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Are Your Vitamins Safe?

Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts

Monday, December 29, 2008

Tainted Weight Loss Pills, are you taking any of these?

Tainted Weight Loss Pills Flagged as Health Risks

On Dec. 22, 2008, the Food and Drug Administration (FDA) alerted consumers not to buy or use more than 25 different weight-loss pill products because the products may be harmful to their health.

Which products were cited?

The tainted weight-loss products specified in the alert are:

  • Fatloss Slimming
  • 2 Day Diet
  • 3x Slimming Power
  • Japan Lingzhi 24 Hours Diet
  • 5x Imelda Perfect Slimming
  • 3 Day Diet
  • 7 Day Herbal Slim
  • 8 Factor Diet
  • 7 Diet Day/Night Formula
  • 999 Fitness Essence
  • Extrim Plus
  • GMP
  • Imelda Perfect Slim
  • Lida DaiDaihua
  • Miaozi Slim Capsules
  • Perfect Slim
  • Perfect Slim 5x
  • Phyto Shape
  • ProSlim Plus
  • Royal Slimming Formula
  • Slim 3 in 1
  • Slim Express 360
  • Slimtech
  • Somotrim
  • Superslim
  • TripleSlim
  • Zhen de Shou
  • Venom Hyperdrive 3.0

Why did FDA act against these products?

These products contain undeclared, active pharmaceutical ingredients that may put consumers' health at risk. Some of the amounts of active pharmaceutical ingredients far exceed FDA-recommended levels.

Some of the products claim to be "natural" or to contain only "herbal" ingredients, but actually contain potentially harmful ingredients not listed on the product labels or in promotional advertisements. These products have not been approved by FDA, are illegal, and may be potentially harmful to unsuspecting consumers.

What undeclared ingredients were found?

An FDA analysis found that the undeclared active pharmaceutical ingredients in some of these products include

  • sibutramine, a controlled substance that can cause high blood pressure, seizures, abnormally rapid heart rate (tachycardia), palpitations, heart attack or stroke. It can also interact with other medications and increase patients' risk of unexpected bad side effects (adverse reactions). Sibutramine's safety has also not been established in pregnant and lactating women, or in children younger than 16.
  • rimonabant, a drug not approved for marketing in the United States, has been associated with increased risk of depression and suicidal thoughts. In Europe, where it is approved, rimonabant has been linked to five deaths and 720 adverse reactions over the last two years.
  • phenytoin, an anti-seizure medication
  • phenolphthalein, a solution used in chemical experiments that is a suspected cancer-causing agent

Where are these products sold?

These weight-loss products, some of which are marketed as "dietary supplements," are promoted and sold on various Web sites and in some retail stores.

Is FDA taking further action?

The agency is currently seeking product recalls. FDA may take additional enforcement steps, such as issuing warning letters or initiating seizures, injunctions, or criminal charges.

Tips for consumers

  • If you use any of these weight-loss products, stop taking them and consult your health care professional immediately.
  • Seek guidance from a health care professional before purchasing weight-loss products.
  • Report serious adverse reactions or product quality problems to FDA's MedWatch Adverse Event Reporting program at www.fda.gov/MedWatch/report.htm

This article appears on FDA's Consumer Health Information Web page (www.fda.gov/consumer), which features the latest updates on FDA-regulated products. Sign up for free e-mail subscriptions at www.fda.gov/consumer/consumerenews.html.

For More Information

FDA Press Release
www.fda.gov/bbs/topics/NEWS/2008/NEW01933.html

Information for Consumers
www.fda.gov/cder/consumerinfo/weight_loss_products.htm

FDA MedWatch
www.fda.gov/MedWatch/report.htm

Natural Weight Loss Plans

Monday, November 3, 2008

Soup Recall, Progresso Tomato

General Mills Issues Voluntary Class One Recall Involving One Day’s Production of Progresso Hearty Tomato Soup

Contact:
Tom Forsythe
763-764-6364

FOR IMMEDIATE RELEASE -- Minneapolis, Minn., October 31, 2008 – General Mills is voluntarily recalling a single day's production of Progresso Hearty Tomato soup because of a product labeling issue. Product produced on this date may have been mislabeled, and may contain allergens not listed on the ingredient label, specifically egg, milk, and soy.

