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Thread: FDA Alerts and Recalls...

  1. #21
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    : FDA Alerts and Recalls...

    WholeSoy & Co. Issues Allergy Alert on Undeclared Dairy in Blueberry Yogurt

    Contact:
    WholeSoy & Co.
    415-434-3020

    FOR IMMEDIATE RELEASE -- San Francisco, CA -- June 6, 2007 -- WholeSoy & Co. of San Francisco, CA is recalling 34,656 cups of WholeSoy & Co. Blueberry yogurt because it may contain undeclared dairy. People who have an allergy or severe sensitivity to dairy run the risk of serious or life-threatening allergic reaction if they consume these products.

    The yogurt was distributed nationwide through retailers.

    This batch of blueberry has "best by" date of June 22. The UPC code is 664372600086. The containers are 6oz plastic yogurt cups.

    No permanent side effects or illnesses have been reported to date.

    The recall was initiated after allergy tests confirmed the presence of dairy in samples sent for testing after two customers reported allergic reactions. Subsequent investigation has not revealed the source of contamination. The investigation into the cause continues.

    Consumers who have purchased WholeSoy & Co. blueberry yogurt with "best by" date June 22 are urged to return it to the place of purchase for a full refund. Consumers with questions may contact the company at
    1-877-569-6376.

  2. #22
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    : FDA Alerts and Recalls...

    Tristar Food Recalls Ferrari Chocolate Due to Undeclared Peanuts and Aflatoxins

    Contact:
    Tristar Food Wholesale
    201-938-2590

    FOR IMMEDIATE RELEASE -- Jersey City, NJ – June 6, 2007 -- Tristar Food Wholesale, 115 Amity Street, Jersey City, NJ 07304 is recalling Ferrari Chocolate because it contains undeclared peanuts. People who have severe sensitivity to peanuts run the risk of serious or life threatening allergic reactions if they consume this product. The candy also contains aflatoxins in excess of the Food and Drug Administration's action level of 20 parts per billion. Aflatoxins are by products of certain fungi and, with chronic exposure, are potential carcinogens.

    The recalled Ferrari Chocolates, a product of China, is distributed in 280g and 240g per box. The Ferrari chocolate was sold in New York City and in New Jersey.

    The recall was initiated after routine sampling by New York State Department of Agriculture and Markets Food Inspectors and subsequent analysis by the Department's food laboratory personnel revealed the presence of undeclared peanuts and aflatoxins in the product. No illnesses have been reported to date in connection with this problem.

    Consumers who have purchased Ferrari chocolate should return it to the place of purchase. Consumers with questions may contact the company at 201-938-2590 for Michael.

  3. #23
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    : FDA Alerts and Recalls...

    Counterfeit Colgate Toothpaste Found

    Contact:
    Allison Klimerman 212-310-3770
    Tom Paolella 212-310-2774

    FOR IMMEDIATE RELEASE -- New York, New York -- June 14, 2007 -- The Colgate–Palmolive Company today warned that counterfeit toothpaste falsely packaged as "Colgate" has been found in several dollar-type discount stores in four states: New York, New Jersey, Pennsylvania, and Maryland. There are indications that this product does not contain fluoride and may contain Diethylene Glycol. The Company stated that it does not use, nor has ever used, Diethylene Glycol as an ingredient in Colgate toothpaste anywhere in the world.

    The counterfeit toothpaste can be easily recognized because it is labelled as "Manufactured in South Africa." Colgate does not import toothpaste into the United States from South Africa. In addition, the counterfeit packages examined so far have several misspellings including: "isclinically" "SOUTH AFRLCA" "South African Dental Assoxiation".

    Counterfeit toothpaste is not manufactured or distributed by Colgate and has no connection with the Company whatsoever. Colgate is working closely with the US FDA to help to identify those responsible for the counterfeit product.

    Consumers who suspect they may have purchased counterfeit product, can call Colgate’s toll-free number at 1 800 468 6502.

  4. #24
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    : FDA Alerts and Recalls...

    Back to Nature Foods Company Issues Allergy Alert on Undeclared Milk Protein in Back to Nature Sesame Ginger Rice Thins Crackers

    Contact:
    Back to Nature
    800-433-9361

    FOR IMMEDIATE RELEASE -- Madison, WI -- June 13, 2007 -- The Back to Nature Foods Company is recalling 26,472 boxes of Back to Nature Sesame Ginger Rice Thins Crackers with a "Best When Used By" date of 16 May 2007, because a small number of boxes were inadvertently manufactured using a milk ingredient seasoning, and no milk ingredients are declared on the label. 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.

