Thursday, April 24, 2008

Tainted Chinese imports spur calls to protect consumer

Toxic blood thinner may have killed as many as 81 people, US says.
Lead in toys. Melamine in pet food. Toxic chemicals in toothpaste. And now, tainted pharmaceuticals.
The unfolding scandal of contaminated blood thinner from China is the latest in a string of revelations about dangerous imports from a country that has risen to become manufacturer to the world.
US lawmakers now are pushing for more protection for American consumers, as hearings in Congress this week have made clear. Even the head of the Food and Drug Administration (FDA) says he needs more money – and a new approach – to try and ensure that products entering the country are safe.
http://www.csmonitor.com/2008/0424/p02s02-usgn.html

Wednesday, April 9, 2008

Malt-O-Meal Company Initiates Voluntary Recall of Unsweetened Puffed Rice and unsweetened Puffed Wheat Cereals Due to Possible Health Risk

Malt-O-Meal announced today that it is voluntarily recalling its unsweetened Puffed Rice and unsweetened Puffed Wheat Cereals produced with "Best If Used By" codes between April 8, 2008 (coded as "APR0808") and March 18, 2009 (coded as "MAR1809") because they may have the potential to be contaminated with Salmonella.

The recalled product was distributed nationally, marketed under the Malt-O-Meal brand and as some private label brands including Acme, America's Choice, Food Club, Giant, Hannaford, Jewel, Laura Lynn, Pathmark, Shaw's, ShopRite, Tops and Weis Quality. A comprehensive listing of impacted products can be found at www.malt-o-meal.com/recallinfo.

No illnesses have been reported to date in connection with this situation. All other Malt-O-Meal products are unaffected by this action and are safe for continued sale and consumption. The products affected by this recall represent less than one-half of one percent of the company's annual production of ready-to-eat cereal.

"Our first and highest priority is the safety of the consumers who use our products," said Malt-O-Meal President and CEO Chris Neugent. "It's important that we spread the word about this situation quickly and broadly in order to remove even the slightest possibility that someone will consume something harmful. We apologize for this situation and promise to do everything to complete the recall as quickly as possible."

The recall was initiated after the company's internal routine food safety testing detected the presence of Salmonella in a product produced on March 24, 2008. The company immediately commenced an investigation to determine the root cause of this one positive finding as well as the extent of any possible exposure. Initial results from this follow-up investigation indicate that additional product may have been exposed to this contaminant. Thus, out of an abundance of caution to protect consumers, the company has chosen to voluntarily remove all unsweetened Puffed Rice and unsweetened Puffed Wheat products with "Best If Used By" codes between April 8, 2008 (coded as "APR0808") and March 18, 2009 (coded as "MAR1809"). Investigation into the source of the Salmonella has determined a root cause of this situation and corrective measures have been taken to ensure that there is no reoccurrence of this issue.

Persons infected with Salmonella may experience a variety of symptoms and illnesses. According to the U.S. Food and Drug Administration, persons infected with Salmonella may experience fever, diarrhea, nausea, vomiting, and abdominal pain. In rare circumstances, infection with Salmonella can result in more severe illnesses, some potentially life threatening.

Consumers who have purchased any products covered by this recall are urged to return them to the place of purchase for a full refund. Consumers with questions may contact the company at 1-877-665-9331. Information regarding this recall, including images of the Malt-O-Meal product packaging, also will be posted to the company's website at www.malt-o-meal.com/recallinfo.

Plush Insect Toys Recalled by Dollar Tree Stores Due to Choking Hazard

Name of Product: Cuddly Cousins Plush Insect Toys
Units: About 300,000
Retailer: Dollar Tree Stores Inc., of Chesapeake, Va.
Importer: Greenbrier International Inc., of Chesapeake, Va.
Hazard: The recalled plush insect toys contain small parts, posing a choking hazard to small children.
Incidents/Injuries: None reported.
Description: The recalled plush insect toys come in six designs: Lady Bug, Bumble Bee, Caterpillar, Snail and two Butterflies. The toys measure nine inches to 10 ½ inches in length. The lady bug is black with six legs, a red back with four black dots and orange eyelids. The bumble bee is black and yellow with six legs, sheer white wings and red eyelids. The caterpillar has four sections that are yellow, pink, green and orange with seven legs connected on each side and purple eyelids. The snail is yellow with dark pink eyelids and a two tone brown shell. One butterfly is blue and yellow with sheer purple wings with four orange dots and light pink eyelids. The second butterfly is a two tone pink with blue eyelids and sheer green wings with four yellow dots. The product number is 903995 and UPC is 6 39277 03995 8 with a date code of 71.
Sold at: Dollar Tree, Dollar Bill$, Dollar Express, Greenbacks, Only One $1, and Deal$ stores nationwide from March 2007 through December 2007 for about $1.