There have been no reports of allergic reactions or illnesses associated with this product, however, the possibility of unlabeled allergens makes this a Class One recall.

This voluntary recall includes only 19-ounce Progresso Hearty Tomato soup with the following code date printed on the bottom of the can:

19May10 NV VN-3

A production error resulted in a limited number of cases of Progresso Light Vegetable and Noodle soup being mislabeled as Progresso Hearty Tomato soup. Mislabeled cans have the code date 19May10 NV VN-3 on the bottom of the can, but are mislabeled as Progresso Hearty Tomato soup.

The mislabeled soups contain a product that is visibly different from the soup depicted on the label. Rather than containing Progresso Hearty Tomato soup, a mislabeled can would actually contain Progresso Light Vegetable and Noodle soup. Consumers allergic to egg, milk or soy products, or who are unsure of whether they are allergic to egg, milk or soy products, should not consume product with a Progresso Hearty Tomato label bearing the code date 19May10 NV VN-3 on the bottom of the can, and should contact General Mills for replacement or a full refund.

No other varieties or production dates of Progresso soup are affected by this recall.

Consumers requesting refunds or calling with further questions should contact General Mills Consumer Services at 1-800-200-9377.


Are Your Vitamins Safe?

Friday, October 31, 2008

Biscuits recalled for Melamine contamination

Everlasting Distributors Inc. Issues a Nationwide Recall of Fresh and Crispy Jacobina Biscuits Because of Possible Health Risks

Contact:
Everlasting Distributors Inc.
201-823-0800

FOR IMMEDIATE RELEASE -- October 29, 2008 -- Everlasting Distributors Inc., Bayonne NJ is initiating a nationwide recall of all their 3.88oz (110gm) packages of Fresh and Crispy Jacobina Biscuits because it may be contaminated with Melamine.

Consumers who have the product which is being recalled should stop using it immediately. If consumers have questions about possible health risks, they should contact their doctor.

Product was distributed nationwide in Asian Grocery stores.

The product comes in 3.88oz (110 gm) blue and red color clear plastic package, labeled “JACOBINA”.

No illnesses associated with this product have been reported to date.

The recall was initiated after FDA testing discovered that product was found to contain Melamine. Consumers who have purchased Fresh and Crispy Jacobina Biscuits are urged to return it to the place of purchase for a full refund. Consumers with questions may contact the company at 201-823-0800, Monday to Friday 9:00 to 5:00, Eastern Standard Time.

Whole Food Multis

Tuesday, October 28, 2008

Special Kitty Food Recall

Mars Petcare US Issues Voluntary Recall of a Limited Number of Bags of SPECIAL KITTY® Gourmet Sold at Wal-Mart locations in Fifteen States due to Potential Salmonella Contamination

Contact:
Debra Fair
MARS PETCARE US
(973) 691-3536

FOR IMMEDIATE RELEASE -- FRANKLIN, Tenn. – October 27, 2008 – Mars Petcare US today announced a voluntary recall of a limited number of bags of SPECIAL KITTY® Gourmet Blend dry cat food sold at Wal-Mart locations in Connecticut, Delaware, Massachusetts, Maryland, Maine, North Carolina, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, Virginia, Vermont, and West Virginia. The pet food is being voluntarily recalled following a positive test result indicating a potential contamination with Salmonella.

This product should not be sold or fed to pets. Pet owners should dispose of product in a safe manner (example, a securely covered trash receptacle) and return the empty bag to the store where purchased for a full refund.

Salmonella can cause serious infections in dogs and cats, and, if there is cross contamination caused by handling of the pet food, in people as well, especially children, the aged, and people with compromised immune systems. Healthy people potentially infected with Salmonella should monitor themselves for some or all of the following symptoms: nausea, vomiting, diarrhea or bloody diarrhea, abdominal cramping and fever. On rare occasions, Salmonella can result in more serious ailments, including arterial infections, endocarditis, arthritis, muscle pain, eye irritation, and urinary tract symptoms. Consumers exhibiting these signs after having contact with this product should contact their healthcare providers.

Pets with Salmonella infections may be lethargic and have diarrhea or bloody diarrhea, fever, and vomiting. Some pets will have only decreased appetite, fever and abdominal pain. Animals can be carriers with no visible symptoms and potentially infect other animals or humans. If your pet has consumed the recalled product and has these symptoms, please contact your veterinarian.