    This product expired on 16 May 2007. The company has voluntarily issued a nationwide recall to alert any milk-allergic consumers who may still have the product at home. The Back to Nature Sesame Ginger Rice Thins Crackers with a "Best When Used By" date of 16 May 2007 were sold in retail grocery and health food stores.

    The Back to Nature Sesame Ginger Rice Thins Crackers with a "Best When Used By" date of 16 May 2007 has a UPC code of 59283-10013 and comes in a 4 oz retail carton. No other varieties of Back to Nature Rice Thins or any other Back to Nature products are impacted by this recall.

    Allergy tests confirmed the presence of milk in samples sent for testing after the company received two consumer reports of allergic reactions. The company's investigation has determined that the wrong seasoning was used in the manufacturing of a very small number of the boxes of crackers.

    The company has consulted with the U.S. Food and Drug Administration, and the agency is aware of the company's actions.

    Consumers are advised not to consume the product and are asked to call 800-433-9361 for a full refund.

  5. #25
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    : FDA Alerts and Recalls...

    Confidence, Inc. Issues a Voluntary Nationwide Recall of all lots of Long Weekend, a Product Marketed as a Dietary Supplement

    Contact:
    Jim Chao
    (516) 767-1870

    FOR IMMEDIATE RELEASE -- June 14, 2007 -- Confidence, Inc. of Port Washington, NY, announced today that it is conducting a voluntary nationwide recall of the Company's supplement product sold under the name Long Weekend. The Company has been informed by the Food and Drug Administration (FDA) that lab analysis of Long Weekend samples found that the product contains undeclared tadalafil, an FDA approved drug used as treatment for male Erectile Dysfunction (ED). The FDA has not approved Long Weekend as a drug; therefore the safety and effectiveness of this product is unknown.

    FDA advises that this poses a threat to consumers because tadalafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. According to the FDA, consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. FDA advises that ED is a common problem in men with these conditions, and they may seek products to enhance sexual performance. FDA advises that tadalafil, may cause side effects, such as headaches and flushing.

    Consumers should discontinue use of Long Weekend and consult their health care professional about approved treatments for erectile dysfunction (ED). FDA encourages men who experience ED to seek guidance from a health care professional.

    The product was sold through mail orders and retailers located nationwide, in Puerto Rico, Canada, the United Kingdom, Russia, and China.

    The recalled Long Weekend is sold in 3-capsule boxes. The capsules are sealed in a foil blister-pack, and the blister-pack is stamped with the LOT # and EXP date. The product is sold under the American Best Nutrition label and bears UPC 809515-0542.

    No illnesses have been reported to the Company to date in connection with this product.

    Confidence, Inc. has taken this voluntary action because it is committed to providing accurate information about its products and because of the concern for the health and safety of consumers. Confidence Inc. is working with the FDA in the recall process. It sincerely regrets any inconvenience to customers.

    Consumers should return any unused Long Weekend, for a refund of the full purchase price or price for the unused portion, to the Company's address in Port Washington, NY, or contact Jim Chao at 516-767-1870 or email jim@confidenceusa.com to receive further instructions for returning the product or with any questions.

    Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

    Online: www.fda.gov/medwatch/report.htm
    Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm.
    Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
    Fax: 1-800-FDA-0178

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    : FDA Alerts and Recalls...

    MainStar America, LLC Issues Urgent Voluntary Nationwide Recall of Toothpaste

    Contact:
    Mr. Ernesto H. Botta
    (305) 637-1127

    FOR IMMEDIATE RELEASE -- Miami, FL -- June 13, 2007 – MainStar America, LLC, Miami, Florida, is initiating a nationwide recall in accordance with the U.S. Food and Drug Administration (FDA) of the toothpaste made in China involving:

    Lot #20060708 – Item # 160-850 Dr. Cool Toothpaste 120 GR./4 OZ.
    UPC # 6926597170008
    Lot #20060708 – Item # 160-852 Superdent Toothpaste 120 GR./4 OZ
    UPC # 6926597170015
    Lot #20060708 – Item # 160-860 Everfresh Smile2 Toothpaste 25 GR./ 1 OZ.
    UPC # 6926597089539
    This recall has been initiated because the products may contain the poisonous chemical diethylene glycol (DEG). DEG is used in antifreeze and as a solvent, and is a Central Nervous System depressant and potent kidney and liver toxin.

    PLEASE RETURN ALL PRODUCTS IMMEDIATELY TO THE STORES WHICH YOU PURCHASED THEM.

    CONSUMERS WHO HAVE THE PRODUCTS SHOULD STOP USING/ RETURN / THROW AWAY.

    Retailers immediately examine your inventory and quarantine product subject to recall. In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of this recall notification.

