Tuesday, June 02, 2009
China Blocks Twitter, Flickr, Others as Tiananmen Anniversary Looms
Thursday is the 20th anniversary of the Tiananmen Square massacre, and as a foretaste, Chinese users were denied access to Blogger, Flickr, Twitter, Livejournal, Tumblr, the Huffington Post and Microsoft's Live.com, Hotmail, its MSN Space blog tool and its new search engine Bing, according to various reports.
"Looks like Twitter has been.....http://www.foxnews.com/story/0,2933,524339,00.html
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Thursday, March 19, 2009
Toxic Chemicals in Children's Bath Products Trigger International Outcry
In the U.S., Sen. Diane Feinstein (D-Calif.), Rep. Jan Schakowsky (D-Ill.) and Rep. Ed Markey (D-Mass.) have called for greater oversight of the $50 billion cosmetic industry in response to this report. Sen. Kristen Gillibrand (D-N.Y.) has demanded that FDA investigate contaminants in personal care products marketed for babies and young children. In a press release, Gillibrand says, "As a mother of two young children, I expect the baby and child products my family uses to be safe. I find it to be unacceptable that the FDA does not regulate personal care products, as it does food and drugs."
Contrary to industry statements, the U.S. has no safety standards for formaldehyde and 1,4-dioxane in personal care products, nor does it limit the amount of these chemicals in products or require that they be listed on labels. The European Union has banned 1,4-dioxane from personal care products and has recalled products found to contain the chemical. Formaldehyde is banned from personal care products in Japan and Sweden, and restricted in the EU and Canada.
"Once again, the U.S. is lagging when it comes to protecting children's health," said Lisa Archer of the Breast Cancer Fund and coordinator of the Campaign. "The lack of safety standards in the U.S. is disadvantaging American companies. We need updated laws to ensure that American products meet the highest bar of safety and are free of toxic chemicals."
The Campaign's report is the first to document the widespread presence of both formaldehyde and 1,4-dioxane in children's bath products, including Johnson's Baby Shampoo and Sesame Street Bubble Bath.
Since the report release last Thursday, at least 20,000 people have contacted their congressional representatives to demand strengthened FDA oversight and regulation of the cosmetics industry. To date, no action has been reported on the part of the U.S. government or retailers.
Formaldehyde and 1,4-dioxane are known to cause cancer in animals and are listed as probable human carcinogens by the EPA. Formaldehyde can also trigger skin rashes in people who are sensitive to the chemical, at levels found in many of the products tested for the study. The Environmental Protection Agency estimates that babies are 10 to 65 times more vulnerable to cancer-causing chemicals than adults.
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Friday, December 19, 2008
A Marketplace Free From Government Interference
It's all part of competing in a free marketplace. On a world stage, countries develop products for export, and other countries shop around and find the best price and supply to fit their national needs. And if one producing country can find a way to lower its prices, it can gain an important advantage.
That's the way it should work. But when it comes to steel-which the U.S. imports and exports-America is presently locking horns with China. That's because the Chinese government subsidizes the nation's steel companies, creating unfair advantage in an otherwise free marketplace. By covering some of the manufacturing costs, the Chinese government enables its stainless steel producers to charge less for its products.
What does this mean for American manufacturers? Consider that the total U.S. consumption of specialty steel decreased 11.5 percent between June 2007 and June 2008, but the percentage of foreign steel-known as the import penetration-actually increased from 35.6 percent to 39.9 percent. At the same time, U.S. steel exports dropped.
The primary increase stems from the importation of stainless steel sheet/strip, which has jumped 13.4 percent despite the fact that the nation's total consumption went down.
"Stainless steel imports of sheet and strip products continue to surge, even in the midst of a 10 percent decline in U.S. consumption," said Doug Kittenbrink, chairman of the Specialty Steel Industry of North America. "Currency manipulation and other subsidies are enabling Asian competitors to unfairly target our markets. We strongly believe it is time for the U.S. Congress to address the issue of China currency manipulation."
Many Americans concerned about the country's economy-as well as their own-are calling on the new Congress to enact legislation to help level the playing field for the nation's steel manufacturers. You can reach your senators at www.senate.gov and your representatives at www.house.gov. For additional information, visit www.ssina.com.
Steel may be considered the fabric of America, but much of it is coming from overseas.
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Thursday, November 06, 2008
FDA Seizes Contaminated Heparin from a Cincinnati Manufacturer
As part of the U.S. Food and Drug Administration's ongoing efforts to ensure that heparin for patients remains safe, the government today seized 11 lots of heparin from Celsus Laboratories Inc. in Cincinnati, Ohio.
The five lots of Heparin Sodium Active Pharmaceutical Ingredient (API) and six lots of Heparin Lithium were seized at the FDA's request by U.S. Marshals. These products, which were manufactured from material imported from China, had been found by the agency to be contaminated with over-sulfated chondroitin sulfate (OSCS), a substance that mimics heparin's anticoagulant activity.
“This action will help prevent this contaminated heparin from finding its way into the marketplace," said Mike Chappell, acting associate commissioner for regulatory affairs, FDA.
Heparin is a blood-thinning drug. An API is a substance or mixture of substances that, when delivered in a finished drug product, directly affects the structure or function of the body. Heparin Sodium USP is an API that may be incorporated into finished drug products. Heparin Lithium is used in certain medical devices including vacutainer blood collection tubes, some in vitro diagnostic assays, and as a coating for capillary tubes. Celsus has distributed Heparin Sodium USP and Heparin Lithium to manufacturers in both the United States and abroad.