There have been no complaints or reports of illness resulting from consumption or handling of the recalled product.

Pet owners who have questions about the recall should call 1-877-568-4463 or visit www.petcare.mars.com.

Recalled Pet Food
Product: SPECIAL KITTY® Gourmet Blend Dry Cat Food
Best If Used By Date: AUG 11 09
Best If Used By Date Location: Back of bag
Production Lot Code: 50 XXXX X (Found on back of bag just after "Best If Used By" date. Consumers should look for "50" as the first two digits of the second line.)
UPC Code: UPC code numbers can be found directly underneath the bar code on the package. Please find recalled pet food UPC information below.

3.5 lb.

SPECIAL KITTY® Gourmet Blend

81131 17546

7 lb.

SPECIAL KITTY® Gourmet Blend

81131 17547

18 lb.

SPECIAL KITTY® Gourmet Blend

81131 17548

Affected Stores: Wal-Mart locations in Connecticut, Delaware, Massachusetts, Maryland, Maine, North Carolina, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, Virginia, Vermont, and West Virginia.

In an effort to prevent the transmission of Salmonella from pets to family members and care givers, the FDA recommends that everyone follow appropriate pet food handling guidelines when feeding their pets. A list of safe pet food handling tips can be found at: www.fda.gov/consumer/updates/petfoodtips080307.html

Pet owners who have questions about the recall should call 1-877-568-4463 or visit www.petcare.mars.com.

Whole Food Multis

Friday, October 24, 2008

Harry and David, Moose Munch Recall

Harry and David Issues Nationwide Allergy Alert on Undeclared Pecans in Harry & David Moose Munch Confection, Milk Chocolate Gingerbread

Contact:
Mr. Bill Ihle EVP, Corporate Relations
541 864-2145 (Media Calls Only)

FOR IMMEDIATE RELEASE -- October 22, 2008 -- Harry and David, of Medford, Oregon, is voluntarily recalling approximately 400 1 lb. 4 oz. boxes labeled Harry & David Moose Munch Confection, Milk Chocolate Gingerbread because the package may contain a different Moose Munch product which contains pecans not declared on the ingredient statement. People who have an allergy or severe sensitivity to pecans run the risk of serious or life-threatening allergic reaction if they consume this product.

Affected product was distributed throughout the United States under the Harry & David brand only in Harry and David stores.

Harry and David is recalling 1 lb. 4 oz. boxes of Harry & David Moose Munch Confection, Milk Chocolate with a "Best if used by" date of 06/28/09. The "Best if used by" date is located on a sticker on the bottom of the box. The bottom of the box also has the stock identifying number RSD142014 printed on it. This lot of product was sold beginning 10/09/08. The popcorn-based confection is packaged in 1 lb. 4 oz. brown and white paperboard boxes. The boxes have a slight wedge shape and feature a large white moose image on the front. Inside the boxes are clear plastic bags of the confection.

There have been no illnesses or injuries reported to date. Anyone concerned about an illness/injury should contact a physician immediately.

This problem, which was discovered on October 21st, 2008, occurred because Dark Chocolate Butter Pecan Moose Munch® Confection was inadvertently packed in a Milk Chocolate Gingerbread outer box. It is estimated that fewer than 60 such boxes were produced.

Consumers with product may return it to any Harry and David retail store for a full refund. Consumers with questions about the recalled product may phone the Harry and David Customer Service division at 800-233-1101, 24 hours a day.

#

www.fda.gov

Whole Food Multis

Italiana Cuccine Recall, Allergy Alert!

Nonna's Real Italiana Cuccine Issues an Allergy Alert on Undeclared Milk, Soy, and Wheat in Stuffed Artichokes

Contact:
Ruby Lovecchio
214-535-7630

FOR IMMEDIATE RELEASE -- October 22, 2008 -- Nonna's Real Italiana Cuccine of Slidell, LA is recalling the following Nonna's Real Italiana Cuccine brand products:

  • Stuffed Artichokes, Net Wt. 15 oz.