    This voluntarily nationwide recall is being made with the knowledge of the U.S. Food and Drug Administration. No injuries or illnesses have been reported to date in connection with this problem.

    Adverse Reactions or quality problems experience with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or fax.

    Online: www.fda.gov/medwatch/report.htm
    Regular Mail: use postage-paid FDA form 3500 available at www.fda.gov/MedWatch/getforms.htm
    Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
    Fax: 1-800-FDA-0178

  7. #27
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    : FDA Alerts and Recalls...

    A. Bazzini Co. Inc. Issues an Alert on Undeclared Sulfites in Dried Turkish Jumbo Apricots

    Contact:
    Baher Karim
    718-842-8644 ext. 108

    FOR IMMEDIATE RELEASE -- June 11, 2007 -- A. L. BAZZINI CO., INC. OF BRONX, NEW YORK is recalling DRIED TURKISH JUMBO APRICOTS because they contain undeclared sulfites. People who have a severe sensitivity to sulfites run the risk of serious or life-threatening reactions if they consume these products.

    The Dried Turkish Jumbo Apricots were distributed within the New York State to wholesale distributors.

    The product was distributed in 4.25lb plastic containers (jars) during the month of March 2007 with the following lot number: 7064.

    The recall was initiated after routine sampling by New York State Department of Agriculture and Markets Food Inspectors and subsequent analysis by the Department's Food laboratory personnel revealed the presence of sulfites in the product, which were not declared on the label. The consumption of 10 milligrams of sulfites per serving has been reported to elicit severe reactions in some asthmatics. Anaphylactic shock could occur in certain sulfite sensitive individuals upon ingesting 10 milligrams or more of sulfites. Analysis of the Dried Turkish Jumbo Apricots revealed it contained 73 milligrams per serving.

    Consumers who have purchased Bazzini Brand Dried Turkish Jumbo Apricots are urged to return it to place of purchase for a full refund. Consumers with questions may contact Bazzini at 1-718-842-8644.

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    : FDA Alerts and Recalls...

    Gills Onions Recalls One Lot of Diced Yellow Onions

    Contact:
    Nelia Alamo
    (209) 669-9625

    FOR IMMEDIATE RELEASE -- Oxnard, CA -- June 19, 2007 -- Gills Onions, LLC is recalling diced yellow onions with "Lot #2017-R and a Best if used by 06/16/07." The recall comes after the Washington State Department of Agriculture, during routine testing, detected Listeria monocytogenes in one retail bag of diced yellow onions. Gills Onions is working with both State and Federal officials to determine the cause. At this time there have been no reported illnesses associated with this product.

    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. Anyone with these symptoms, are encouraged to contact their physician.

    The identified lot 2017-R is no longer in production at Gills Onions. As a precautionary measure, both retail and food service diced packs are being recalled. The retail product was labeled with the Trader Joe's brand name and was distributed to stores in Arizona, California, Nevada, New Mexico, Oregon and Washington. The Trader Joe's brand diced onions were packaged in a 10 oz. bag with the Lot 2017-R and a best if used by date of 06/16/07. The lot information for the 10 oz diced retail product can be found printed directly on the back of the package. The foodservice packages were packed in 4/5 lb cartons and labeled under the Gills Onions Brand and the Sysco Natural Brand, both with the Lot 2017-R and the best-if-used by date of 06/16/07 printed directly on the front of the 5 lb bag as well as on the outside carton label. Consumers and Retailers that have this recalled product should either destroy or return to place of purchase.

    "Although no illnesses have been reported and only one 10 oz. retail bag of diced onions tested positive, we want to be sure that all diced products associated with the production lot are accounted for," said Nelia Alamo, VP of Marketing. "We are committed to food safety at all levels and we will always put our customers and our consumer first."

    Questions can be directed to the company at (800) 348-2255.

  9. #29
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    : FDA Alerts and Recalls...

    FDA Warns Consumers Not to Eat Veggie Booty Snack Food
    Risk of Salmonella Contamination



    The U.S. Food and Drug Administration is warning consumers not to eat Veggie Booty snack food, marketed by Robert's American Gourmet, due to possible contamination with Salmonella Wandsworth bacteria that cause gastrointestinal illness.

    FDA advises consumers to throw away any Robert's American Gourmet brand Veggie Booty they have in their home. Veggie Booty is sold in a flexible plastic foil bag in four ounce, one ounce, and one-half ounce packages.

    Veggie Booty is often consumed by children, so parents are encouraged to watch their children, and seek medical care if they observe signs of illness.

    Individuals who have recently eaten Veggie Booty and who have experienced any of the symptoms described below should contact a doctor or other health care provider immediately. Any such illnesses in persons with a recent history of eating Veggie Booty should be reported to state or local health authorities.

