this hazard by the New York State Attorney General’s Office.

Cherrydale Fundraising Recalls Bracelets

FOR IMMEDIATE RELEASE
November 21, 2007
Release #08-094

Firm’s Recall Hotline: (800) 333-2565
CPSC Hotline: (800) 638-2772
CPSC Media Contact: (301) 504-7908

Cherrydale Fundraising Recalls Bracelets Due to Risk of Lead Exposure

Name of Product: Decorative Stretchable Aqua Bracelets

Units: About 45,000

Importer: Cherrydale Fundraising, of Allentown, Pa.

Hazard: The bracelets contain high levels of lead. Lead is toxic if ingested by young children and can cause adverse health effects.

Incidents/Injuries: None reported.

Description: The recalled bracelets are stretchable, with silver-colored square links and aqua-colored beads. SKU#5384706813 is printed on the packaging.

Sold at: Various dollar stores, liquidators, and schools as part of fundraising, nationwide from September 2003 through April 2007 for between $1 and $12.

Manufactured in: China

Remedy: Consumers should immediately stop using the recalled bracelets and take them away from young children. Return them to the store where purchased or contact the firm to receive a full refund.

Consumer Contact: For additional information, contact Cherrydale Fundraising at (800) 333-2565 between 8 a.m. and 4:30 p.m. ET Monday through Friday, or visit the firm’s Web site at http://www.cherrydale.com (Microsoft Word).

Note: CPSC was alerted to this hazard by the New York State Attorney General’s Office.

Children’s Metal Jewelry Recalled by Colossal Jewelry & Accessories

FOR IMMEDIATE RELEASE
November 21, 2007
Release #08-093

Firm’s Recall Hotline: (888) 808-5093
CPSC Hotline: (800) 638-2772
CPSC Media Contact: (301) 504-7908

Children’s Metal Jewelry Recalled by Colossal Jewelry & Accessories Due to Risk of Lead Exposure

Name of Product: Children’s Metal Necklaces and Bracelets

Units: About 10,400

Manufacturer: Colossal Jewelry & Accessories Inc., of Maywood, N.J.

Hazard: The recalled jewelry contains high levels of lead. Lead is toxic if ingested by young children and can cause adverse health effects.

Incidents/Injuries: None reported.

Description: The recalled metal necklaces and bracelets have silver-colored charms. Some also have colored beads. “Awesome Boutique” or “Share the Love” is printed on some of the jewelry’s packaging. The jewelry includes a necklace with a metal flower-shaped charm that hangs from a pink cord, a metal heart charm bracelet, a metal heart angel charm bracelet with colored beads, a metal bracelet with four heart charms and ruby-colored beads, necklaces with painted hearts that hang from a cord, and necklaces with tiny purses in various colors.

Sold at: Various discount and dollar stores nationwide from January 2005 through June 2007 for about $1.

Manufactured in: China

Remedy: Consumers should immediately take the recalled jewelry away from children and return it to the store where purchased for a full refund.

Consumer Contact: For additional information, contact Colossal Jewelry & Accessories at (888) 808-5093 between 9 a.m. and 5 p.m. ET Monday through Friday, or e-mail the firm at colosssaljewelry@comcast.net

The web site for the company is down. The about us page has more company information.

Note: CPSC was alerted to this hazard by the New York State Attorney General’s Office.

La Femme NY Inc. Recalls Children’s Necklace and Earring Sets

Click on image to enlarge

FOR IMMEDIATE RELEASE
November 21, 2007
Release #08-092

Firm’s Recall Hotline: (866) 667-5369
CPSC Recall Hotline: (800) 638-2772
CPSC Media Contact: (301) 504-7908

La Femme NY Inc. Recalls Children’s Necklace and Earring Sets Due to Risk of Lead Exposure

Name of Product: La Femme NY Children’s Necklace and Earring Sets

Units: 4,500

Manufacturer: La Femme NY 2 Inc., of Brooklyn, N.Y.

Hazard: The recalled jewelry contains high levels of lead. Lead is toxic if ingested by young children and can cause adverse health effects.

Incidents/Injuries: None reported.

Description: The recalled necklace and earring sets have a silver metal chain and a round pendant with a light blue jewel and three jeweled dangling charms.

Sold at: Various dollar stores nationwide from October 2005 to April 2007 for about $1.

Manufactured in: China

Remedy: Consumers should stop using this product immediately and return it to the store where it was purchased to receive a full refund.

Consumer Contact: For additional information, please contact La Femme NY 2 Inc. at (866) 667-5369 between 8 a.m. and 6 p.m. ET Monday through Friday or visit the firm’s Web site at www.lafemmeny.com or e-mail the firm at corp@lafemmeny.net

Note: CPSC was alerted to this hazard by the New York State Attorney General’s Office.

Metal Jewelry Sold at Michaels Stores Recalled

Click image to Enlarge

FOR IMMEDIATE RELEASE
November 21, 2007
Release #08-091

Firm’s Recall Hotline: (800) 536-6312
CPSC Recall Hotline: (800) 638-2772
CPSC Media Contact: (301) 504-7908

Pure Allure Recalls Metal Jewelry Sold at Michaels Stores Due to Risk of Lead Exposure to Children

Name of Product: Crystal Innovations jewelry

Units: About 200,000

Distributor: Pure Allure, of Oceanside, Calif.

Hazard: The recalled metal jewelry contains high levels of lead. Lead is toxic if ingested by young children and can cause adverse health effects.

Incidents/Injuries: None reported.

Description: The recalled products are metal jewelry components. The SKU numbers can be located on the products’ packaging above the barcode. The following Crystal Innovations products are included in the recall:

Butterfly Charm SKU# 10369903
Flip Flop Charm SKU# 10369909
Heart Crystal Closure SKU# 10391027
Heart Princess Closure SKU# 10391029
Seabreeze Clasps SKU# 10391040
Flower HK Crystal/AB Closure SKU# 10391046
Flower HK Princess Closure SKU# 10391048
Flower Rope Seabreeze Toggle SKU# 10391050
Toggles w/Heart Crystal AB SKU# 10391052
Toggles w/heart Princess SKU#10391054
Princess Earring Set SKU# 10391076
Slider Metal Rectangle Abalone SKU#10369900
Charm Open Flower SKU# 10370038
Earring Set Drop Crystal/AB SKU# 10391065
Earring Set Drop Seabreeze SKU# 10391067

Flower Charm SKU# 10369907
Purse-Sunglasses Charm SKU# 10369910
Heart Seabreeze Closure SKU#10391028
Crystal/AB Clasps SKU# 10391039
Princess Clasps SKU# 10391041
Flower HK Seabreeze Closure SKU# 10391047
Flower Rope Crystal/AB Toggle SKU# 10391049
Flower Rope Princess Toggle SKU# 10391051
Toggles w/heart Seabreeze SKU# 10391053
Crystal/AB Earring Set SKU# 10391074
Seabreeze Earring Set SKU# 10391075
Toggle Bracelet SKU# 10370037
Charm Open Cross SKU# 10370039
Earring Set Drop Princess SKU# 10391066

No other Crystal Innovations products or SKU numbers are included in this recall.

Sold at: Michaels Stores nationwide from April 2006 to September 2007 for about $5.

Manufactured in: China

Remedy: Consumers should immediately take these jewelry pieces away from young children and return it to the store where purchased for a full refund.

Consumer Contact: For additional information, contact Pure Allure at (800) 536-6312 between 9 a.m. and 4 p.m. PT Monday through Friday; visit the firm’s Web site at www.pureallure.com/recall or e-mail the firm at info@pureallure.com

Note: CPSC was alerted to this hazard by the New York State Attorney General’s Office.

Discount School Supply Recalls Paint Brushes

FOR IMMEDIATE RELEASE
November 21, 2007
Release #08-090

Firm’s Recall Hotline: (800) 293-9314
CPSC Recall Hotline: (800) 638-2772
CPSC Media Contact: (301) 504-7908

Discount School Supply Recalls Paint Brushes Due to Violation of Lead Paint Standard

Name of Product: Shaving Paint Brushes

Units: About 20,000

Importer: Discount School Supply, of Monterey, Calif.

Hazard: Surface paint on the brush handles can contain excessive levels of lead, violating the federal lead paint standard.

Incidents/Injuries: None reported.

Description: The recall involves a set of six “shaving-style” brushes, which are about 4-inches long. The brushes’ handles are painted blue, purple, orange, yellow, lime green, and pink. The item number #SHVBRSH is printed on the product’s packaging. Brush sets with handles in brown, dark blue, red, green, blue, and black are not included in this recall. The recalled brushes were also included with the “BioColor® Foam Paint Starter Kit” and “Colorations® Foam Paint Starter Kit.”

Sold by: Discount School Supply’s catalog and Web site from May 2004 through August 2007 for about $5. The BioColor® kits were sold from May 2004 through June 2006 for about $60. The Colorations® kits were sold from July 2006 through August 2007 for about $60.

Manufactured in: China

Remedy: Consumers should stop using the brushes immediately and contact Discount School Supply to receive a free replacement brush set.

Consumer Contact: For more information, contact Discount School Supply at (800) 293-9314 between 6 a.m. and 5 p.m. PT Monday through Friday; visit the firm’s Web site at www.discountschoolsupply.com or e-mail the firm at brushrecall@discountschoolsupply.com

Metal Jewelry Sold by Family Dollar Stores Recalled

FOR IMMEDIATE RELEASE
November 21, 2007
Release #08-088

Firm’s Recall Hotline: (800) 547-0359
CPSC Recall Hotline: (800) 638-2772
CPSC Media Contact: (301) 504-7908

Metal Jewelry Sold by Family Dollar Stores Recalled Due to Risk of Lead Exposure to Children

Name of Product: Rachel Rose and Distinctly Basics Assorted Metal Jewelry

Units: About 205,000

Manufacturer: Family Dollar Stores, of Charlotte, N.C.

Hazard: The recalled jewelry contains high levels of lead. Lead is toxic if ingested by young children and can cause adverse health effects.

Incidents/Injuries: None reported.

Description: The recalled jewelry was sold under the Rachel Rose and Distinctly Basics brands and includes key rings and pins with religious themes (crosses and fish symbols), key rings with "Mom" and cheerleader charms; bracelets with charms like handbags, flip flops, hearts, dresses, and flowers; silver-colored rings with designs or stones in a variety of colors; clutchless hoop earrings with decorations such as butterflies; and filigree and long drop earrings with stones in a variety of colors.

Sold at: Family Dollar stores nationwide from January 2003 through August 2007 for between $.50 and $2. A complete list of the recalled jewelry can be found at www.familydollar.com

Manufactured in: China

Remedy: Consumers should immediately take the recalled jewelry away from children and return it to a Family Dollar store for a full refund.

Consumer Contact: For additional information, contact Family Dollar at (800) 547-0359 between 8:30 a.m. and 5 p.m. ET Monday through Friday, or visit the firm’s Web site at www.familydollar.com

Note: The New York Attorney General provided information about one of these products to the Commission.

Children's Snow and Sand Castle Kits by Paricon Recalled

November 21, 2007
Alert #08-519

Children's Snow and Sand Castle Kits by Paricon Recalled Due to Sharp Edges; Sold Exclusively at LL Bean

The following product safety recall was voluntarily conducted by the firm in cooperation with the CPSC. Consumers should stop using the product immediately unless otherwise instructed.

Name of Product: Snow and Sand Castle Kits

Units: About 800

Manufacturer: Paricon Inc., of South Paris, Maine

Hazard: The largest plastic castle block maker in the kit could crack at the handle during use, creating sharp edges that can pose a laceration hazard to young children.

Incidents/Injuries: No injuries have been reported.

Description: The recall castle kit consists of three red plastic block makers. Only the largest block maker in the set is included in the recall. The largest block maker measures about 19 inches in length and 5 inches in width. Smaller block maker blocks and castle kits with the letter “A” on the inside of the large block maker are not included in this recall.

Sold by: L.L. Bean retail stores nationwide, catalogs and internet from September 2007 through October 2007 for about $30.

Manufactured in: United States

Remedy: Consumers should stop using the large blocks and immediately take these recalled toys away from children. Letters will be sent to each customer with a replacement large castle block maker and a return mailer enclosed. In addition the notice will be posted in L.L. Bean retail stores and on its web site, and customers can return the kit to any retail store for a replacement.

Consumer Contact: For additional information, please contact Paricon at (800) 873-8452 between 8 a.m. and 5 p.m. ET Monday through Friday, or visit L.L. Bean’s Web site at www.llbean.com

Allergy Alert and Recall of Charlemagne Dark Chocolate Organic Bars

Contact:

Belgium ’s Best Chocolates, Inc
781-283-5787

FOR IMMEDIATE RELEASE -- November 20, 2007--- Charlemagne Chocolatiers of Belgium is voluntarily recalling its dark chocolate organic bars currently on the US market, because it may contain undeclared milk protein. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products. Charlemagne Organic Bars are distributed in the US by Belgium’s Best Chocolates, Inc. and were shipped to retail stores in the following states: MI, CA, NJ, NY and MA. Approximately 5000 units of dark Charlemagne organic chocolate bars were distributed. The following chocolate bars are affected:

- Charlemagne Dark with Coffee 50 gr.(1.75 oz.) (UPC= 5 425001 204038)
- Charlemagne Dark with Cinnamon 50 gr.(1.75 oz.) (UPC= 5 425001 204052)
- Charlemagne Dark with Orange 50 gr.(1.75 oz.) (UPC= 5 425001 204021)
- Charlemagne Dark with Green tea 50 gr.(1.75 oz.) (UPC= 5 425001 204045)
- Charlemagne Plain Dark with Belize Chocolate. 50 gr.(1.75 oz.) (UPC= 5 425001 204014)

No illnesses have been reported to date in the US. The Charlemagne Organic dark chocolate bars were tested for milk protein in the US by FDA after a recall was initiated in Canada. The organic dark chocolate bars were distributed in packaging that did not list milk protein in the ingredients or allergen statement.

Consumers that have purchased Charlemagne Organic Dark chocolate products can return it to the place of purchase for a full refund. Consumers with questions may contact the US distributor at 1-877-INDULGE.