This product is being recalled because it contains milk, soy, and wheat that was distributed in packaging that does not reveal the presence of these ingredients. People who have an allergy or severe sensitivity to milk, soy, or wheat run the risk of a serious or life-threatening allergic reaction if they consume these products.

This product is distributed through retailers in the Greater New Orleans area including the Northshore from October 8, 2008 to October 17, 2008. The product is individually wrapped in clear plastic wrap bearing the label: "STUFFED ARTICHOKE, Net Wt. 15 oz., NONNA'S REAL ITALIANA CUCCINE".

There have been no reported illnesses to date.

The above omission was found during a routine FDA inspection. Distribution of these products has been suspended while we correct the labels to include all ingredients.

Consumers who have questions or purchased the product may contact Ruby Lovecchio at 214-253-7630 for information and return instructions.

www.fda.gov

Whole Food Multivitamins

Hartz Recall, Chicken Rawhide has Salmonella

The Hartz Mountain Corporation Voluntarily Recalls One Specific Lot of Nationwide Chicken-Basted Rawhide Chips Because of Possible Health Risk

Contact:
John Mullane
(914) 712 9150

FOR IMMEDIATE RELEASE -- October 20, 2008 -- The Hartz Mountain Corporation, Secaucus, NJ is voluntarily recalling one specific lot of Hartz Chicken-Basted Rawhide Chips due to concerns that one or more bags within the lot are potentially contaminated with Salmonella. Hartz is fully cooperating with the US Food and Drug Administration in this voluntary recall.

Salmonella can cause serious infections in dogs, and, if there is cross-contamination caused by handling of the rawhide chips, in people as well, especially children, the aged, and people with compromised immune systems. Healthy people potentially infected with Salmonella should monitor themselves for some or all of the following symptoms: nausea, vomiting, diarrhea or bloody diarrhea, abdominal cramping and fever. On rare occasions, Salmonella can result in more serious ailments, including arterial infections, endocarditis, arthritis, muscle pain, eye irritation, and urinary tract symptoms. Consumers exhibiting these signs after having contact with this product should contact their healthcare providers.

Pets with Salmonella infections may be lethargic and have diarrhea or bloody diarrhea, fever, and vomiting. Some pets will have only decreased appetite, fever and abdominal pain. Animals can be carriers with no visible symptoms and can potentially infect other animals or humans. If your pet has consumed the recalled product and has these symptoms, please contact your veterinarian.

The product involved is 4,850 - 2 pound plastic bags of Hartz Chicken-Basted Rawhide Chips, lot code JC23282, UPC number 3270096463 which were distributed to a national retail customer. While the normal testing that Hartz conducts through an independent outside laboratory did not detect the presence of Salmonella in any Hartz rawhide products, sample testing conducted by another laboratory did indicate the presence of the bacteria in a sample bag of the Chicken-Basted Rawhide Chips. Hartz is aggressively investigating the difference in test results and the potential source of the problem.

Although Hartz has not received any reports of animals or humans becoming ill as a result of coming into contact with this product, Hartz is taking immediate steps to remove the product from all retail stores and distribution centers. Dog owners who purchased this product should check the lot code on their bag, and, if the code is not visible, or if the bag has lot code JC23282 imprinted thereon, they should immediately discontinue use of the product and discard it in a proper manner.

Consumers can contact Hartz at 1-800-275-1414 with any questions they may have and to obtain reimbursement for purchased product.

Vitamin Girl Shop, Whole Food Multis

Saturday, October 18, 2008

FDA Cookie Recall

Lotte USA, Inc. Initiates Nationwide Recall of Koala's March Crème filled Cookies

Contact:
Lotte USA, Inc.
269-963-6664

FOR IMMEDIATE RELEASE -- October 17, 2008 -- Lotte USA, Inc., Battle Creek, MI initiated a recall of all Koalas' March Cookies on September 29, 2008 because they were produced in China and they may be contaminated with melamine. The products are packaged in a plastic overwrap and the recall includes the following products:

Koala March King Size Chocolate 1.8 oz 50 grams
UPC 0 81900 00001 7

Koala March King Size Strawberry 1.8 oz/50 grams
UPC 0 81900 00007 9

Koala March King Size White Chocolate 1.8 oz/50 grams
UPC 0 81900 00011 6

Koala March Family Pack Chocolate 9.5 oz/270 grams
UPC 0 81900 08001 9

Koala March Family Pack Strawberry 9.5 oz/270 grams
UPC 0 81900 08002 6

Koala March Family Pack White Chocolate 9.5 oz/270 grams
UPC 0 81900 08011 8

Koala March Family Pack Chestnut 9.5 oz/270 grams
UPC 0 81900 08010 1

Koala March Family Hawaii Chocolate 9.5 oz/270 grams
UPC 0 81900 08003 3

Koala March Family Hawaii Pineapple 9.5 oz/270 grams
UPC 0 81900 08004 0

The product were distributed nationwide and to Canada through wholesale distributors and retail stores. Lotte USA, Inc. is not aware of any illnesses or injuries associated with these products.

Individuals who have experienced any health problems after consuming the Koala March cookies are advised to contact their health care professional.

Customers who have purchased Koala’s March cookies are urged to return them to the place of purchase for a full refund or discard it in their trash. Consumers with questions may contact the company at (269) 963-6664, Monday to Friday, 9:00 to 5:00 Eastern Standard Time.

FDA Home Page

Vitamin Girl Shop, Are your vitamins safe?

Thursday, October 16, 2008

FDA Monitoring Vitamins

....a firm is responsible for determining that the dietary supplements it manufactures or distributes are safe and that any representations or claims made about them are substantiated by adequate evidence to show that they are not false or misleading. This means that dietary supplements do not need approval from FDA before they are marketed...firm does not have to provide FDA with the evidence it relies on to substantiate safety or effectiveness before or after it markets its products.....manufacturers do not need to register themselves nor their dietary supplement products with FDA before producing or selling them......the manufacturer is responsible for establishing its own manufacturing practice guidelines to ensure that the dietary supplements it produces are safe and contain the ingredients listed on the label.....there are no provisions in the law for FDA to "approve" dietary supplements for safety or effectiveness before they reach the consumer.....The manufacturer is responsible for ensuring that the "Supplement Facts" label and ingredient list are accurate, that the dietary ingredients are safe, and that the content matches the amount declared on the label...That is directly from the FDA website, It honestly scares me.

Whole Food Nation has posted this.........

Whole Food Nation’s manufacturing facility, Garden State Nutritionals (GSN), New Jersey is FDA-licensed and certified GMP. GMP, which stands for Good Manufacturing Practices, is a certification given by the National Nutritional Foods Association (NNFA) and NSF International, two independent national nonprofit organizations that employ a uniform set of standards so that consumers can be assured that what’s on the label is also in the box, and that they are receiving pure supplements at accurate dosage levels. GSN has earned the coveted NNFA GMA 'A' rating, and is kosher-approved.

GSN has been manufacturing health supplements since 1977 and supplies diatary supplements to more than 35 countries around the world.

GSN link - http://www.gardenstatenutritionals.com/


  • The Food and Drug Administration (FDA) does not review or approve dietary supplements like Pop a Green™ or Pop a Purple™.
  • The FDA instead licenses factories to manufacture dietary supplements, and issue label guidelines.
  • Pop a Green™ and Pop a Purple™ are manufactured by an FDA-licensed factory that has met all the FDA label guidelines.
  • These guidelines include posting the statement in the box below. (The FDA does review and approve drugs like Vioxx and Celebrex.)
These statements have not been evaluated by the Food and Drug Administration.
This product is not intended to diagnose, treat, cure or prevent any disease.

Whole Food Nation
Are Your Vitamins Safe?
Vitamin Girl Shop

Allergy Alert, Kroger Chocolate Chips Recalled By FDA

Barry Callebaut USA LLC Issues Allergen Alert on Undeclared Milk Protein in Kroger Value Semi Sweet Chocolate Chips

Contact:
Technical: Mr. Bradley Wilson, Director of Quality Assurance
Press: Ms. Sarah O’Neil, Marketing Director
Telephone: 1-866-678-5221

FOR IMMEDIATE RELEASE -- Chicago, IL -- October 10, 2008 – Barry Callebaut USA LLC is conducting a voluntary recall on its product sold by Kroger Stores under the brand "Kroger Value Semi Sweet Chocolate Chips", 12 oz., UPC Code is 11110–86603 and "sell by" date May 30, 2010, as the product may contain undeclared milk protein. The "sell by" date is found printed in black on the end of the bag. People with allergies or severe sensitivity to milk protein may be at risk of serious or life-threatening allergic reaction if they consume this product.