Manufactured in: China

Remedy: Consumers should immediately take the recalled plush insect toys from children and return them to the store where purchased for a full refund.
Consumer Contact: For additional information, contact Dollar Tree Stores Inc. at (800) 876-8077 between 9 a.m. and 5 p.m. ET Monday through Friday, or visit the firm's Web site at www.dollartree.com

Children's Board Book Sets Recalled By Dalmatian Press Due to Choking Hazard

Name of Product: Little Builder Children's Board Book Sets with Toys
Units: About 17,000
Importer: Dalmatian Press LLC, of Franklin, Tenn.
Hazard: The cylinder on the toy concrete mixer and the tailgate on the toy dump truck can detach, posing a choking hazard to young children.
Incidents/Injuries: None reported.
Description: This recall involves Little Builder Children's Board Book sets with ISBN 1-49373-215-9. The sets include four concept board books (colors, tools, 123, shapes) and two toy trucks (dump truck and concrete mixer truck).
Sold at: Wal-Mart, Levy Home Entertainment, Lion Sales of NW Brunswick, Farris Wholesale Outlet, Crane Book Sales, Ingram Book Co., BPDI Corp., Books A Million and Christmas Tree Shop stores nationwide and on the Internet at Amazon.com and Barnes&Noble.com from August 2007 through February 2008 for about $9.

Manufactured in: China

Remedy: Consumers should immediately take the recalled toys from young children and return the entire book set to the retailer where purchased for a refund or exchange.
Consumer Contact: For additional information, contact Dalmatian Press toll-free at (866) 418-2572 between 8 a.m. and 4 p.m. CT Monday through Friday or visit the firm's Web site at www.Dalmatianpress.com

Magnetic Dart Boards Recalled By Henry Gordy Int'l; Ingested Magnets Pose Aspiration and Intestinal Hazards

Name of Product: Fun 'N Games Magnetic Dart Boards
Units: About 870,000
Importer: Henry Gordy International Inc., of Plainfield, N.J.
Hazard: Small magnets at the ends of the darts can detach. Magnets found by young children can be swallowed or aspirated. If more than one magnet is swallowed, the magnets can attract each other and cause intestinal perforations or blockages, which can be fatal.
Incidents/Injuries: None reported.
Description and Models: This recall involves magnetic dartboards with a black, green, blue, and white checkered design, and a red bulls eye. The magnetic dartboards measure about 5 ½ inches wide and were sold with two 2 ¾-inch long magnetic darts. The darts magnetically attract to the dart board.
Sold Exclusively at: Family Dollar stores nationwide from September 2002 through March 2008 for about $1.

Manufactured in: China

Remedy: Consumers should immediately take the recalled magnetic boards away from children and return them by first class mail to: Henry Gordy International Inc., 809A Market Street, Hermann, MO 65041 for a full refund including tax and shipping costs.
Consumer Contact: For additional information, contact Henry Gordy International Inc., at (888) 790-2700 between 8 a.m. and 4 p.m. CT Monday through Friday.

Pennsylvania Agriculture Department Warns Consumers of Tainted Raw Milk Sold By Clarion, Crawford County Dairies

Consumers who purchased raw milk from Piney Ridge dairy farm in New Bethlehem, Clarion County, and Clark and Elaine Duncan’s farm in Meadville, Crawford County, anytime after March 10 should discard it immediately due to the risk of Listeria Monocytogenes contamination, Agriculture Secretary Dennis Wolff said today.

Raw milk is milk that has not been pasteurized or homogenized. Pennsylvania farms selling raw milk must be permitted and inspected to reduce health risks associated with the unpasteurized products. In 2007, a previous case of Listeria Monocytogenes was found at Piney Ridge dairy.
"During routine testing, samples taken at the dairies tested positive for Listeria Monocytogenes," said Wolff. "If consumers have raw milk from these farms, they should discard it immediately."

No illnesses have been reported as a result of the potential contamination, but if people who consumed the raw milk become ill, they should consult their physicians.