Heartland® Brand Graham Pie Crusts Allergy Alert

Contact:

Mike Gloekler
(423) 238-7111, Ext. 22440

FOR IMMEDIATE RELEASE -- Collegedale, TN -- November 19, 2007 --- Blue Planet Foods Inc., of Collegedale, Tenn., is recalling 3,898 individual retail units of Heartland® brand Graham Pie Crusts because they contain undeclared almonds, milk and coconut. People who have an allergy or severe sensitivity to almonds, milk or coconut run the risk of serious or life-threatening allergic reaction if they consume these products.

The Heartland ® brand Graham Pie Crusts were distributed through retail stores nationwide.

The Heartland ® brand Graham Pie Crust is a ready-to-eat pie crust, packaged in a foil pie tin with clear plastic cover and labeled “Heartland ® Graham Pie Crust.” The pie crust has a net weight of 6 oz. (170g). Affected pie crusts are limited to those with freshness dates reading: “Best By Oct 27 2008 1” or “Best By Oct 27 2008 3.”

No illnesses have been reported. For most consumers, there is no safety issue with the pie crusts.

The recall was initiated after it was discovered that product containing almonds, milk and coconut was distributed in packaging that did not reveal the presence of almonds, milk and coconut. Subsequent investigation indicates that the problem was caused by a temporary application of an incorrect label.

Consumers who have purchased this product are urged to contact the company’s consumer affairs department toll-free at 1-877-885-6650 for a full refund.

Wednesday, November 21, 2007

Pedometer will aid you walk further and longer, making you healthier.

I got one of these pedometers as a present last year! I have been using it together with my partner and she has one as well. What we already knew has been proved in a study conducted by a number of experts in the field. The report and information as provided by JAMA is below. The pedometer creates a competition with others as well as with your self to increase number of steps that you take. The other information such as how much calories you burnt makes you want to burn a little more, or walk that fat cheese cake you had for dessert. With or without Pedometer, walking, running, exercising will keep you healthy. I think my insurance company must love me. I am rarely seen at my doctor's office, other than for checkups!, strains, otherwise plain old healty. All due to keeping yourself up with some sort of exercise program. If you think that it might help you, go get one of those pedometers, you will certainly will walk more, if you are that challenging type.

Using Pedometers to Increase Physical Activity and Improve Health

A Systematic Review

Dena M. Bravata, MD, MS; Crystal Smith-Spangler, MD; Vandana Sundaram, MPH; Allison L. Gienger, BA; Nancy Lin, ScD; Robyn Lewis, MA; Christopher D. Stave, MLS; Ingram Olkin, PhD; John R. Sirard, PhD

JAMA. 2007;298(19):2296-2304.

Context Without detailed evidence of their effectiveness,pedometers have recently become popular as a tool for motivatingphysical activity.

Objective To evaluate the association of pedometer usewith physical activity and health outcomes among outpatientadults.

Data Sources English-language articles from MEDLINE, EMBASE,Sport Discus, PsychINFO, Cochrane Library, Thompson Scientific(formerly known as Thompson ISI), and ERIC (1966-2007); bibliographiesof retrieved articles; and conference proceedings.

Study Selection Studies were eligible for inclusion ifthey reported an assessment of pedometer use among adult outpatients,reported a change in steps per day, and included more than 5participants.

Data Extraction and Data Synthesis Two investigators independentlyabstracted data about the intervention; participants; numberof steps per day; and presence or absence of obesity, diabetes,hypertension, or hyperlipidemia. Data were pooled using random-effectscalculations, and meta-regression was performed.

Results Our searches identified 2246 citations; 26 studieswith a total of 2767 participants met inclusion criteria (8randomized controlled trials [RCTs] and 18 observational studies).The participants' mean (SD) age was 49 (9) years and 85% werewomen. The mean intervention duration was 18 weeks. In the RCTs,pedometer users significantly increased their physical activityby 2491 steps per day more than control participants (95% confidenceinterval [CI], 1098-3885 steps per day, P < .001).Among the observational studies, pedometer users significantlyincreased their physical activity by 2183 steps per day overbaseline (95% CI, 1571-2796 steps per day, P < .0001).Overall, pedometer users increased their physical activity by26.9% over baseline. An important predictor of increased physicalactivity was having a step goal such as 10 000 steps perday (P = .001). When data from all studies were combined,pedometer users significantly decreased their body mass indexby 0.38 (95% CI, 0.05-0.72; P = .03). This decreasewas associated with older age (P = .001) and havinga step goal (P = .04). Intervention participants significantlydecreased their systolic blood pressure by 3.8 mm Hg (95% CI,1.7-5.9 mm Hg, P < .001). This decrease was associatedwith greater baseline systolic blood pressure (P = .009)and change in steps per day (P = .08).

Conclusions The results suggest that the use of a pedometeris associated with significant increases in physical activityand significant decreases in body mass index and blood pressure.Whether these changes are durable over the long term is undetermined.

Author Affiliations: Center for Primary Care and Outcomes Research (Drs Bravata and Lin and Mss Sundaram, Gienger, and Lewis), Department of Internal Medicine (Dr Smith-Spangler), Stanford University School of Medicine, Lane Medical Library (Mr Stave), and Department of Statistics (Dr Olkin), Stanford University, Stanford; Department of Internal Medicine, California Pacific Medical Center, San Francisco (Dr Bravata); Veterans Affairs Palo Alto Health Care System, Palo Alto, California (Ms Sundaram); and School of Public Health, University of Minnesota, Minneapolis (Dr Sirard).

Pedometer will aid you walk further and longer, making you healthier.

JAMA

GlaxoSmithKline to acquire Reliant Pharmaceuticals, London Stock Exchange Announcement

Wednesday 21 November 2007, London, UK, Philadelphia, PA & Liberty Corner, NJ - GlaxoSmithKline and Reliant Pharmaceuticals Inc. announced today that they had reached an agreement under which Reliant will be acquired by GSK for $1.65 billion (£800 million) in cash.

Reliant, a privately held specialty pharmaceutical company focused on cardiovascular therapies, recorded net sales of $341 million in the nine months ending 30 September 2007, an increase of 62% over the comparable time period a year earlier.

GSK expects the transaction will be slightly accretive to earnings in 2008, excluding integration costs, and will create additional value in following years.

Through its strategic in-licensing and development strategy, Reliant has developed a portfolio of specialty medicines combating heart disease, including US rights to Lovaza™ (omega-3-acid ethyl esters), a treatment for adult patients with very high levels of triglycerides. Triglycerides are fatty substances in the blood associated with increased risks of coronary artery disease. Lovaza is indicated as an adjunct to diet to reduce triglyceride levels in adults with very high (³500 mg/dL) triglyceride levels.

High lipid levels continue to be a growing health problem in the United States, with up to 5 million people having triglyceride levels classified as very high. Lovaza is the only prescription omega-3 medicine approved by the US Food and Drug Administration for the treatment of very high triglycerides, and remains the only omega-3 medicine that, along with diet and exercise, has been clinically proven to provide a 45% reduction in triglycerides in adult patients with very high triglyceride levels.

Launched in late 2005, Lovaza (formerly known as Omacor®) achieved rapid uptake among patients and healthcare professionals. In the nine months ending 30 September 2007, net sales were $206 million, an increase of 115% over the first nine months of 2006.

Lovaza competes in the non-statin dyslipidemia segment of the US cardiovascular market, where it had achieved a 10% market share of total prescriptions as of 30 September 2007. Sales in the non-statin dyslipidemia market totaled approximately $2.2 billion in 2006 and are expected to grow in excess of 20% a year. GSK believes there is significant opportunity for future growth of Lovaza in this market segment.

Reliant licensed the rights to Lovaza in the US and Puerto Rico from Pronova BioPharma ASA (Oslo: PRON), a publicly traded Norwegian company that will continue to supply the product’s primary material. Rights to Lovaza in other markets have been licensed by Pronova to several other companies.

Commenting on the acquisition agreement, Chris Viehbacher, President, US Pharmaceuticals, GSK, said, “The addition of Lovaza to the GSK portfolio adds a new driver of sales growth in the USbusiness. It represents a strong strategic fit, complementing Coreg CR®, a leading treatment for heart failure and hypertension, and adds to our growing profile in the cardiovascular disease area.”

“Today is a momentous date for Reliant,” said Bradley T. Sheares, CEO of Reliant. “We are very proud of the work that our employees have done to build this company, particularly the energy and perseverance of our sales teams, who have demonstrated their worth in building a formidable Lovaza franchise in less than 24 months. We see great additional potential through this acquisition for Lovaza and the patients who could benefit from it.”

The acquisition is subject to approval by the US Federal Trade Commission and is expected to conclude before year-end.

In addition to Lovaza, Reliant Pharmaceuticals, based in Liberty Corner, NJ, currently markets three other in-licensed cardiovascular products – high blood pressure treatments DynaCirc CR® (isradipine) and InnoPran XL® (propanolol HCl), as well as Rythmol SR® (propafenone), which treats abnormal heart rhythms, or arrhythmia.

Tuesday, November 20, 2007

ABC’s of Toy Safety, A Guide From U.S. Consumer Product Safety Commission (CPSC)

WASHINGTON, D.C. - As gift-givers shop for that perfect toy this holiday season, the U.S. Consumer Product Safety Commission (CPSC) is emphasizing the importance of shopping safely. Knowing your ABC’s of toy safety will make for happy holidays: (A) awareness, and knowing the (B) benefits, for (C) consumers – (Awareness Benefits Consumers).

Awareness is not only knowing there is a CPSC and what the agency does to protect consumers but also being aware of what poses the greatest risks. The leading causes of toy-related fatalities include choking and aspiration of toy parts.

The increased scrutiny of toys and the CPSC has led to B, or benefits, to consumers. CPSC has increased the agency’s inspections of toys and is taking the action needed to remove violative products from the marketplace. More companies are testing their products and reporting possible safety problems.

The Chinese government has signed new agreements to conduct pre-export inspections to prevent lead painted toys and other unsafe toys from being exported to the U.S.

“CPSC recalled 61 toys involving more than 25 million product units in 2007, underscoring CPSC’s daily commitment to keeping consumers safe 365 days a year,” said Acting CPSC Chairman Nancy Nord. “Toys today are undergoing more inspection and more intense scrutiny than ever before.”

Finally C, consumers should stay informed and be aware of recalls by signing up to receive direct e-mail notification of recalls at www.cpsc.gov. CPSC has launched a “Drive to 1 Million” to sign up at least 1 million consumers to receive this direct notification.

Consumers can also be more aware by shopping with CPSC's Top Safe Shopping Tips for this year:

Ride-on Toys – Riding toys, skateboards and in-line skates go fast and falls could be deadly. Helmets and safety gear should be sized to fit.

Small Parts – For children younger than age three, avoid toys with small parts, which can cause choking.

Magnets – For children under age six, avoid building sets with small magnets. If magnets or pieces with magnets are swallowed, serious injuries and/or death can occur.

Projectile Toys – Projectile toys such as air rockets, darts and sling shots are for older children. Improper use of these toys can result in serious eye injuries.

Chargers and Adapters – Charging batteries should be supervised by adults. Chargers and adapters can pose thermal burn hazards to children.

To choose appropriate toys for children:

Be a label reader. Look for toy labels that give age and safety recommendations and use that information as a guide.

Select toys to suit the age, abilities, skills and interest level of the intended child. Look for sturdy construction, such as tightly-secured eyes, noses and other potential small parts.

For all children under 8, avoid toys that have sharp edges and points.

Once the gifts are open:

Immediately discard plastic wrappings on toys before they become dangerous play things.

Keep toys appropriate for older children away from younger siblings or neighbors.

Pay attention to instructions and warnings on battery chargers. Some chargers lack any device to prevent overcharging.

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Send the link for this page to a friend! The U.S. Consumer Product Safety Commission is charged with protecting the public from unreasonable risks of serious injury or death from more than 15,000 types of consumer products under the agency's jurisdiction. Deaths, injuries and property damage from consumer product incidents cost the nation more than $700 billion annually. The CPSC is committed to protecting consumers and families from products that pose a fire, electrical, chemical, or mechanical hazard or can injure children. The CPSC's work to ensure the safety of consumer products - such as toys, cribs, power tools, cigarette lighters, and household chemicals - contributed significantly to the 30 percent decline in the rate of deaths and injuries associated with consumer products over the past 30 years.

To report a dangerous product or a product-related injury, call CPSC's hotline at (800) 638-2772 or CPSC's teletypewriter at (800) 638-8270, or visit CPSC's web site at www.cpsc.gov/talk.html. To join a CPSC email subscription list, please go to www.cpsc.gov/cpsclist.aspx. Consumers can obtain this release and recall information at CPSC's Web site at www.cpsc.gov.

Monday, November 19, 2007

Nexavar for Patients with Inoperable Liver Cancer Approved by FDA

FOR IMMEDIATE RELEASE
November 19, 2007
Media Inquiries:
Christopher DiFrancesco, 301-827-6242
Consumer Inquiries:
888-INFO-FDA

FDA Approves Nexavar for Patients with Inoperable Liver Cancer

The U.S. Food and Drug Administration today announced that it has approved Nexavar (sorafenib) for use in patients with a form of liver cancer known as hepatocellular carcinoma, when the cancer is inoperable. Nexavar was originally approved in 2005 for the treatment of patients with advanced renal cell carcinoma, a form of kidney cancer.
"In a randomized clinical trial, the group of patients with inoperable hepatocellular carcinoma who received Nexavar survived 2.8 months longer than the group of patients who didn't receive the drug,” said Robert Justice, M.D., director of FDA's division of drug oncology products. "This is an important new treatment option for patients who are fighting this very difficult form of cancer." According to the National Library of Medicine, hepatocellular carcinoma accounts for 80 to 90 percent of all liver cancers. This type of cancer can be difficult to remove completely using surgery. If all of the cancer cannot be removed, the disease is usually fatal within three to six months. The American Cancer Society estimates that there will be 19,160 new cases and 16,780 deaths from cancer of the liver and intrahepatic bile duct in the United States in 2007. Nexavar is a type of anticancer drug called a kinase inhibitor. It interferes with molecules that are thought to be involved in chemical messages sent within cancer cells, in the formation of blood vessels that supply tumors, and in cell death. FDA's approval of Nexavar was based on the results of an international randomized placebo-controlled trial in patients with inoperable hepatocellular carcinoma. The study was designed to compare the survival of a group of patients who received the drug against a group of similar patients who did not. A total of 602 patients were studied. Each patient received Nexavar or a placebo. Both groups were comparable with regard to age, gender, race, the stage and other characteristics of their cancer, and the types of cancer treatment they had received before entering the clinical trial. The trial was stopped after a planned interim analysis showed a statistically significant advantage in overall survival for the patients who had received Nexavar. Patients who received Nexavar survived a median of 10.7 months while patients who received placebo survived a median of 7.9 months. A separate analysis showed that tumors progressed more slowly in patients who received Nexavar compared to patients who had received placebo.