The Kroger Value Semi Sweet Chocolate Chips subject to this recall were sold in Kroger stores in Alabama, Arkansas, Georgia, Kentucky, Louisiana, Mississippi, North Carolina, South Carolina, Tennessee, Texas, Virginia and West Virginia.

This recall was determined necessary after it was identified by 3 consumers that packages of Kroger Value Semi Sweet Chocolate Chips may also contain chocolate chips with undeclared milk protein. The package ingredient label does not identify that the product may contain milk protein.

Consumers who have purchased Kroger Value Semi Sweet Chocolate Chips with the above indicated code date may return the product to the place of purchase for a full refund. Consumers with any questions may contact Barry Callebaut at 1-866-678-5221.

http://www.fda.gov
Vitamin Girl Shop

Tuesday, October 14, 2008

Bread Recall by FDA

Arnold Foods Company, Inc. Issues Allergy Alert on Undeclared Nuts in Brownberry Whole Grains Bread 100% Whole Wheat

Contact:
Lou Minella
215-323-9210

FOR IMMEDIATE RELEASE -- HORSHAM, PA, October 8, 2008 – Arnold Foods Company, Inc. is recalling BROWNBERRY brand Whole Grains BREAD 100% WHOLE WHEAT (1 LB 8 OZ) because it may contain undeclared almonds, walnuts and hazelnuts. People who have an allergy to these nuts run the risk of life threatening or serious allergic reactions if they consume the product.

The BROWNBERRY brand Whole Grains BREAD 100% WHOLE WHEAT was sold in Illinois, Indiana, Iowa, Minnesota and Wisconsin. This product was sold through retail stores and bakery thrift outlets.

The product being recalled has a green twist tie with a code date of "Oct 11" printed on the bread bag. No other Arnold brand or Brownberry brand products are affected.

The company announced the recall after receiving a report from one consumer who found nuts in the bread which are known allergens but were not listed on the ingredient statement. The company has received no other reports from consumers. There are no reports of injuries.

All packages with the above code date have been removed from store shelves.

Consumers with allergies to nuts who have purchased the product can return the product to its place of purchase for a full refund or call the company at 1-800-984-0989.

Are Your Vitamins Safe?

Milk Recalls

HUA XIA Food Trade USA, Inc. Recalls YILI Brand Sour Milk Drink and YILI Brand Pure Milk Drink, Because of Possible Health Risk

Contact:
HUA XIA Food Trade USA, Inc.
(917) 216-0575

FOR IMMEDIATE RELEASE -- October 10, 2008 -- HUA XIA Food Trade USA, Inc. of Flushing, NY, is recalling YILI Brand Sour Milk Drink packaged in 250ml flexible paperboard boxes (all codes and all lots are affected) and YILI Brand Pure Milk Drink packaged in 250ml flexible paperboard boxes (all codes and all lots are affected) because it may be contaminated with melamine.

Consumers who have the product which is being recalled should stop using it immediately. If consumers have questions about possible health risks, they should contact their doctor.

YILI Brand Sour Milk Drink and YILI Brand Pure Milk Drink were distributed to New York City through Asian retail grocery stores.

PRODUCTS:

  1. YILI Brand Sour Milk Drink is packaged in 250ml flexible paperboard boxes with blue, red and green Chinese writing. There is a picture of an Asian man in a green shirt and white tie clapping his hands on the face of the box. All codes and all lots are affected.
  2. YILI Brand Pure Milk Drink packaged in 250ml flexible paperboard boxes with black, red and white writing, the writing on the package is in both English and Chinese. There is a picture of two cows playing basketball on the face of the box. All codes and all lots are affected.

No illnesses have been reported to date.

The recall was initiated after FDA testing discovered that the product was found to contain Melamine.

Consumers who have purchased YILI Brand Sour Milk or YILI Brand Pure Milk Drink are urged to return it to the place of purchase for a full refund. Consumers with questions may contact the company at (917) 216-0575, Monday to Friday, 9:00 to 5:00, Eastern Standard Time.

Are Your Vitamins Safe?