/* mobile /* end mobile 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] Adobe Acrobat pdf format
[October 2007 - Label - Novartis] Adobe Acrobat pdf format

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

bullet 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.
bullet 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.
bullet 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.
bullet 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.
bullet 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.
bullet “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.
bullet 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.
bullet 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

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.

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 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

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: 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

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: 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

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: 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

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: 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

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: 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.

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