The most common adverse reactions that have been observed in patients taking Nexavar (for hepatocellular carcinoma or renal cell carcinoma) are fatigue, weight loss, rash or superficial skin shedding, hand or foot skin reaction, hair loss, diarrhea, anorexia, nausea and abdominal pain. Twenty percent or more of patients had experienced at least one of these reactions. In patients with hepatocellular carcinoma, diarrhea was reported in 55 percent of patients who received Nexavar. Inadequate blood supply to the heart or heart attack were reported in 2.7 percent of patients who received Nexavar, compared to 1.3 percent for patients who received placebo. New high blood pressure was reported in 9 percent of patients who received Nexavar, compared to 4 percent of patients who received placebo. Elevated serum lipase, an enzyme that measures liver function, occurred in 40 percent of patients who received Nexavar, compared to 37 percent of patients who received placebo, and hypophosphatemia, or low blood levels of phosphate, occurred in 35 percent of patients who received Nexavar, compared to 11 percent of patients who received placebo.Nexavar comes in 200 milligram tablets and the usual dose is two tablets (400 milligrams) taken twice a day on an empty stomach. Nexavar is manufactured by Bayer HealthCare AG, Leverkusen, Germany for Bayer Pharmaceuticals Corporation, West Haven, Conn. and by Onyx Pharmaceuticals, Inc., Emeryville, Calif.

FDA Awards Grants to Three Labs in Food Emergency Response Network (FERN).

The U.S. Food and Drug Administration's Office of Regulatory Affairs (ORA) today announced the award of three lab grants, designed to boost the food screening capabilities and spot radioactive material in food, resulting from deliberate or accidental contamination. These labs are part of the Food Emergency Response Network (FERN).

The three-year grants provide $250,000 a year for supplies, personnel, minor facility upgrades and training. Recipients of the grants are the Texas Department of State Health Services Laboratory, the New York Health Research/New York Department of Health, and the Wisconsin State Laboratory of Hygiene.

FDA's ORA will expand its testing program to address the threat to food safety through radiological terrorism events. ORA has developed radiological screening and analysis methodologies used to evaluate foods and food products.

The grants are targeted toward enhanced detection of radiological contamination and thus enhance the nation's overall capability to rapidly detect and respond to deliberate attacks on the food supply.

The grant awards further expand the FDA's ability to promote the integrated strategy for protecting the nation's food supply through the three core elements of prevention, intervention, and response, as outlined in the agency's Food Protection Plan. These funded labs will be involved in food defense surveillance testing as well as bolstering the FDA's emergency response efforts by increasing the capacity for testing of foods for radioactive contamination, intentional or accidental.

The selected laboratories will receive funds to assist in acquiring supplies, personnel, and facility upgrades. The labs will receive training in current food testing methodologies, participate in method development and validation, proficiency testing, and food defense surveillance assignments.

Two key project areas have been identified for the grant recipients. These areas involve the detection of radioactive contamination, utilizing the most advanced detection systems available.

FERN's mission is to integrate the nation's food-testing laboratories at the local, state, and federal levels into a network able to respond to emergencies involving biological, chemical, or radiological food contamination. The network can respond to emergencies related to agents in food and restore the public's confidence in the food supply.

The Long Island anesthesiologist, who reused syringes, cannot be sued due to Statute of Limitations.

According to a post on NY Daily News, The Long Island pain doc who reused syringes and put hundreds of patients at risk for HIV and hepatitis likely cannot be sued because the state waited nearly three years to alert the affected patients.
Dr. Harvey Finkelstein's misuse of syringes 34 months ago resulted in two known hepatitis C cases. But instead of telling 628 patients that they were at risk, the Plainview, L.I., anesthesiologist hired lawyers to negotiate with the state health department.
The state last week mailed letters to the at-risk patients, urging them to get tested for HIV and hepatitis B and C.
If additional patients do turn out to be infected, the state's statute of limitations - 30 months - would prevent them from suing the pain doctor, said Jeff Korek, president of the New York State Trial Lawyers Association.

Continue to the article on NY Daily News...

Sunday, November 18, 2007

Celgene will Acquire Pharmion for $2.9 Billion

SUMMIT, N.J. & BOULDER, Colo.--(BUSINESS WIRE)--Nov. 18, 2007--Celgene Corporation (Nasdaq: CELG) and Pharmion Corporation (Nasdaq: PHRM) today jointly announced the signing of a definitive merger agreement pursuant to which Celgene has agreed to acquire Pharmion. Under the terms of the merger agreement, Celgene will acquire all of the outstanding shares of Pharmion common stock for $72.00 per share payable in a combination of cash and shares of Celgene common stock. The transaction is expected to be slightly dilutive to earnings in 2008 and accretive in 2009 and beyond.

The acquisition of Pharmion furthers Celgene's strategy to become a global leader in the hematology/oncology field. The transaction brings together three medically meaningful therapies, Revlimid(R), Thalomid(R) and Vidaza(R), treating different patient populations worldwide. These products are expected to generate multiple global revenue streams for accelerated revenue and earnings growth over the next five years.

"The acquisition of Pharmion is an exceptional strategic fit that will expand our role as a leader in hematology and oncology," said Sol J. Barer, PhD, Chairman and Chief Executive Officer of Celgene Corporation. "Our combined global infrastructure will leverage the therapeutic and commercial potential of Pharmion's products, particularly Vidaza, which has the potential to become a major global therapy. By bringing together the talents and resources of both companies, we move closer to our vision of becoming a leading hematology and oncology company in the world, expanding our industry leading programs for safety, access and patient support."

Pharmion is a global drug development company that has built a successful and promising oncology franchise. Pharmion has four products on the market and several in development focused on hematological and solid tumor cancers. Vidaza is approved in the U.S. for myelodysplastic syndromes (MDS). Vidaza has demonstrated unprecedented overall survival benefit for higher-risk MDS patients based on a Phase III trial. Pharmion previously reported that its Phase III study demonstrated that Vidaza extended overall survival by 74 percent as compared to conventional care regimens. Patients receiving Vidaza had a two-year survival rate of 50.8 percent versus 26.2 percent for those in the comparator arm. These results translated into a median survival benefit of 9.4 months (24.4 months versus 15.0 months). Pharmion expects to file a Market Authorization Application (MAA) in Europe for Vidaza in higher-risk MDS before the end of the year.

Additionally, thalidomide (licensed to Pharmion by Celgene to develop and commercialize in Europe and other select countries) is under review by the European Medicines Agency (EMEA) as a therapy in newly diagnosed multiple myeloma. An EMEA action is expected in late 2007 to early 2008. Pharmion's clinical development pipeline includes Amrubicin, a third generation synthetic anthracycline, which is in Phase III development for the treatment of small-cell lung cancer (SCLC) under an approved Special Protocol Assessment (SPA). MGCD0103, a selective histone deacetylase (HDAC) inhibitor is being evaluated in Phase II studies in hematological malignancies as well as in solid tumors.

"The combination of our two product portfolios and organizations represents the opportunity to create a leading global hematology/oncology company," said Patrick J. Mahaffy, President and Chief Executive Officer of Pharmion Corporation. "In particular, I would like to thank the Pharmion employees who have contributed so much to the development of our company and to ensuring that our products are available to improve the lives of cancer patients in the US, Europe, and many international markets. We believe that Celgene is now exceptionally well positioned to take advantage of these efforts, as well as those of its own strong organization, to create a truly unique global biopharmaceutical company."

Terms of the Transaction

The transaction has been unanimously approved by the Boards of Directors of both companies and is subject to customary closing conditions including the approval of the acquisition by stockholders of Pharmion and receipt of antitrust clearances. Celgene and Pharmion expect the transaction to close by the end of the second quarter of 2008. Under the terms of the merger agreement, each share of Pharmion common stock will be exchanged for $25.00 in cash and shares of Celgene common stock in an amount to be determined by an exchange ratio. If the volume weighted average price per share of Celgene common stock for the 15 consecutive trading days ending on (and including) the third trading day immediately prior to the closing date of the merger (the "VWAP Closing Price") is between $56.15 and $72.93, then the exchange ratio will be equal to $47.00 divided by the VWAP Closing Price. If the VWAP Closing Price is less than $56.15, Pharmion stockholders will receive 0.8370 Celgene shares for each share of Pharmion common stock, and if the VWAP Closing Price is greater than $72.93, Pharmion stockholders will receive 0.6445 Celgene shares for each share of Pharmion common stock. The cash portion of the transaction is being funded by Celgene's cash on hand. Upon the closing of the acquisition, Pharmion stockholders will own approximately six percent of Celgene's outstanding common stock.

JPMorgan and Merrill Lynch are acting as co-financial advisors to Celgene on the transaction. Banc of America Securities LLC is acting as the financial advisor to Pharmion Corporation. Legal counsel for Celgene is Proskauer Rose LLP and Arnold & Porter LLP, and Pharmion's legal counsel is Willkie Farr & Gallagher LLP.

Webcast

Celgene will host a conference call to discuss the strategic acquisition of Pharmion Corporation on Monday, November 19, 2007 at 9:00 a.m. ET. The conference call will be available by webcast at www.celgene.com. An audio replay of the call will be available from 12 noon ET November 19, 2007 until 12 midnight ET, Friday, November 23, 2007. To access the replay, dial 1-888-203-1112 and enter reservation number 8078427.

CONTACT: Celgene Corporation
            David Gryska, 908-673-9059
            Sr. Vice President and
            Chief Financial Officer
            or
            Celgene Corporation
            Brian P. Gill, 908-673-9530
            Vice President,
            Corporate Communications
            or
            Pharmion Corporation
            Breanna Burkart/Anna Sussman, 720-564-9150
            Directors, Investor Relations and Corporate Communication

   SOURCE: Celgene Corporation and Pharmion Corporation

Saturday, November 17, 2007

Vaccinate Your Children or Go To Jail

Hundreds of grumbling parents facing a threat of jail lined up at a courthouse Saturday to either prove that their school-age kids already had their required vaccinations or see that the youngsters submitted to the needle.

The get-tough policy in the Washington suburbs of Prince George's County was one of the strongest efforts made by any U.S. school system to ensure its youngsters receive their required immunizations.

Two months into the school year, school officials realized that more than 2,000 students in the county still didn't have the vaccinations they were supposed to have before attending class.

So Circuit Court Judge C. Philip Nichols ordered parents in a letter to appear at the courthouse Saturday and either get their children vaccinated on the spot or risk up to 10 days in jail. They could also provide proof of vaccination or an explanation why their kids didn't have them.

By about 8:30 a.m., the line of parents stretched outside the courthouse in the county on the east side of Washington.

Hobby Lobby Stores Recalls Halloween-Themed Baskets (Lead Paint Standard Violation)

FOR IMMEDIATE RELEASE
November 16, 2007
Release #08-084

Hobby Lobby’s Recall Hotline: (800) 326-7931
CPSC Recall Hotline: (800) 638-2772
CPSC Media Contact: (301) 504-7908

Name of Product: Halloween-Themed Baskets

Units: About 10,000

Importer: Hobby Lobby Stores Inc., of Oklahoma City, Okla.

Hazard: Surface paint on the bat, pumpkin and witch emblems attached to the baskets contain excess levels of lead, which violates the federal lead paint ban.

Incidents/Injuries: None reported.

Description: This recall involves all 2007 Halloween-themed baskets with item number 5464201. The item number is located next to the price on the paper hangtag on the handle. The plastic baskets are either black or orange with two carrying handles. An emblem of a witch, bat or pumpkin is attached to each side of the handle. The baskets measure 3 inches wide by 6 inches long by 4 ½ inches deep.

Sold at: Hobby Lobby stores nationwide from August 2007 through November 2007 for about $1.

Manufactured in: China

Remedy: Consumers should take the baskets away from children immediately and return them to Hobby Lobby for a $2 exchange card.

Consumer Contact: For additional information, contact Hobby Lobby at (800) 326-7931 anytime, or visit the firm’s Web site at www.hobbylobby.com

Potentially Harmful "Cosmetic" Eye Product Age Intervention Eyelash, (by Jan Marini Skin Research) Seized by FDA

At the request of the U.S. Food and Drug Administration, U.S. Marshals seized today 12,682 applicator tubes of Age Intervention Eyelash, a product that may, in some users, lead to decreased vision. Authorities said the sales value of the seized tubes is approximately $2 million.

Age Intervention Eyelash is sold and distributed by Jan Marini Skin Research, Inc., of San Jose, Calif.

The FDA considers Age Intervention Eyelash to be an unapproved and misbranded drug because Jan Marini Skin Research has promoted the product to increase eyelash growth. Before a new drug product may be legally marketed, it must be shown to be safe and effective, and approved by FDA. The agency takes seriously its responsibility to protect Americans from unapproved drugs.

FDA also considers the seized Age Intervention Eyelash to be an adulterated cosmetic. The product contains bimatoprost, an active ingredient in an FDA-approved drug to treat elevated intraocular pressure (elevated pressure inside the eye).