    This warning is based on 52 reports of illness across 17 states, beginning in March 2007. Almost all the illnesses have occurred in children under 10 years old, with the most cases in toddlers. Most persons had reported bloody diarrhea; four were hospitalized. FDA learned of the illnesses on June 27 from the Centers for Disease Control and Prevention, which conducted an investigation of the illnesses with state and local health officials. The outbreak is considered likely to be ongoing.

    Salmonella typically causes diarrhea (may be bloody); the diarrhea is often accompanied by abdominal cramps and fever. Symptoms typically begin within one to four days after exposure to the bacteria. In infants, persons with poor underlying health and those with weakened immune systems, Salmonella can invade the bloodstream and cause life-threatening infections.

    States reporting illnesses include: California (seven cases), Colorado (five cases), Connecticut (one case), Georgia (one case), Indiana (one case), Massachusetts (three cases), Minnesota (two cases), New Hampshire (two cases), New Jersey (two cases), New York (13 cases), Oregon (one case), Pennsylvania (three cases), Tennessee (one), Texas (one), Vermont (three cases), Washington (four cases), and Wisconsin (two cases).

    Robert's American Gourmet, of Sea Cliff, N.Y., which markets Veggie Booty, and its contract manufacturer, are fully cooperating with FDA's investigation into the cause of the contamination. Manufacturing and distribution of this product has ceased, and Robert's American Gourmet is recalling all potentially contaminated product, including all expiration dates and lot codes. The product is sold in all 50 states and Canada at retail locations and over the Internet.

    FDA will provide updates as the investigation progresses and more information becomes available.

  10. #30
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    : FDA Alerts and Recalls...

    Product Recall Alerts from June:

    CFM gas lighters, sold for $1 to $4 at Wal-Mart from February 2006 through January 2007...the warning label is printed in Spanish, not English, so not every user will be able to read it. Contact CFM: 866-333-4833

    Rhode Island Novelty children's mood necklaces, sold for about $1 at carnivals, family entertainment centers, small discount stores, and through rinovelty.com from August 2005 through December 2006...the necklaces contain high levels of lead, which is toxic to children if ingested. Contact Rhode Island Novelty: 800-528-5599

    Lari Jewelry Co. Caludia Jublot children's rings, sold for about $3 at Big Lots! stores from October 2004 through January 2006...the rings contain high levels of lead, which is toxic to children if ingested. Contact Lari Jewelry Co: 866-524-0024

    N-Kids girls' drawstring flannel pants and Pine Peak Blues boys' drawstring flannel pants sold for $12-$18 at Nordstrom and through nordstrom.com from July through December 2005...the pants don't meet the Standard for the Flammability of Children's Sleepwear, posing the risk of a burn injury. Contact Nordstrom: 888-282-6060

    Claire's Boutiques children's necklaces, sold for $5-$11 at Claire's stores from December 2005 through December 2006...the necklaces contain high levels of lead, which, if ingested by young children, can result in serious illness. Contact Claire's Boutiques: 866-859-9281

    Sally Foster tea lights, sold with the company's $15 votive candleholders through sallyfoster.com from July through December 2006 and in Sally Foster catalogs from August through December 2006...the candles have a plastic shell that can melt or catch on fire and burn consumers. Contact Sally Foster: 866-723-0925

    Jazwares Link-N-Lite magnetic light-up puzzles sold for about $15 at Target and Kohl's and through amazon.com from June 2006 through January 2007...the toy's magnets can fall out. If multiple magnets are swallowed, they can attach to one another and cause intestinal problems. Contact Jazwares: 800-370-1827

    Cobmex youth jackets with drawstrings, sold for about $30 at children's clothing and school uniform stores from January 2006 through February 2007...the drawstings can get entangled around a kid's neck. Contact Cobmex: 877-926-2639

    Weber Genesis 320 Series gas grills, sold for $450-$770 at home-improvement and hardware stores from November 2006 through February 2007...the gas hose attached to the grill's side burner can crack or break, leak gas, and catch on fire. Contact Weber: 866-249-3237

    Mirraco Bicycles, sold for $265-$550 at authorized Mirraco dealers from November 2006 through January 2007...the front wheel forks can separate and the rider can lose control of the bike and fall. Contact Mirraco: 888-431-7653

    Elite Operations toy sets, sold for $15-$30 at Toys "R" Us and through toysrus.com from January 2006 through February 2007...the paint on the toys contains lead, which is toxic to children if ingested. The toys also have sharp points that could cut kids. Contact Toys "R" Us: 800-869-7787

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