The Department of Agriculture has suspended sales of raw milk at the dairies and is requiring corrective action be taken. Samples were taken from the farms on March 31; they tested positive for Listeria Monocytogenes on April 4.

Multiple laboratory samples must test negative before sales can resume.

Symptoms of Listeriosis are fever, muscle aches, and sometimes gastrointestinal symptoms such as nausea or diarrhea. If infection spreads to the nervous system, symptoms such as headache, stiff neck, confusion, loss of balance or convulsions can occur.

Infected pregnant women may experience only a mild, flu-like illness, but infections during pregnancy can lead to miscarriage or stillbirth.

Symptoms of Listeriosis can appear in four days to three weeks.

Federal Authorities Seize More Than $100,000 of Unapproved Drugs Marketed as "Natural Supplements"

At the request of the U.S. Food and Drug Administration, today U.S. Marshals seized more than 14,000 dosage units of Shangai Regular, Shangai Ultra, Super Shangai, Naturalë Super Plus, and Lady Shangai. Although labeled as natural supplements, the seized products were all marketed to treat erectile dysfunction (ED), impotency, and/or to provide sexual enhancement, which caused them to be drugs under the Federal Food, Drug, and Cosmetic Act.

The seized products, valued at more than $100,000, contain undeclared active ingredients found in FDA-approved prescription drugs for ED, or similar substances. Use of these products may result in serious side effects and may interact in dangerous ways with medications that a consumer may already be taking.

“The FDA will not tolerate companies marketing unapproved drugs -- products that have not proven to be safe or effective -- as dietary supplements," said Margaret O'K. Glavin, associate commissioner for regulatory affairs. “The agency will pursue necessary legal action to make sure companies and their executives manufacture and distribute safe drug products."

The seized products, which originated in China, are packaged and distributed by Shangai Distributors, Inc. of Coamo, Puerto Rico. Although the products' labels state they are natural supplements, these products are drugs and their sale is illegal without FDA approval. Before a new drug product may be legally marketed, it must be shown to be safe and effective.

In response to a consumer complaint, the FDA conducted an inspection of Shangai Distributors Inc., in November 2007. The FDA's investigation and testing revealed that the seized products contained active drug ingredients found in FDA-approved ED prescription drugs and/or a substance with a structure similar to such drugs that may cause similar side effects and drug interactions. None of the drug ingredients are listed on the labels of any of the seized products.

The undeclared ingredients in these products may interact with nitrates found in some prescription drugs (such as nitroglycerin) and can 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 medical conditions. Because they may have been advised against taking ED drugs, they may seek out products like these because they are marketed as “all natural" or as not containing the active ingredients in approved, prescribed ED drugs. Additionally, because the manufacturing source of the active ingredients in these products is unknown, consumers should be aware that the safety, efficacy, and purity of these ingredients can not be validated.

Despite being advised of the findings and the potential adverse health risk posed by the seized products and that regulatory action was possible, the company did not take any action to correct the violations. The FDA issued a press release on December 28, 2007 advising consumers not to buy or use the products. Prior to the seizure, the Puerto Rico Department of Health embargoed the seized products to protect the citizens of Puerto Rico and to support the FDA's enforcement actions.

The FDA advises consumers who have used any of these products to discontinue use and consult their health care providers if they have experienced any adverse events that they believe are related to the use of these products. Consumers and health care professionals can report adverse events to FDA's MedWatch program at 800-FDA-1088 or online at
www.fda.gov/medwatch/report.htm. FDA recommends that consumers talk to their health care provider about FDA-approved treatments for erectile dysfunction. FDA may take further regulatory actions to protect consumers from these illegal products.

The complaint was filed by Assistant U.S. Attorney Jose M. Pizarro, deputy chief, Civil Division, United States Attorney's Office, District of Puerto Rico.

North Aire Market Issues Allergy Alert on Possible Traces of Almonds in Chicken Dumpling Soup Mix

North Aire Market of Shakopee, MN is recalling 99 boxes of Chicken Dumpling Soup Mix because they may contain undeclared traces of almonds. The 99 boxes were sold in various parts of the country primarily to specialty gift shops and through the company’s web site under the brand, “Maggie & Mary’s Chicken Dumpling Soup Mix.”

The lot codes related to this recall are: 0730810, 0720810, 0910810, 0920811, 0920810, 0930810, 0980810, and are found on the bottom of the retail box.