For patients using the prescription drug, using the Age Intervention Eyelash in addition to the drug may increase the risk of optic nerve damage because the extra dose of bimatoprost may decrease the prescription drug's effectiveness. Damage to the optic nerve may lead to decreased vision and possibly blindness.

In addition, use of Age Intervention Eyelash may cause other adverse effects in certain people due to the bimatoprost, including macular edema (swelling of the retina) and uveitis (inflammation in the eye), which may lead to decreased vision.

The U.S. Attorney's Office for the Northern District of California filed the complaint requesting the seizure, and coordinated with the FDA. The California Department of Public Health‘s Food and Drug Branch had previously embargoed the seized products at the San Jose facility. Jan Marini Skin Research has notified FDA that the company ceased manufacturing and shipping any Age Intervention Eyelash product containing bimatoprost last year.

The FDA recommends that consumers, dermatologists, and estheticians who may still have Age Intervention Eyelash discontinue using it and discard any remaining product. FDA also recommends that consumers consult their health care provider if they have experienced any adverse events that they suspect are related to the product's use.

Friday, November 16, 2007

Acute Respiratory Disease Associated with Adenovirus Serotype 14 Detected in Four States

Adenovirus Serotype 14 or Ad14 is a rarely reported but emerging adenovirus serotype that can cause severe and sometimes fatal respiratory illness. In May 2006, an infant in New York died from respiratory illness caused by Ad14. During March--June 2007, a total of 140 additional cases were identified in patients in Oregon, Washington, and Texas; nine of these patients died. Ad14 isolates from the four states were identical to one another but distinct from the Ad14 reference strain from 1955, suggesting emergence of a new Ad14 variant in the United States.

New York

In May 2006, a fatal case of Ad14 illness occurred in New York City in an infant girl aged 12 days. The infant was born after a full-term pregnancy and uncomplicated delivery. She was found dead in bed, where she had been sleeping. The infant had been examined 3 days after birth and noted to have lost weight but was otherwise healthy. The next week she had decreased tears with crying, suggesting early dehydration. Physical activity and feeding progressively decreased during the week before her death.

Postmortem tracheal and gastric swabs from the infant were sent to the Wadsworth Center laboratory of the New York State Department of Health, where adenovirus was detected by polymerase chain reaction (PCR). Adenovirus also was isolated by culture, confirmed by immunofluorescence assay (IFA), and typed as Ad14 by antibody neutralization assay. Analysis at CDC identified the same unique genetic sequences in this isolate as were later identified in the Ad14 isolates from the three 2007 clusters.

Autopsy and histologic findings at the Office of the Chief Medical Examiner in New York City included presence in the lung of chronic inflammatory cells with intranuclear inclusions, consistent with adenoviral bronchiolitis and acute respiratory distress syndrome. Investigation by the New York City Department of Health and Mental Hygiene has not identified any other local cases of Ad14 illness.

Oregon

In early April 2007, a clinician alerted the Oregon Public Health Division (OPHD) regarding multiple patients at a single hospital who had been admitted with a diagnosis of severe pneumonia during March 3--April 6. A total of 17 specimens were obtained from patients; 15 (88%) yielded isolates that were identified by CDC as Ad14. Through retrospective examination of laboratory reports from the three clinical laboratories in the state that have virology capacity and the Oregon State Public Health Laboratory (OSPHL), OPHD identified 68 persons who tested positive (by culture, PCR, or IFA) for adenovirus during November 1, 2006--April 30, 2007. Isolates from 50 (74%) of these patients were available for further adenovirus typing at either CDC or OSPHL. Of the 50 patient isolates, 31 (62%) were identified as Ad14, and 15 (30%) were identified as another adenovirus type (Figure); four (8%) did not test positive for adenovirus.

Among 30 Ad14 patients (i.e., all but one) whose medical charts were reviewed, 22 (73%) were male; median age was 53.4 years (range: 2 weeks--82 years). Five cases (17%) occurred in patients aged <5>18 years. Twenty-two patients (73%) required hospitalization, sixteen (53%) required intensive care, and seven (23%) died, all from severe pneumonia. Median age of the patients who died was 63.6 years; five (71%) were male. One death occurred in an infant aged 1 month. Of the 30 Ad14 cases with patient residence information available, 28 (93%) occurred in residents of seven Oregon counties, and two cases occurred in residents of two Washington counties. No link was identified in hospitals or the community to explain transmission of Ad14 from one patient to another.

In comparison with the Ad14 patients, among the 12 adenovirus non-type 14 patients (i.e., all but three) whose medical charts were reviewed, nine (75%) were male. Median age was 1.1 years, and 11 (92%) patients were aged <5>

Washington

On May 16, 2007, the Tacoma-Pierce County Health Department notified the Washington State Department of Health (WADOH) of four residents housed in one unit of a residential-care facility who had been hospitalized recently for pneumonia of unknown etiology. The patients were aged 40--62 years; three of the four were female. One patient had acquired immunodeficiency syndrome (AIDS); the three others had chronic obstructive pulmonary disease. All four were smokers.

The patients had initial symptoms of cough, fever, or shortness of breath during April 22--May 8, 2007. Three patients required intensive care and mechanical ventilation for severe pneumonia. After 8 days of hospitalization, the patient with AIDS died; the other patients recovered. Respiratory specimens from all four patients tested positive for adenovirus by PCR at the WADOH laboratory; isolates were available from three patients, and all three isolates were identified as Ad14 by CDC. Ad14 had last been identified in an isolate from a patient from Washington in May 2006, marking the first identification of Ad14 in the state since 2004. Active surveillance among facility residents and staff did not identify any other cases of Ad14 illness.

Texas

Since February 2007, an outbreak of cases of febrile respiratory infection* associated with adenovirus infection has been reported among basic military trainees at Lackland Air Force Base (LAFB). During an initial investigation, conducted from February 3 to June 23, out of 423 respiratory specimens collected and tested, 268 (63%) tested positive for adenovirus; 118 (44%) of the 268 were serotyped, and 106 (90%) of those serotyped were Ad14. Before this outbreak, the only identification of an Ad14 isolate at LAFB occurred in May 2006 (1).

During February 3--June 23, 2007, a total of 27 patients were hospitalized with pneumonia (median hospitalization: 3 days), including five who required admission to the ICU. One ICU patient required extracorporeal membrane oxygenation for approximately 3 weeks and ultimately died. All 16 hospitalized patients from whom throat swabs were collected, including the five patients admitted to the ICU, tested positive for Ad14. Fifteen of these hospitalized patients tested negative for other respiratory pathogens, and one patient had a sputum culture that was positive for Haemophilus influenzae.

All health-care workers from hospital units where trainees had been admitted were offered testing for Ad14, regardless of history of respiratory illness. Of 218 health-care workers tested by PCR, six (3%) were positive for Ad14; five of the six reported direct contact with hospitalized Ad14 patients.

Prevention measures implemented during the outbreak included increasing the number of hand-sanitizing stations, widespread sanitizing of surfaces and equipment with appropriate disinfectants, increasing awareness of Ad14 among trainees and staff members, and taking contact and droplet precautions for hospitalized patients with Ad14. Beginning on May 26, trainees with febrile respiratory illness were confined to one dormitory and both patients and staff members were required to wear surgical masks.

Cases reported postinvestigation. Since the investigation, new cases of febrile respiratory illness have continued to occur at LAFB, but the weekly incidence has declined from a peak of 74 cases with onset during the week of May 27--June 2, to 55 cases with onset during the week of September 23--29 (the most recent period for which data were available). In addition, during March--September 2007, three other military bases in Texas that received trainees from LAFB reported a total of 220 cases of Ad14 illness (Air Force Institute for Operational Health, personal communication, 2007). However, whether Ad14 spread from LAFB to these three bases has not been determined. Ad14 also was detected in April in an eye culture from an outpatient in the surrounding community who had respiratory symptoms and conjunctivitis. No link between this case and the LAFB cases was identified.

Reported by: Oregon Dept of Human Svcs. Washington State Dept of Health Communicable Diseases. 37th Training Wing, 59th Hospital Wing, Air Force Institute for Operational Health, Epidemic and Outbreak Surveillance, US Air Force. Naval Health Research Center, US Navy. Texas Dept of State Health Svcs. New York City Dept of Health and Mental Hygiene. Div of Viral Diseases, National Center for Immunization and Respiratory Diseases; Div of Healthcare Quality Promotion, National Center for Preparedness, Detection, and Control of Infectious Diseases; Career Development Div, Office of Workforce and Career Development, CDC.

Editorial Note:

Adenoviruses were first described in the 1950s and are associated with a broad spectrum of clinical illness, including conjunctivitis, febrile upper respiratory illness, pneumonia, and gastrointestinal disease. Severe illness can occur in newborn or elderly patients or in patients with underlying medical conditions but is generally not life-threatening in otherwise healthy adults. Adenoviruses are known to cause outbreaks of disease, including keratoconjunctivitis, and tracheobronchitis and other respiratory diseases among military recruits (2,3). Although adenovirus outbreaks in military recruits are well-recognized (3), infection usually does not require hospitalization and rarely requires admission to an ICU. Beyond the neonatal period, deaths associated with community-acquired adenovirus infection in persons who are not immunodeficient are uncommon and usually sporadic.

Fifty-one adenovirus serotypes have been identified (4). The cases described in this report are unusual because they suggest the emergence of a new and virulent Ad14 variant that has spread within the United States. Ad14 infection was described initially in 1955 (5) and was associated with epidemic acute respiratory disease in military recruits in Europe in 1969 (6) but has since been detected infrequently. For example, during 2001--2002, Ad14 was associated with approximately 8% of respiratory adenoviral infections in the pediatric ward of a Taiwan hospital, with approximately 40% of Ad14 cases in children aged 4--8 years manifesting as lower airway disease (7).

The National Surveillance for Emerging Adenovirus Infections system includes military and civilian laboratories at 15 sites. During 2004--2007, this surveillance system detected 17 isolates of Ad14 from seven sites (8). Ten of the 17 isolates (60%) were collected from three military bases (8). Despite this surveillance, adenovirus infections often go undetected, because few laboratories routinely test for adenovirus and even fewer do serotyping. Wider circulation of Ad14 might have occurred in recent years and might still be occurring.

Further work is needed to understand the natural history of Ad14, risk factors for severe Ad14 disease, and how Ad14 transmission can be prevented effectively. Vaccines against adenovirus serotypes four and seven (i.e., Ad4 and Ad7) were used among military recruits during 1971--1999, before vaccines were no longer available. Adenoviral disease among U.S. military recruits subsequently increased (9). Ad4 and Ad7 oral vaccines have been redeveloped and are being evaluated in clinical trials. Work is ongoing to determine whether the new Ad4 and Ad7 vaccines will protect against Ad14 infection. Management of adenoviral infections is largely supportive. A number of antiviral drugs, including ribavirin, vidarabine, and cidofovir, have been used to treat adenoviral infections such as Ad14, but none have shown definitive efficacy against adenoviruses (2).

Control of adenovirus outbreaks can be challenging because these viruses can be shed in both respiratory secretions and feces and can persist for weeks on environmental surfaces. Guidelines for the care of patients with pneumonia (10) should be followed in cases of suspected adenoviral pneumonia.

Clinicians with questions related to testing of patients for adenovirus or Ad14 infection should contact their state health departments, which can provide assistance. State health departments and military facilities should contact CDC to report unusual clusters of severe adenoviral disease or cases of Ad14 or to obtain additional information regarding laboratory testing.

CDC Repeort

Health Net Fined One Million Dollars and a Class Action Suit might be on the way!

DOW JONES NEWSWIRES

Health Net Inc.'s (HNT) Health Net Life Insurance Co. faces a purported class- action lawsuit alleging that the insurer retroactively canceled the policies of more than 1,600 people to save the company more than $35.5 million, according to lawyer William Shernoff.

According to Shernoff, internal company documents show that a Health Net employee was given an incentive-based goal of 15 rescissions a month in 2002.

Shernoff has asked California Insurance Commissioner Steven Poizner to suspend Health Net's license to sell insurance and said he will request that California State Attorney General Jerry Brown consider criminal charges.

Health Net, Woodland Hills, Calif., received a $1 million fine Thursday from the California Department of Managed Health Care for failing to disclose the employee bonus program. The state agency is still investigating the company and further fines are possible.

Health Net wasn't immediately available for comment.

-Melissa Korn; 201-938-5400; AskNewswires@dowjones.com

Today is Great American Smokeout

Do you need any more reasons for quiting?
Health benefits after quitting

• 20 minutes: Heart rate and blood pressure drops.

• 12 hours: Carbon-monoxide level in blood drops to normal.

• 2 weeks to 3 months: Circulation improves and lung function increases.

• 1 to 9 months: Coughing and shortness of breath decrease.

• 1 year: Excess risk of coronary heart disease is half that of a smoker.

• 5 to 15 years: Stroke risk is reduced to that of a non-smoker.

• 10 years: Lung-cancer death rate is about half that of a continuing smoker.

• 15 years: Risk of coronary heart disease is that of a non-smoker.

Source: U.S. Surgeon General’s report, 1990

Children’s Wooden Storage Rack Recalled By Jetmax International Due to Child’s Death

WASHINGTON, D.C. - In cooperation with the U.S. Consumer Product Safety Commission (CPSC), Jetmax International Ltd., of Irving, Texas is voluntarily recalling about 36,000 boy’s and girl’s storage racks with canvas totes.

The storage rack can tip over, posing an entrapment and suffocation hazard to young children.

CPSC has received one report of a death involving an 8-month-old boy who was asphyxiated after he pulled on the storage rack and it fell over on him. The top rail landed on the infant’s neck. No other incidents have been reported.

The storage rack is wooden with three levels and nine removable canvas totes. There are wooden handles on each side of the rack. The boy’s storage rack has natural color wood with red, yellow, green, and navy canvas totes. The girl’s storage rack has white colored wood with pink, yellow, lime, and purple canvas totes.

Wal-Mart sold the storage rack under the brand “Home Trend Kids 9 Canvas Bin Boy’s and Girl’s Organizers.”

The storage racks were manufactured in China.