The dumplings in the soup mix may have may have been exposed to residual traces of almonds which may have been present on machinery used to package an almond containing product earlier. However, no almond traces were found on the machinery, no almond traces were found within any dumpling packages, and there are no reports of illness associated with this recall. This recall is precipitated by an uncertainty as to whether one step in the sanitizing procedure was properly followed to make the machinery ready to package the 99 units.

The Company has been in phone contact with 86 % of the stores which received this product and is making attempts to reach the remaining stores.

Consumers who have purchased Maggie & Mary’s Chicken Dumpling Soup Mix are urged to contact North Aire Market at 800-662-3781 and will be given a full refund of the purchase price of the product.
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OKK Trading Recalls Toy Robots Due to Violation of Lead Paint Standard

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: Interchange Robot Toys
Units: About 2,000
Importer/Retailer: OKK Trading Inc., of Commerce, Calif.
Hazard: Surface paints on the toys contain excessive levels of lead, violating the federal lead paint standard.
Incidents/Injuries: None reported.
Description: The recalled robot toys were sold as a four piece set with various colored robots each carrying a gun in one hand and a shield in the other. "Interchange Robot" is printed on the outside packaging of the product.
Sold at: Dollar stores nationwide from October 2007 through December 2007 for about $1.

Manufactured in: China

Remedy: Consumers should immediately take these robot toys away from children and return the toys to the store where purchased for a refund.
Consumer Contact: For additional information, contact OKK Trading toll-free at (877) 655-8697/OKK-TOYS between 8:30 a.m. and 5:30 p.m. PT Monday through Friday or visit the firm's Web site at www.okktrading.com

FDA Finds Hazardous Levels of Selenium in Samples of "Total Body Formula" and"Total Body Mega Formula"

The U.S. Food and Drug Administration announced today that it has found hazardous levels of selenium in samples of certain flavors of the dietary supplement products "Total Body Formula" and "Total Body Mega Formula." The FDA has received 43 reports of persons from nine states who experienced serious adverse reactions using these products.

On March 27, the FDA warned consumers not to purchase or use "Total Body Formula" in flavors Tropical Orange and Peach Nectar and "Total Body Mega Formula" in the Orange/Tangerine flavor of these products after receiving reports of adverse reactions in users in Florida and Tennessee (www.fda.gov/bbs/topics/NEWS/2008/NEW01812.html). The adverse reactions generally occurred after five to 10 days of daily ingestion of the product, and included significant hair loss, muscle cramps, diarrhea, joint pain, deformed fingernails, and fatigue.

Selenium, a naturally occurring mineral, is needed only in very small amounts for good health. Selenium can boost the immune system. Generally, normal consumption of food and water provides adequate selenium to support good health. Excessive intake of selenium is known to cause symptoms to include significant hair loss, muscle cramps, diarrhea, joint pain, fatigue, loss of finger nails and blistering skin.

Presently, FDA has 43 reports of adverse reactions including cases from Alabama, Florida, Georgia, Kentucky, Michigan, New Jersey, North Carolina, Tennessee, and Texas.

Analyses of samples of the products by FDA laboratories have now found most of the samples contain extremely high levels of selenium--up to 40,800 micrograms per recommended serving, or more than 200 times the amount of selenium per serving (i.e., 200 micrograms) indicated on the labels of the products.

The FDA continues to investigate the matter to determine how excessive amounts of selenium were added to the products.

FDA is advising consumers to stop using "Total Body Formula" in flavors Tropical Orange and Peach Nectar and "Total Body Mega Formula" in the Orange/Tangerine flavor and discard them by placing them in a trash receptacle outside of the home. "Total Body Formula" products are sold in eight-ounce and 32-ounce plastic bottles. "Total Body Mega Formula" is sold in 32-ounce plastic bottles. Both product lines are distributed by Total Body Essential Nutrition of Atlanta, which is listed on the products' labels.

Consumers who have been taking the products and have experienced adverse reactions should consult their health care professional. Consumers and health care professionals are encouraged to report adverse events to the FDA's MedWatch program at 800-FDA-1088 or online at www.fda.gov/medwatch/how.htm.

The sole distributor of the "Total Body Formula" and "Total Body Mega Formula" products has voluntarily recalled the affected products. According to the company, the products were distributed nationwide.

More information about selenium and its toxic effects is available at this link to the Centers for Disease Control and Prevention's Agency for Toxic Substances and Disease Registry: www.atsdr.cdc.gov/tfacts92.html.