They were sold at Wal-Mart stores nationwide from August 2004 through July 2005 and Ollie’s stores nationwide from July 2006 through June 2007 for about $40. Consumers should immediately stop children from using the recalled storage racks and contact Jetmax International to receive a free repair kit that adds stability to the base.

For additional information, contact Jetmax at (800) 689-2168 between 9 a.m. and 5 p.m. CT, visit the firm’s Web site at www.jlwoodenmfg.com, or email info@jlwoodenmfg.com

Bon-Ton Recalls Children’s Bath Robes

Bon-Ton Recalls Children’s Bath Robes Due to Burn Hazard

The following product safety recall was voluntarily conducted by the firm in cooperation with the CPSC. Consumers should stop using the product immediately unless otherwise instructed.

Name of Product: Girls and Boys Bath Robes

Units: About 1,000

Retailer: The Bon-Ton Department Stores Inc., of York, Pa.

Hazard: The recalled bath robes fail to meet the children’s sleepwear flammability standard, posing a risk of burn injuries to children if the robe caught fire.

Incidents/Injuries: None reported.

Description: This recall involves “Miss Attitude” girls bath robes with GPU #5500-K660504 (Solid purple with frog and rainbow appliqué) and GPU # 5500-K660474 (Pink Leopard print) and “URIT” boys bath robes with GPU # 5500-K660495 (Blue solid with sport appliqué) and GPU# 5500-K660496 (Green camouflage print). “URIT,” “Miss Attitude,” and the GPU# can be found in the tags sewn in the center back neck of the garment.

Sold by: Bon-Ton, Bergner’s, Boston Store, Elder-Beerman, Herberger’s, Younkers, and Carson Pirie Scott stores nationwide and Parisian (Detroit area only) from September 2007 through October 2007 for between $25 and $40.

Manufactured in: China

Remedy: Consumers should stop using these children’s robes immediately and return them to any of the stores listed above for a full refund.

Consumer Contact: For additional information, please contact Bon-Ton at (866) 798-2875 anytime, or visit the firm’s Web site at www.bonton.com

Double B Foods, Inc. Recalls Frozen Sausage Roll Products

This is a USDA Class I reacall
USDA's definition of Class I This is a health hazard situation where there is a reasonable probability that the use of the product will cause serious, adverse health consequences or death.
WASHINGTON, Nov. 15, 2007 - Double B Foods, Inc., a Meridian, Texas, firm, is voluntarily recalling approximately 98,000 pounds of frozen sausage roll products that may be contaminated with Listeria monocytogenes, the U.S. Department of Agriculture's Food Safety and Inspection Service announced today.
The frozen sausage roll products were produced on various dates between Oct. 25 and Nov. 6, and were distributed to retail establishments in Texas, and institutions, catalogue sales and distribution centers in Alabama, Arkansas, Florida, Georgia, Louisiana, Mississippi, New Jersey, New Mexico, New York, Oklahoma, Pennsylvania and Texas.

Media and consumers with questions about the recall should contact company Director of Human Resources Rick Borden at (254) 435-6575.
USDA FSIS
Images are for reference only, See link below for original from USDA!

The following product is subject to recall: [View Labels (Available from USDA site,PDF Only Above images are from The same PDF)]

7.5-pound cases of "DOUBLE B FOODS, MORNING SAUSAGE ROLL, Chicken and Turkey Knockwurst Wrapped in the Dough and Baked." Each label bears the establishment number "P-7184M" inside the USDA mark of inspection.
10-pound cases of "DOUBLE B FOODS, MORNING SAUSAGE ROLL, Smoked Knockwurst Wrapped in Dough and Baked." Each label bears the establishment number "EST. 7184M" inside the USDA mark of inspection.
10-pound cases of "DOUBLE B FOODS, SAUSAGE-N-CHEDDAR IN A BLANKET, Smoked Knockwurst with Cheese Baked in Dough." Each label bears the establishment number "EST. 7184M" inside the USDA mark of inspection.
10-pound cases of "DOUBLE B FOODS, REDUCED SODIUM MORNING SAUSAGE ROLL, Chicken and Turkey Knockwurst Wrapped in Dough and Baked." Each label bears the establishment number "P-7184M" inside the USDA mark of inspection.
7.5-pound cases of "DOUBLE B FOODS, REDUCED SODIUM MORNING SAUSAGE ROLL, Chicken and Turkey Knockwurst Wrapped in Dough and Baked." Each label bears the establishment number "P-7184M" inside the USDA mark of inspection.
10-pound cases of "DOUBLE B FOODS, MORNING SAUSAGE ROLL." Each label bears the establishment number "P-7184M" inside the USDA mark of inspection.
8- and 16-ounce packages of "H-E-B SAUSAGE & CHEDDAR KOLACHE, Smoked Sausage with Cheese Baked in Dough." Each package bears a sell by date of "12/13/07" or "12/20/07," as well as the establishment number "EST. 7184M" inside the USDA mark of inspection.
8-pound bags of "H-E-B SAUSAGE & CHEDDAR KOLACHE, Smoked Knockwurst with Cheese Baked in Dough." Each bag bears a sell by date of "7/30/08," "8/01/08" or "8/06/08," as well as the establishment number "EST. 7184M" inside the USDA mark of inspection.
8-pound bags of "H-E-B FULLY COOKED SAUSAGE CHEDDAR & JALAPENO KOLACHES, Smoked Sausage with Cheese Baked in Dough." Each bag bears a sell by date of "7/26/08," "8/1/08" or "8/2/08," as well as the establishment number "EST. 7184M" inside the USDA mark of inspection.
8- and 16-ounce packages of "H-E-B FULLY COOKED SAUSAGE & CHEDDAR KOLACHES, Smoked Sausage with Cheese Baked in Dough." Each package bears a sell by date of "12/16/2007," as well as the establishment number "EST. 7184M" inside the USDA mark of inspection.
8-ounce packages of "H-E-B FULLY COOKED SAUSAGE CHEDDAR & JALAPENO KOLACHES, Smoked Sausage with Cheese Baked in Dough." Each bag bears a sell by date of "12/16/2007," as well as the establishment number "EST. 7184M" inside the USDA mark of inspection.
8-pound bags of "H-E-B SAUSAGE KOLACHE, SMOKED SAUSAGE BAKED IN DOUGH." Each bag bears a sell by date of "8/1/2007," as well as the establishment number "EST. 7184M" inside the USDA mark of inspection.
10-pound cases of "MORNING SAUSAGE ROLL, Knockwurst Wrapped in Dough and Baked." Each label bears a case code of "2370211," as well as the establishment number "EST. 7184M" inside the USDA mark of inspection.
10-pound cases of "SAUSAGE IN A BLANKET, Sausage Wrapped in Dough and Baked." Each label bears a case code of "1332642," as well as the establishment number "EST. 7184M" inside the USDA mark of inspection.
8-ounce packages of "SMOKY'S FULLY BAKED SAUSAGE ROLLS, SAUSAGE & CHEESE." Each label bears the establishment number "EST. 7184M" inside the USDA mark of inspection.
2.25-pound packages of "SOUTHERN HERITAGE, SAUSAGE-N-CHEDDAR MORNING ROLL, Smoked Sausage with Cheese Baked in Dough." Each label bears a case code of "5788-SH," as well as the establishment number "EST. 7184M" inside the USDA mark of inspection.
2.25-pound packages of "WHEELER SMOKED SAUSAGE KOLACHES." Each label bears a case code of "8788-W," as well as the establishment number "EST. 7184M" inside the USDA mark of inspection.

Thursday, November 15, 2007

A second suspected outbreak of bird flu is being investigated in UK

A second suspected outbreak of bird flu is being investigated after birds due to be culled in a precautionary measure were found to be already dead.

The dead birds were discovered overnight when animal health officials turned up to kill the farm's 5,500 turkeys.

Grove farm in Botesdale, Suffolk, was one of four sites yesterday assessed by the Department for Environment, Food and Rural Affairs to have been in "dangerous contact" with the initial case of the deadly H5N1 strain of the virus.

War-Related Trauma in Soldiers May Only Surface Months After Returning Home

If Soldiers were screened twice instead of just once after they return from war zones may help to catch more war-related mental health problems, according to an study that is published by the Journal of the American Medical Association.
Soldiers reported more mental health concerns and were referred at significantly higher rates from the PDHRA than from the PDHA. Based on the combined screening, clinicians identified 20.3% of active and 42.4% of reserve component soldiers as requiring mental health treatment. Concerns about interpersonal conflict increased 4-fold. Soldiers frequently reported alcohol concerns, yet very few were referred to alcohol treatment. Most soldiers who used mental health services had not been referred, even though the majority accessed care within 30 days following the screening. Although soldiers were much more likely to report PTSD symptoms on the PDHRA than on the PDHA, 49% to 59% of those who had PTSD symptoms identified on the PDHA improved by the time they took the PDHRA. There was no direct relationship of referral or treatment with symptom improvement.

Rescreening soldiers several months after their return from Iraq identified a large cohort missed on initial screening. The large clinical burden recently reported among veterans presenting to Veterans Affairs facilities seems to exist within months of returning home, highlighting the need to enhance military mental health care during this period. Increased relationship problems underscore shortcomings in services for family members. Reserve component soldiers who had returned to civilian status were referred at higher rates on the PDHRA, which could reflect their concerns about their ongoing health coverage. Lack of confidentiality may deter soldiers with alcohol problems from accessing treatment. In the context of an overburdened system of care, the effectiveness of population mental health screening was difficult to ascertain.
The Study could be found here.

Nike Recalls Football Helmet Chin Straps

FOR IMMEDIATE RELEASE
November 13, 2007
Release #08-081

Firm’s Recall Hotline: (888) 583-6453
CPSC Recall Hotline: (800) 638-2772
CPSC Media Contact: (301) 504-7908

Nike Recalls Football Helmet Chin Straps Which Can Break and Pose Risk of Serious Injury
WASHINGTON, D.C. - The U.S. Consumer Product Safety Commission, in cooperation with the firm named below, today announced a voluntary recall of the following consumer product. Consumers should stop using recalled products immediately unless otherwise instructed.

Name of Product: Football Helmet Chin Straps Units: About 235,000

Manufacturer: Nike Inc., of Beaverton, Ore.

Hazard: The chin strap’s plastic cup can break as a result of contact, exposing the player to facial or head injuries.
I
ncidents/Injuries: Nike has received 18 reports of the chin strap breaking, including two reports of concussions, two reports of facial lacerations requiring stitches, and a report of a broken nose.

Description: The recalled football helmet chin strap consists of a plastic cup with a foam liner, straps and four metal snaps. They were sold in both youth and adult sizes and come in black/gray and white/gray color combinations. The Nike Swoosh trademark is printed on the outside of the chin cup and DRI-FIT™ is printed on the foam liner. “Made in China” and one of the following four style numbers is printed on the inside of the strap: FA0016 046, FA0016 130, FA0021 046, or FA0021 130.

Sold at: Sporting good stores nationwide and on the firm’s Web site www.Nike.com from April 2006 through October 2007 for about $20.

Manufactured in: China

Remedy: Consumers should stop using the chin strap immediately and contact Nike for a product voucher redeemable at www.nikestore.com

Consumer Contact: For additional information, contact Nike toll-free at (888) 583-6453 between 7 a.m. and 4 p.m. PT Monday through Friday, or visit the firm’s Web site at www.nikebiz.com

Wednesday, November 14, 2007

Coffee Masters, Inc., recall all of "Chipper With Coffee Biscotti"

Coffee Masters, Inc. web site did not contain any information about this recall

Contact:
Coffee Masters, Inc.
800.334.6485 Ext. 215

FOR IMMEDIATE RELEASE -- SPRING GROVE, IL – November 13, 2007 – Coffee Masters, Inc., leading Midwest wholesale coffee roaster today announced they have issued a recall all of a Chipper With Coffee Biscotti, because it may contain undeclared protein derived from milk, eggs, tree nuts, peanuts, wheat, and/or soybeans allergens. People who have an allergy or severe sensitivity to any of these allergens run the risk of serious or life-threatening allergic reaction if they consume these products. Coffee Masters distributed this product on behalf of Chipper Gourmet Foods during the months of January – Sept 2007.

Chipper With Coffee Biscotti was distributed wholesale nationwide and could have been found in retail coffee shops. Coffee Masters, Inc. discontinued the distribution in early September, due to lack of sales and interest.

The product comes in a 1.75 ounce clear bag with hang tag. Flavors include Apple Cinnamon, Apricot Almond, Banana Walnut, Chocolate Chip, Chocolate Raspberry, Classic Almond, Mocha Chip, Pistachio Orange, Snickerdoodle, Cranberry Orange, German Chocolate, Maple Pecan, Triple Chocolate and Maple Walnut.

Some of the Biscotti, click to enlarge

No illnesses have been reported to date in connection with this problem.

The recall was initiated after it was discovered that the allergen-containing product was distributed in packaging that did not reveal the presence of the protein derived from milk, eggs, tree nuts, peanuts, wheat, and/or soybeans. Subsequent investigation indicates the problem was caused by a breakdown in Chipper Gourmet Food’s production and packaging processes.

Production of the product has been suspended until FDA and Coffee Masters are certain that the problem has been corrected.

Consumers who have purchased any 1.75 ounce packages of Chipper With Coffee Biscotti distributed by Coffee Masters are urged to return them to the place of purchase for a full refund. Consumers with questions regarding this matter may contact the Coffee Masters at 1-800-334-6485, ext 110.

Del Rey Tortilleria, Inc. Recalls of Flour Tortillas

Contact:
Marcy Toledo
773 637-8900

FOR IMMEDIATE RELEASE -- November 12, 2007 -- Del Rey Tortilleria, Inc., Chicago, Illinois, is announcing the recall of its flour tortilla products.

Included in the recall are flour tortillas of all sizes [White Flour Tortillas; Tortillas de Harina(6 inch); Burritos 2, 3, and 4; and Fajita 8" size] with the name "Del Rey" on the label, and with one of these Date Codes: OCT/17/07; OCT/20/07; OCT/24/07; NOV/04/07; NOV/10/07; or NOV/11/07.

Illinois state officials have told us that they believe there is a connection between the tortillas and recent illnesses in Racine, WI schools, in which students experienced vomiting, nausea and abdominal cramps. If you experience symptoms of this type, you should consult a health professional.

State officials have told us that they do not believe the problem involves microbial contamination. Del Rey is not certain that its products caused the reported symptoms, but is recalling the product nevertheless as a precaution while its investigation continues. This recall does not affect any other Del Rey products.

The products were distributed nationwide through food distributors and grocery stores.

Consumers should immediately return any product that is subject to this recall to the store where it was purchased for a full refund or replacement.

Consumers with questions may contact the company by calling Marcy Toledo, General Manager, at 773 637-8900.

Internet is most trusted source for health information.

Somehow I missed this post about a survey about health care information and how people are using Internet for such information. I will thrive to make MedDesktop one of the best stops for such information.
I have always informed about food, drug and toy recalls in timely manner. The only downside about this site is the advertising I get from AdSense. Sometimes we end up with undesirable ads. But I have taken best care to prevent such ads with filtering provided by Google.
From the post;
"According to Prospectiv's "2007 Pharmaceutical Marketing CPI" poll conducted in June, 75% of 800 consumers surveyed feel the Internet is their most trusted source for health information. And not only was the Internet the most trusted medium, but it was the most reliable place to research ailment and drug information, more so than broadcast media (15%) and magazines (10%). The study also found that online consumers favor general health Web sites (54%) and ailment-focused sites (37%) over pharmaceutical company sites (4%).
"
This is very encouraging for me as that is what the incubating "MedDesktop.com" will focus on, to become the health site!
Google Health Advertising Blog: Trusting the Internet for health

Monday, November 12, 2007

Babies R Us Bassettbaby Baby Cribs Recalled Due to Entrapment and Strangulation Hazard

Name of Product: Wendy Bellissimo Collection Convertible Cribs

Units: About 8,900

Importer: Bassettbaby, of Bassett, Va.

Manufacturer: Goodbaby Child Products Company Ltd., of China

Hazard: The bolts connecting the top corners of the crib can come loose, creating a gap and posing a serious entrapment and strangulation hazard.

Incidents/Injuries: Bassettbaby has 85 reports of bolts loosening, including one report of a 13 month-old child’s hand becoming entrapped between the railings.

Description: This recall involves Wendy Bellissimo Collection convertible cribs, model numbers 5945-0521 and 5545-0521, sold in honey and cherry finishes. The full size cribs have a sleigh design and one of the following purchase order numbers at the bottom rail of the headboard: 272903, 272904, 273904, 276728, 276729, 291081, 323975, 324472, 320318, 323976, 332883 365620, 368466 in honey, and 338535, 338537 and 332884 in cherry. All other Wendy Bellissimo Collection cribs are not involved in this recall.

Sold at: Babies R Us stores nationwide from July 2005 through October 2007 for about $500.

Manufactured in: China

Remedy: Consumers should stop using these cribs immediately and contact Bassettbaby for a free repair kit.

Consumer Contact: For additional information, contact Bassettbaby at (888) 897-4689 between 9 a.m. and 10 p.m. ET daily, or visit the firm’s Web site at www.bassettbaby.com

Sunday, November 11, 2007

Kroger Light Caesar Salad Dressing Recalled

Contact:
Meghan Glynn|
(513) 762-1304

FOR IMMEDIATE RELEASE -- Cincinnati, OH -- November 8, 2007 -- The Kroger Co. today announced a recall of Kroger brand 16 oz. Light Caesar Salad Dressing with a Sell By date of May 09 08, a code of SA7221 and a UPC number: 0 11110-71765 8 on the back label.

The salad dressing is being recalled because the back label of the bottle was mislabeled with a Light Asian Salad Dressing label. A small number of cases were released that contain the back label for light Asian Dressing which does not list milk, egg, and anchovies in the ingredient statement or allergen contains statement. People who have an allergy to milk, eggs, and/or anchovies run the risk of serious or life-threatening reaction if they consume this product.

No illnesses have been reported. For most consumers, there is no safety issue with the salad dressing.

The salad dressing may have been distributed to Kroger, Dillons, Food 4 Less (Chicago area only), Jay C, Smith's, Fry's, King Soopers, and City Market grocery stores. No other Kroger-brand salad dressings are affected by this recall.

The mislabeling issue was identified at three Fry's stores in the Phoenix area. The Company is investigating the mislabeling and will enhance labeling procedures to prevent future occurrences.

Customers are encouraged to return the product to the store they purchased it from for a full refund.

Consumers with questions or concerns may call The Kroger Co. at 1-800-632-6900.

FDA

Circle Foods Recalls Beef Tamales

WASHINGTON, Nov. 8, 2007 - Circle Foods, LLC., a Chula Vista, Calif., establishment, is voluntarily recalling approximately 3,750 pounds of frozen beef tamales that may contain pieces of metal, the U.S. Department of Agriculture's Food Safety and Inspection Service announced today.

The following products are subject to recall: [View Label | PDF]

Cartons of 10 individually wrapped 5-ounce tamales "Tortilla land BEEF TAMALES, Traditional Corn Husk Wrap, All Natural."

Each carton also bears the establishment number "EST. 17417" inside the USDA mark of inspection as well as a "use by" date of "110308."

The products were produced on Nov. 3, and were distributed to Costco stores in the Los Angeles, Calif., area.

The problem was discovered by the company after their equipment detected pieces of metal in the product that is subject to recall. No injuries have been reported at this time. Anyone concerned about an injury from consumption of the products should contact a physician.

Consumers with questions about the recall should contact Quality Assurance Director Omar Houry at (619) 507-3379. Media with questions about the recall should contact Vice President of Operations Eric Brenk at (619) 263-8000.

Consumers with food safety questions can "Ask Karen," the FSIS virtual representative available 24 hours a day at AskKaren.gov. The toll-free USDA Meat and Poultry Hotline 1-888-MPHotline (1-888-674-6854) is available in English and Spanish and can be reached from l0 a.m. to 4 p.m. (Eastern Time) Monday through Friday. Recorded food safety messages are available 24 hours a day.

Health Net Sued for rescinding and for giving bonuses for policy rescissions

From San Francisco Chronicle:

Health Net Inc., one of the California's largest health insurers, tied rewards and savings to its employees' ability to cancel policies based on misrepresentations in members' applications, according to documents in a lawsuit against the company.

The documents showed Health Net saved $35.5 million in "unnecessary" health care expenses for rescinding more than 1,000 policies between 2000 and 2006. At the same time, a Health Net analyst received about $21,000 in bonuses for her work, which included exceeding company goals for policy rescissions.

Insurers say the practice is legal and necessary because it protects them against fraud, and keeps premiums lower for those members who truthfully reveal their health history. But state regulators and plaintiffs' lawyers have argued that the applications often are vague and confusing, and that it's not fair for insurers to review applications only after members file an expensive claim.

In Bates' case, her lawyers contend that Health Net tied an employee's bonus to her ability to review cases and rescind coverage. State law prohibits insurance companies from offering financial incentives to reduce or deny care.

According to the documents, Health Net analyst Barbara Fowler, who conducted Bates' investigation, exceeded the company's 2002 goal of 15 rescissions a month by averaging 22.9. Fowler's rescission successes were repeatedly lauded in her performance evaluations, which noted she saved the company $5.5 million in 2002 for rescinding 275 contracts. Her bonuses ranged from $1,654 in 2001 to a high of $6,310 in 2005.

Well check what you are filling, very carefully those insurance forms. Insurance firms are here to make money, not to save or aid you.

Link to SF Chronicle

Biologist Fall Prey to Plague

PHOENIX - A wildlife biologist at Grand Canyon National Park likely died from the plague through his exposure to wild animals that can carry the disease, the National Park Service said Friday.

Eric York, 37, was found dead in his home Nov. 2. Following his death, about 30 people who came in contact with him were given antibiotics as a precaution. While authorities were uncertain about how York became infected, officials said that the biologist was at a greater risk to the sometimes fatal disease through his exposure to wild rodents and mountain lions. Park Service officials initially said they suspected the plague or hantavirus, another sometimes-fatal disease endemic to the Southwest, because of York's interests and hobbies.

Yahoo News

Biologist Fall Prey to Plague

Dizzy Ducks Music Box Recalled Due To Violation of Lead Paint Standard

WASHINGTON, D.C. - The U.S. Consumer Product Safety Commission, in cooperation with the firm named below, today announced a voluntary recall of the following consumer products. Consumers should stop using recalled products immediately unless otherwise instructed.

Name of Product: Dizzy Ducks Music Box

Units: About 1,300

Importer: Schylling Associates Inc., of Rowley, Mass.

Hazard: Surface paints on the wooden base of the music box contain excessive levels of lead, which violates the federal lead paint standard.

Incidents/Injuries: None reported.

Description: The Dizzy Ducks Music Box is a wind-up music box with ducks that spin as music plays.

Sold at: Specialty toy stores and gift shops nationwide from March 2007 through October 2007 for about $12.

Manufactured in: China

Remedy: Consumers should immediately take the recalled toy away from children and contact Schylling to receive a refund or free replacement toy.

Consumer Contact: For additional information, contact Schylling at (800) 767-8697 between 9 a.m. and 5 p.m. ET Monday through Friday, or visit the firm’s Web site at www.schylling.com

Marvel Toys' Curious George Toy's Recalled Due to Lead Paint Contamination

Hat and Face has Lead Paint

This recall involves Curious George 12-inch plush dolls with a plastic face. The dolls are dressed to represent five various themes: birthday, fireman, sweet dreams, tool time and tool time with a soft face. The plush dolls were sold with a Curious George storybook or activity book. The following product and SKU numbers are printed on the packaging. (See below for more images)
Birthday 90253/ 8-83199-90253-5
Fireman 90246/ 8-83199-90246-7
Sweet Dreams 90247/ 8-83199-90247-4
Tool Time 90251/ 8-83199-90251-1
Tool Time (soft face) 90251/ 8-83199-90251-1

Sold at: Toy and discount department stores nationwide from December 2005 through August 2007 for about $15.

Manufactured in: China

Remedy: Consumers should immediately take the recalled toys away from children and contact Marvel Toys to receive a full refund.

Consumer Contact: For additional information, contact Marvel Toys at (800) 352-2064 between 7 a.m. and 6 p.m. CT Monday through Friday, or visit the firm’s Web site at www.regcen.com/curiousgeorge

Sweet Dreams

Birthday

Fireman

Tool Time (soft face)

Children's sunglasses recalled Due to Lead Contamination

U.S. Consumer Product Safety Commission informs us about the recall that involves 51,000 yellow children's sunglasses distributed by Dolgencorp Inc., of Goodlettsville, Tenn. The yellow sunglasses have the word "China" printed on the left side of the frame.
The UPC #400007860896 and words "Fashion Sunglasses" and "Time to Play Every Day" are printed on the product's red hangtag. T
he glasses were sold at Dollar General stores across the United States from March 2005 through October 2007 for $1.
Remedy: Consumers should take the recalled sunglasses away from young children immediately and return them to any Dollar General store for a full refund.
Consumer Contact: For additional information, contact Dollar General at (800) 678-9258 between 9 a.m. and 6 p.m. ET Monday through Friday, or visit the firm's Web site at www.dollargeneral.com

FDA's Risk Communication Advisory Committee

The U.S. Food and Drug Administration has selected 15 voting members to serve on its Risk Communication Advisory Committee. The Committee will advise FDA about how best to communicate to the public about the risks and benefits of FDA-regulated products so as to facilitate their optimal use.

On June 5, 2007 FDA announced the establishment of the advisory committee and requested nominations for qualified individuals to serve as members. The agency received more than 240 nominations, many for exceptionally qualified individuals.

The establishment of the advisory committee was one of the recommendations of the Institute of Medicine’s 2006 report, "The Future of Drug Safety: Promoting and Protecting the Health of the Public."

"Communicating effectively about the safety and effectiveness of drugs and other medical products is one of the central roles of FDA," said Randall Lutter, Ph.D., Deputy Commissioner for Policy. "We were in such strong agreement about the value of the Risk Communication Advisory Committee that we expanded its scope to address communication regarding all products regulated by the agency, including our food supply responsibilities."

The advisory committee’s 15 voting members include independent experts and public members. Experts were chosen from the fields of risk communication, risk perception, decision analysis, communication, social marketing, health literacy, journalism, and other behavioral and social sciences. Public members include those who can provide the perspective of users of FDA-regulated products, such as consumers, patients, caregivers and health care providers. For some meetings, one or more industry representatives may be invited to participate in a nonvoting capacity.

Members have been assigned to serve for periods ranging from one to four years. FDA expects to hold the committee’s first meeting in the first quarter of 2008. The list of members is available on FDA’s Web site at http://www.fda.gov/oc/advisory/OCRCACRoster.htm.

FDA is currently amending the committee’s charter to incorporate the provisions of the recently passed Food and Drug Administration Amendments Act of 2007.

FDA approvesZyrtec-D an allergy drug for nonprescription use

The Food and Drug Administration (FDA) has approved Zyrtec-D (cetirizine HCl 5 mg and pseudoephedrine HCl 120 mg), an allergy drug, for nonprescription use in adults and children 12 years of age and older. This drug combines an antihistamine with a nasal decongestant.

Available as a prescription drug since 2001, Zyrtec-D is now approved as a nonprescription drug for the relief of symptoms due to hay fever or other upper respiratory allergies such as, runny nose, sneezing, itchy, watery eyes, itching of the nose or throat, and nasal congestion. Zyrtec-D is also for reducing swelling of nasal passages, for relief of sinus congestion and pressure, and for restoring freer breathing through the nose.

Hay fever and other allergies are the sixth leading cause of chronic disease, with about 50 million sufferers each year in the United States, according to the National Institute of Allergy and Infectious Diseases.

"The approval of this widely-used drug for nonprescription use will enable many people to have access to another effective treatment for their allergy symptoms," said Andrea Leonard-Segal, M.D., director, Division of Nonprescription Clinical Evaluation in the FDA"s Center for Drug Evaluation and Research. "This approval reflects FDA's commitment to bringing prescription drugs to the over-the-counter market when they can be safely used without a prescription.

Zyrtec-D"s common side effects include drowsiness, fatigue, and dry mouth. Sales of the drug are subject to restrictions in the Combat Methamphetamine Epidemic Act. This law places restrictions on the sale of products containing pseudoephedrine, such as limiting the amount that an individual can purchase, and imposing record keeping requirements on the retail establishments that sell the product. Zyrtec-D is distributed by McNeil Consumer Healthcare, Fort Washington, Pa.

For more information:

Allergies and Hay Fever Fact Sheet
www.fda.gov/womens/getthefacts/allergies.html

Friday, November 09, 2007

Merck Will Settle the Vioxx Cases with $4.85 Billion

Merck & Co. is expected to announce Friday that it will settle all claims relating to its withdrawn Vioxx pain killer for about $4.85 billion, according to a media report. The announcement is expected in New Orleans, The WSJ reported in its online edition, citing an unnamed person familiar with the situation. The company faces roughly 27,000 suits. Merck withdrew the drug in 2004 following revelations it was found to cause heart problems and other serious side effects. The once-popular drug had peak sales of $2.5 billion before the health troubles emerged.
The Journal reported that the decision to settle was surprising given Merck's victories in four out of five of the important cases.
Source Marketwatch

Thursday, November 08, 2007

VOIP IP Telephony: Deaf, Hard-of-Hearing, or Speech Impaired can Make realtime Voice Calls with SnapVRS.

Communication medium for Deaf, Hard of hearing and Speech impaired people. I think this is a great Service.
VOIP IP Telephony: Deaf, Hard-of-Hearing, or Speech Impaired can Make realtime Voice Calls with SnapVRS.

Wednesday, November 07, 2007

Toy Cars Recalled by Dollar General

Name of Product: Pull-Back Action Toy Cars

Units: About 380,000

Importer: Dollar General Merchandising Inc., of Goodlettsville, Tenn.

Hazard: Surface paint on the cars contains excessive levels of lead, violating the federal lead paint standard.

Incidents/Injuries: None reported.

Description: The recall involves two styles of “pull and release” toy cars, including a four pack of Super Wheels (UPC #400016576344) and a two pack of Super Racer cars (UPC # 883788965002).

Sold at: Dollar General stores nationwide from April 2007 through October 2007 for about $1 per pack.

Manufactured in: China

Remedy: Consumers should immediately take the recalled toy cars away from children and return them to any Dollar General store for a full refund.

Consumer Contact: For additional information, contact Dollar General at (800) 678-9258 between 9 a.m. and 6 p.m. ET Monday through Friday, or visit the firm’s Web site at www.dollargeneral.com

Aqua Dots Recalled by Spin Master

Children Became Unconscious After Swallowing Beads

Name of Product: Aqua Dots (The toy sold in Canada is also called Aqua Dots and is similar to a product sold in Australia called Bindeez.)

Units: About 4.2 million

Distributor: Spin Master, of Toronto, Canada

Hazard: The coating on the beads that causes the beads to stick to each other when water is added contains a chemical that can turn toxic when many are ingested. Children who swallow the beads can become comatose, develop respiratory depression, or have seizures.

Incidents/Injuries: CPSC has received two reports over the past several days of children swallowing Aqua Dots. A 20-month-old child swallowed several dozen beads. He became dizzy and vomited several times before slipping into a comatose state for a period of time, was hospitalized, and has since fully recovered. A second child also vomited and slipped into a comatose state and was hospitalized for five days.

Description: The recalled toy is a craft kit which allows children to create various multi-dimensional designs using small colored beads. The beads fuse together when sprayed with water. The recall applies to all models of Aqua Dots. The product is available in various different kits with accessories such as a drying fan, applicator pen, design templates for the beads, and spray bottle. The product is labeled for ages 4+.

Sold at: Mass merchandisers nationwide from April 2007 through November 2007 for between $17 and $30.

Manufactured in: China

Remedy: Consumers should immediately take the recalled toy away from children and contact Spin Master to return for free replacement beads or a toy of equal value.

Consumer Contact: For additional information, contact Spin Master at (800) 622-8339 between 9 a.m. and 6 p.m. ET Monday through Friday, or visit the firm’s Web site at www.aquadotsrecall.com(site under construction)

Firm’s Recall Hotline: (800) 622-8339
CPSC Recall Hotline: (800) 638-2772
CPSC Media Contact: (301) 504-7908

Tuesday, November 06, 2007

Vermont is the best State For Your Health thi Year

America’s Health Rankings ™ – 2007 Edition shows Vermont at the top of the list of healthiest states. This is the first year Vermont has been ranked number one. The state has had a steady climb in the rankings for the last seven years from an initial position of eighth in 2001. Minnesota is ranked second this year; it was first in the 2006 Edition. Minnesota has been first for the last four years and for 11 of the 18 Editions of this report. Hawaii is number three, followed by New Hampshire, Connecticut and Utah. Mississippi is 50^th and the least healthy state, while Louisiana is 49^th. Arkansas, Oklahoma and Tennessee complete the bottom five states. California, my Sunny State is 25th!, Why?

Vermont moved from 16^th in 1990 to its current lead position. Vermont’s strengths include ranking in the top five states for a low rate of preventable hospitalizations, ready access to adequate prenatal care, a low percentage of children in poverty, ready access to primary care and a low prevalence of obesity. It also ranks first overall for its strengths in all health determinants combined and ranks in the top 20 states for all measures except two. Those two challenges are low per capita public health spending (ranked 41^st) and a high prevalence of binge drinking at 16.7 percent of the population. See Vermont’s state snapshot here.

Get more information here

Marketing Suspension of Trasylol Requested By FDA

The U.S. Food and Drug Administration (FDA) today announced that, at the agency's request, Bayer Pharmaceuticals Corp. has agreed to a marketing suspension of Trasylol, a drug used to control bleeding during heart surgery, pending detailed review of preliminary results from a Canadian study that suggested an increased risk for death.

FDA requested the suspension in the interest of patient safety based on the serious nature of the outcomes suggested in the preliminary data. FDA has not yet received full study data but expects to act quickly with Bayer, the study's researchers at the Ottawa Health Research Institute, and other regulatory agencies to undertake a thorough analysis of data to better understand the risks and benefits of Trasylol.

There are not many treatment options for patients at risk for excessive bleeding during cardiac surgery. Thus, FDA is working with Bayer to phase Trasylol out of the marketplace in a way that does not cause shortages of other drugs used for this purpose.

Until FDA can review the data from the terminated study it is not possible to determine and identify a population of patients undergoing cardiac surgery for which the benefits of Trasylol outweigh the risks. Understanding that individual doctors may identify specific cases where benefit outweighs risk, FDA is committed to exploring ways for those doctors to have continued, limited access to Trasylol.

Two weeks ago, FDA was notified that researchers with the Ottawa Health Institute stopped a study on Trasylol because the drug appeared to increase the risk for death compared to two other antifibrinolytic drugs used in the study. Antifibrinolytic drugs help slow the breakdown of blood clots and subsequent excessive bleeding. The preliminary data from this terminated study also suggested that fewer patients receiving the drug experienced serious bleeding events.

On Oct. 26, FDA issued an Early Communication about an Ongoing Safety Review of Trasylol in response to the Canadian study's termination. In 2006, FDA revised the labeling for Trasylol to strengthen its safety warning and limit its approved usage to patients at an increased risk for blood loss and blood transfusion during coronary bypass graft surgery.

FDA

Another Mattel Toy Recall, Laugh & Learn™ Learning Kitchen™ Toys

CPSC, The U.S. Consumer Product Safety Commission has released the following News release;

FOR IMMEDIATE RELEASE
November 6, 2007
Release #08-063

Firm’s Recall Hotline: (888) 812-7187
CPSC Recall Hotline: (800) 638-2772
CPSC Media Contact: (301) 504-7908

Laugh & Learn™ Kitchen Toys Recalled by Fisher-Price Due To Choking Hazard

Name of Product: Laugh & Learn™ Learning Kitchen™ Toys

Units: About 155,000

Importer: Fisher-Price Inc., of East Aurora, N.Y.

Hazard: Pieces of the faucet or the clock hands can detach, posing a choking hazard to young children.

Incidents/Injuries: There have been 48 reports of small parts separating from the toys, including two reports of children gagging on pieces, one report of a child who started choking on a piece and one report of a child who choked on a piece.

Description: The recall involves a play kitchen learning toy with a pretend refrigerator, range and sink. The product’s item number L5067 is stamped in several locations on the toy and printed on the product’s packaging above the UPC.

Sold at: Various retail and toy specialty stores nationwide from May 2007 through October 2007 for about $70.

Manufactured in: Mexico

Remedy: Consumers should immediately take the recalled toys away from children and contact Fisher-Price for a free repair kit.

Consumer Contact: For additional information, contact Fisher-Price toll-free at (888) 812-7187 between 9 a.m. and 7 p.m. ET Monday through Friday and between 11 a.m. and 5 p.m. ET Saturday, or visit the firm’s Web site at www.service.mattel.com

Limited Too Stores Girl's Gift Set Recall

FOR IMMEDIATE RELEASE
November 1, 2007
Release #08-058

Firm’s Recall Hotline: (800) 934-4497
CPSC Recall Hotline: (800) 638-2772
CPSC Media Contact: (301) 504-7908

Pearl-like Bead Attachment Sold with Girl’s Gift Sets Recalled Due to Violation of Lead Paint Standard; Sold exclusively at Limited Too Stores

Name of Product: Decorative Packaging Pearl-like Bead Attachments sold with Girl’s Gift Sets

Units: About 4,000

Distributor: Tween Brands Inc., of New Albany, Ohio

Hazard: Surface coating on a plastic bead decorative packaging attachment contains excessive levels of lead, violating the federal lead paint standard.

Incidents/Injuries: None reported.

Description: The recalled item is a pearl-like pink bead attachment on the outside packaging of the gift sets and a zipper pull/wrist band on a cosmetic lip gloss set. The gift sets were sold under the “Sparkle by Too” line, as follows: 3-Pack Lip Gloss Wristlet (Style No. 2014), 4-Pack Body Spray (Style No. 2017), and 3-Piece Bath Set (Style No. 2018).

Sold at: Limited Too retail stores nationwide, catalog and Web site from April 2007 through September 2007 for between $11 and $13.

Manufactured in: China

Remedy: Consumers should immediately remove this recalled decorative pearl-like bead attachment from the gift sets and return it to any Limited Too store for a $5 Limited Too coupon. In addition to the $5 coupon, consumers who choose to return the gift sets along with the packaging attachment will receive a full refund.

Consumer Contact: For additional information, call Tween Brands at (800) 934-4497 between 9 a.m. and 5 p.m. ET Monday through Friday, or visit the firm’s Web site at www.limitedtoo.com

Saturday, November 03, 2007

Cargill Recalls Ground Beef

Action due to possible E. coli O157:H7 contamination

FOR IMMEDIATE RELEASE: Oct. 6, 2007

Contact: Lori Fligge 952-742-2275, lori_fligge@cargill.com

WICHITA, Kan. – Cargill Meat Solutions said it is voluntarily recalling approximately 1,084,384 pounds of ground beef produced at its Wyalusing, Pa., Cargill Regional Beef facility because of the possible presence of E. coli O157:H7. The ground beef products subject to recall were produced at the Wyalusing plant between Oct. 8 and 11, 2007, and were distributed to retailers nationwide.

Cargill learned of the possibility of contamination after the U.S. Department of Agriculture returned a confirmed positive on a sample of product produced Oct. 8, 2007.

“No illnesses have been associated with this product,” said John Keating, president, Cargill Regional Beef. “We are working closely with the USDA to remove the product from the marketplace.”

Each package or label bears the establishment number “Est. 9400” inside the USDA mark of inspection. As the use/freeze-by dates for products subject to this recall have expired, consumers are urged to look in their freezers for these products and return or discard them if found.

In addition to the above listed products, there are various weights and varieties of ground beef, ground chuck, and ground sirloin product that were distributed for further processing and repackaging and will not bear the same establishment number on the package.

Consumers with questions about the recall should contact the company’s food safety line at 1-877-455-1034. Media with questions should contact the company’s media representative, Lori Fligge, at 952-742-2275.

E. coli O157:H7 is a potentially deadly bacterium that can cause bloody diarrhea and dehydration. The very young, seniors and persons with compromised immune systems are the most susceptible to foodborne illness. Food safety experts recommend cooking any ground beef to an internal temperature of 160 degrees F., or until the meat is no longer pink and the juices run clear. Also, avoid contaminating other foods with any E. coli bacteria that may be present in meat by:

Washing hands, utensils and cutting boards after they have been in contact with raw meat before they touch other food.
Putting cooked meat on a clean platter, rather than on the other one that was used to hold raw meat.

Consumers with food safety questions also can “Ask Karen,” the FSIS virtual representative available 24 hours a day at ASKKaren.gov. The toll-free USDA Meat and Poultry Hotline 1-888-MPHotline (1-888-674-6854) is available in English and Spanish and can be reached from 10 a.m to 4 p.m. (Eastern Time) Monday through Friday. Recorded food safety messages are available 24 hours a day.

Washing hands, utensils and cutting boards after they have been in contact with raw meat before they touch other food.
Putting cooked meat on a clean platter, rather than on the other one that was used to hold raw meat.

NOTE: FSIS’ Web site has the list of products recalled as well. There is also a PDF with images of the products recalled.

FDA Requests Recall of 'True Man Sexual Energy,' 'Energy Max'

The U.S. Food and Drug Administration yesterday requested a recall of True Man Sexual Energy Nutrient Capsules and Energy Max Energy Supplement Men's Formula Capsules, illegal drug products that contain potentially harmful, undeclared ingredients. The products, often advertised as ``all natural'' alternatives to approved erectile dysfunction drugs, could interact with medications and cause dangerously low blood pressure. They contain substances that have similar structures to active ingredients in approved prescription drugs.

The FDA has not approved True Man or Energy Max, and their safety and effectiveness are unknown.

The FDA requested the recall of all products distributed under both labels in a letter to Yin Kao, president and owner of America True Man Health Inc., of West Covina, Calif.

The products are often advertised in newspapers, retail stores, and on the Internet.

“The risk is even more serious because consumers may not know that these ingredients can interact with medications and dangerously lower their blood pressure," said Janet Woodcock, M.D., deputy commissioner for scientific and medical programs, chief medical officer and acting director of the FDA’s Center for Drug Evaluation and Research.

As formulated, True Man Sexual Energy and Energy Max are classified as unapproved new drugs that do not declare the active ingredients thione, an analog of sildenafil; or piperadino vardenafil, an analog of vardenafil. Analogs may cause side effects and drug interactions similar to the approved drugs they resemble.

The undeclared ingredients may interact with nitrates found in some prescription drugs such as nitroglycerin. Men with diabetes, high blood pressure, high cholesterol or heart disease often take nitrates.

The FDA issued an alert on May 10, 2007, (http://www.fda.gov/bbs/topics/NEWS/2007/NEW01633.html) advising consumers not to buy or use True Man or Energy Max products. Today’s recall request comes as a result of the company previously failing to notify all of their consignees and involves True Man Sexual Energy packaged in blister pack cartons of 10 capsules and Energy Max packaged in blister pack cartons of 20 capsules. FDA is prepared to take further regulatory action should the firm refuse to accede to this request.

FDA chemical analysis has shown that Energy Max contains thione, an analog of sildenafil, a substance similar to the active ingredient in the approved ED drug Viagra. In addition, FDA investigators found that True Man contains the same analog or an analog of vardenafil, the active ingredient Levitra, another approved ED treatment. Neither of the analogs used in True Man or Energy Max are components of FDA-approved drug products.

Customers who have either product in their possession should stop using it immediately and contact their health care provider if they have experienced any problems that may be related to taking this product.

Consumers should report adverse events related to these products to MedWatch, the FDA's voluntary reporting program:

www.fda.gov/medwatch/report.htm

Friday, November 02, 2007

General Mills Recalls Totino’s & Jeno’s Frozen Pizzas With Product and contact information

General Mills has recalled Five million Totino's and Jeno's frozen pepperoni pizzas that could be linked to an outbreak of E. coli O157:H7 in the United States. The pizzas were made in the company's Wellston, Ohio plant and distributed across the United States.

Between July 20 and Oct. 10, there were 21 cases ofE. Coli0157:H7 reported in Illinois, Kentucky, Missouri, New York, Ohio, Pennsylvania, South Dakota, Tennessee, Virginia and Wisconsin. Of the 21 people who became ill, nine said they'd eaten Totino's or Jeno's pizza with pepperoni, the U.S. Department of Agriculture's Food Safety and Inspection Service said in a news release.

Included in the recall are Totino's Original Crisp Crust Party Pizza and Jeno's Crisp 'N Tasty Pizza containing pepperoni or a combination of pepperoni, sausage and other ingredients, theAPreported. Packages affected by the recall show "EST. 7750" inside the USDA mark of inspection, and include a "best if used by" date on or before "02 APR 08 WS."

The specific products in the recall include:

Brand	Product	SKU number
Totino's	Party Supreme	42800-10700
Totino's	Three Meat	42800-10800
Totino's	Pepperoni	42800-11400
Totino's	Pepperoni	42800-92114
Totino's	Classic Pepperoni	42800-11402
Totino's	Pepperoni Trio	42800-72157
Totino's	Party Combo	42800-11600
Totino's	Combo	42800-92116

Jeno's	Crisp 'n Tasty Supreme	35300-00561
Jeno's	Crisp 'n Tasty Pepperoni	35300-00572
Jeno's	Crisp 'n Tasty Combo	35300-00576

Any consumers concerned about an illness should contact a physician. Anyone diagnosed by a physician as having an illness related to E. coli O157:H7 is also urged to contact state and local public health authorities.

Consumers can contact Totino’s / Jeno’s for product replacement by clipping the UPC (bar code) symbol from each pizza box and sending their UPC's, along with their name and address to:

Totino's / Jeno’s
P.O. Box 200 - Pizza
Minneapolis, MN 55440-0200

The product itself should be thrown away. Consumers with additional questions about the recall should contact the company at (800) 949-9055.

Thursday, November 01, 2007

Congress Passes Child HealthCare Bill, Again

WASHINGTON (AP) — A defiant Democratic-controlled Congress voted Thursday to provide health insurance to an additional 4 million lower-income children, and President Bush vowed swiftly to cast his second straight veto on the issue.

The legislation cleared the Senate on a vote of 64-30. It passed the House last week, but supporters were shy of the two-thirds majority needed to override Bush's threatened veto.

"We're convinced that the president has undermined an effort to protect children," Senate Majority Leader Harry Reid, D-Nev., said shortly before the vote.

"Congress has known for weeks that the President would veto this bill," White House press secretary Dana Perino countered in a statement shortly after the vote. "Now Congress should get back to work on legislation that covers poor children and stop using valuable floor time to make partisan statements."

In a situation of unusual political complexity, Republicans dictated the decision to pass the legislation speedily. It appeared their goal was to short-circuit attempts by supporters of the bill to reach a compromise that could attract enough votes in the House to override Bush's veto.

Attempts by Reid to delay final passage of the bill until next week or longer drew objections from the GOP.

"I believe a deal is within reach," said Sen. Max Baucus, D-Mont., the chairman of the Senate Finance Committee, a participant in meetings with two senior Senate Republicans, Sens. Charles Grassley of Iowa and Orrin Hatch of Utah, and several members of the House GOP.

Rep. Judy Biggert, R-Ill., who supported Bush's first veto and is involved in the discussions, said "we are pretty close" to an agreement but that several issues remain. For example, she said, the two sides had narrowed their differences on the issue of insuring maximum coverage of poor children before those in slightly higher-income families can be brought into the program.

Baucus said the negotiations would resume next week.

The veto-threatened measure would add an estimated 4 million beneficiaries to an existing program that provides coverage for children from families who earn too much to qualify for Medicaid but cannot afford private insurance. The program currently provides benefits to roughly 6 million children.

At a cost of $35 billion, the bill would be paid for through an increase in tobacco taxes, including a 61-cent rise on a package of cigarettes.

Bush vetoed an earlier children's health bill this fall, and Republican critics said it failed to give a high enough priority to covering poor children, marked a Democratic attempt to expand government-run health care, and did not take sufficient steps to prevent the children of illegal immigrants from receiving benefits.

Democrats failed to override his veto on a vote of 273-156, 13 short of the two-thirds majority they needed.

In response, Democrats launched a replacement measure, incorporating changes they said were designed to meet Republican objections to their first offering.

But Bush dismissed those efforts this week, telling a business audience, "If Congress sends this bill back to me, I'm going to veto it again." He predicted his second veto would be upheld.

A day earlier, the president told House Republicans in a private meeting that he would veto any measure that raised tobacco or any other taxes, a significant hardening of the administration's public position on the issue.

Political polls show the children's health issue enjoys widespread support, and Democrats and their allies have moved quickly to exploit it for their advantage with television and radio commercials attacking Republicans who opposed the legislation.

The result has been a growing nervousness among House Republicans looking ahead to the 2008 elections. The party's top leaders, Reps. John Boehner of Ohio and Roy Blunt of Missouri, joined the compromise negotiations in recent days.

It is unlikely either of them would support a bill that raises taxes. Rather, officials said their intention was to coax as many concessions as possible from the Democrats so that the next measure would be one that other Republicans among the rank-and-file could comfortably support.

As an example of the unusual political maneuvering on the legislation, House Majority Leader Steny Hoyer announced shortly after the vote that Democrats would not immediately send the measure to the White House.

And Reid said that out of deference to rank-and-file House Republicans who are involved in the talks, he would ask Speaker Nancy Pelosi not to call for an immediate attempt to override a veto.

Whether it succeeded or not, such a vote would only add to the political discomfort of GOP lawmakers who have supported the president so far on the issue, but may eventually part company with him.

As part of the negotiations, House Republicans presented a proposal several days ago that requires a 90-percent signup rate for the poorest eligible children before a state can expand coverage.

According to a description of the proposal made available to The Associated Press, no adults could be covered beginning Oct. 1, 2008, except for pregnant women, although any adults currently receiving benefits could be transferred to Medicaid.

All applicants would be required to stipulate that family assets did not exceed $1 million. Anyone seeking coverage would have to provide a birth certificate as proof of citizenship, a provision designed to bar illegal immigrants from receiving benefits.

The proposal from House Republicans made no mention of the tobacco tax increase.

The legislation that passed the Senate drew the support of 45 Democrats, 17 Republicans and two independents. All 30 votes in opposition were cast by Republicans.

Associated Press writer Charles Babington contributed to this story.

The WCRF/AICR Expert Report, Food, Nutrition, Physical Activity and the Prevention of Cancer: a Global Perspective.

An international team of experts, has issued a set of guidelines to help people everywhere reduce their risk of cancer. The recommendations focus on weight loss, exercise, and a diet that limits foods known to increase the risk of cancer.
Although seemingly repeating what we already know, this team has spent years reviewing thousands of scientific studies and has formulated the lengthy report, which all the major new reporting sites tend not to direct you, Why? Perhaps to keep the users from leaving.
The report is 500 odd pages long and has vast amount of information. If you are interested in your health, not just preventing cancer.
The study recommends that that people should be as lean as possible without getting underweight. In real world, that amount to body mass index at the low end of the normal range. For example, if you're 1.7 (5.6 feet)meters tall you might aim for about 55 kilos(121 pounds), for a body mass index of 19. You can lear more about Body Mass Index, BMI here.

The report recommends a mostly-vegetarian diet with only 500 grams of red meat per week, and avoiding processed meat as much as possible. One must also limit the amounts of energy-dense foods that are made with lots of fats and sugar. It also suggests limiting salt to about six grams a day and having no more than one drink of alcohol a day for women, two drinks at most for men.
The report also recommends breastfeeding. Mother's milk is the perfect food for a newborn, of course, but panel member Walter Willett of Harvard University says research indicates it can also help prevent cancer in the mother. "Our report found convincingly that mothers who breastfeed reduce their own chances of developing pre- and post-menopausal breast cancer. This benefit of breastfeeding is probably related to hormonal factors," he said
So the report basically asks us to be responsible human beings, responsible to our-selves.
The repeort could be viewed, down loaded at dietandcancerreport.org where you can also find the most up to date reference and resource material regarding the report.

Cat DNA deciphered!

The first "rough draft" genome for the domestic cat has been sequenced by an international team of scientists. The new sequence is based on the DNA of a four-year-old Abyssinian named Cinnamon, a purebred cat whose lineage can be traced for several generations.
The female animal yielded about 65 percent of the cat genome, which is now thought to contain 20,285 genes. By contrast, the human genome is believed to hold between 20,000 and 25,000 genes.
"[Cinnamon] 'volunteered' to have her genome sequenced so that we could understand [more about] the details of what makes a cat a cat," said study co-author Stephen O'Brien of the National Cancer Institute's Laboratory of Genomic Diversity in Frederick, Maryland.
You can get more information here.

Thursday, November 29, 2007

30-day extension to run through Dec. 26, 2007

Wednesday, November 28, 2007

Tuesday, November 27, 2007

Tips for Proper Use

For More Information

Monday, November 26, 2007

Sunday, November 25, 2007

Saturday, November 24, 2007

Friday, November 23, 2007

Harry & David recalls Harry and David Moose Munch® Confection Tubs in Two Flavor Combinations: Milk & Dark Chocolate, White Chocolate Macadamia and Peanut Butter, Milk Chocolate, Macadamia Nut for Undeclared Nut Allergen

Sweetwater Valley Farms, Inc. Recalls Southern Cheddar Jack Volunteer Special Cheese

Le Gourmet Connection Recalls Jack Cheese

FDA Issues Early Communication for Chantix

FDA Approves Zyrtec for Nonprescription Use in Adults and Children

Thursday, November 22, 2007

Flashing Pacifiers Recalled By Sailing (U.S.) International Corp. Due to Choking Hazard

Children’s Pencil Pouches Recalled by Raymond Geddes & Co. Due to Violation of Lead Paint Standard

Children's Metal Jewelry Recalled by Buy-Rite Due to Risk of Lead Exposure

Cherrydale Fundraising Recalls Bracelets Due to Risk of Lead Exposure

Children’s Metal Jewelry Recalled by Colossal Jewelry & Accessories Due to Risk of Lead Exposure

La Femme NY Inc. Recalls Children’s Necklace and Earring Sets Due to Risk of Lead Exposure

Pure Allure Recalls Metal Jewelry Sold at Michaels Stores Due to Risk of Lead Exposure to Children

Discount School Supply Recalls Paint Brushes Due to Violation of Lead Paint Standard

Metal Jewelry Sold by Family Dollar Stores Recalled Due to Risk of Lead Exposure to Children

Children's Snow and Sand Castle Kits by Paricon Recalled Due to Sharp Edges; Sold Exclusively at LL Bean

Wednesday, November 21, 2007

Tuesday, November 20, 2007

Monday, November 19, 2007

Sunday, November 18, 2007

Saturday, November 17, 2007

Friday, November 16, 2007

New York

Oregon

Washington

Texas

Editorial Note:

Bon-Ton Recalls Children’s Bath Robes Due to Burn Hazard

Thursday, November 15, 2007

Wednesday, November 14, 2007

Monday, November 12, 2007

Sunday, November 11, 2007

Friday, November 09, 2007

Thursday, November 08, 2007

Wednesday, November 07, 2007

Children Became Unconscious After Swallowing Beads

Tuesday, November 06, 2007

Laugh & Learn™ Kitchen Toys Recalled by Fisher-Price Due To Choking Hazard

Pearl-like Bead Attachment Sold with Girl’s Gift Sets Recalled Due to Violation of Lead Paint Standard; Sold exclusively at Limited Too Stores

Saturday, November 03, 2007

Friday, November 02, 2007

Thursday, November 01, 2007

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