OSCS contaminant in injectable drug products containing heparin has been linked to multiple adverse events and deaths initially reported to the FDA in January 2008. Since then, the FDA has put in place a comprehensive inspection and import controls program and has acted to remove from the market heparin materials and products contaminated with OSCS. The seized Celsus heparin – which had entered the United States before the establishment of import controls for the drug – was tested for the presence of OSCS as part of this FDA effort.
To date, the agency has initiated 13 recalls of multiple contaminated medical products containing heparin from several companies.
The FDA informed Celsus Laboratories during an April 2008 inspection and again in a May 8, 2008, letter that the company's actions to notify customers about a contaminant in its heparin were insufficient to assure an effective recall. The agency advises manufacturers who may have purchased heparin from Celsus to contact the company to make certain they are not using any heparin from the seized lots because the product does not meet acceptable quality standards.
The FDA has notified Japanese, Canadian, Australian, European Union, and other international authorities of shipments of contaminated heparin from Celsus.
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Friday, October 31, 2008
Everlasting Distributors Inc. Issues a Nationwide Recall of Fresh and Crispy Jacobina Biscuits Because of Possible Health Risks
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.
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Monday, October 06, 2008
FDA Detects Melamine Contamination in Flavored Drink
The U.S. Food and Drug Administration (FDA) has increased inspections and product testing efforts in response to the melamine contamination problem which originated in Chinese dairy products. As a result of the FDA’s on-going testing program, the agency has detected melamine contamination in Blue Cat Flavor Drinks. The distributor of the product, Tristar Food Wholesale Co. Inc., initiated a recall of several flavors of Blue Cat Flavor Drink, based on the FDA’s findings. The FDA advises the public not to consume this product and recommends that retailers and food service operators remove the product from sale or service.
Other Recalls
On September 26, the FDA issued an alert to consumers that seven Mr. Brown instant coffee and milk tea products were being recalled by the Taiwanese company, King Car Food Industrial Co. Ltd., due to possible contamination with melamine. King Car Food Industrial Co. used a non-dairy creamer manufactured by Shandong Duqing Inc., China, which was found to be contaminated with melamine. The recalled products are:
* Mr. Brown Mandheling Blend Instant Coffee (3-in-1)
* Mr. Brown Arabica Instant Coffee (3-in-1)
* Mr. Brown Blue Mountain Blend Instant Coffee (3-in-1)
* Mr. Brown Caramel Macchiato Instant Coffee (3-in-1)
* Mr. Brown French Vanilla Instant Coffee (3-in-1)
* Mr. Brown Mandhling Blend instant Coffee (2-in-1)
* Mr. Brown Milk Tea (3-in-1)
The FDA recommends that consumers not consume any of the above Mr. Brown instant coffee and milk tea products. The FDA also recommends that retailers and foodservice operators remove the products from sale or service.
Sunny Maid Corp. Monterey Park, Calif., who is an importer and distributor of Mr. Brown Instant Coffee products, is recalling the products in the United States.
The FDA is working with regulatory agencies in the United States as well as with other countries. The California Department of Public Health and the New Zealand Food Safety Authority reported that its testing of White Rabbit Creamy Candies has shown melamine contamination at high levels. In light of the widespread contamination of milk and milk-based products in China and the New Zealand Food Safety Authority’s finding, the FDA continues to recommend that consumers not eat White Rabbit Creamy Candy and that retailers and foodservice operations remove the product from sale or service.
A recall by QFCO Inc., Burlingame, Calif., of the White Rabbit Creamy Candies, is underway in the United States.
The FDA is closely monitoring these recalls and will continue to perform follow up activities of other recalls that may develop.
To date, the FDA is not aware of any illnesses in the United States stemming from consumption of Blue Cat Flavor Drinks, White Rabbit Creamy Candy, or the Mr. Brown instant coffee and milk tea products.
Individuals who have experienced any health problems after consuming Blue Cat Flavor Drinks, White Rabbit Creamy Candy, or any of the identified Mr. Brown coffee and tea products are advised to contact their health care professional.
Background
On September 12, 2008, in light of reports from China of melamine contaminated infant formula, the FDA issued a Health Information Advisory to assure the American public that there is no known threat of contamination in infant formula manufactured by companies that have met the requirements to sell such products in the United States. That advisory also warned members of Chinese communities in the United States that infant formula manufactured in China, possibly available for purchase at Asian markets, could pose a risk to infants.
The FDA had contacted the companies who manufacture infant formula for distribution in the United States and received, from the companies, information that they are not importing formula or sourcing milk-based materials from China.
At the same time, the FDA—in conjunction with state and local officials—began a nation-wide investigation to check Asian markets for Chinese manufactured infant formula that may have been brought into the United States. In particular, this effort focused on areas of the country with large Chinese communities, such as Los Angeles, San Francisco, Seattle and New York. To date, investigators have visited more than 1,800 retail markets and have not found Chinese infant formula present on shelves in these markets.
The FDA also advises consumers not to purchase infant formula manufactured in China from Internet sites or from other sources.
The FDA has taken, and will continue to take, proactive measures to help ensure the safety of the American food supply. In conjunction with state and local officials, the FDA will continue to visit Asian markets for food items that are imported from China and that could contain a significant amount of milk or milk proteins. In addition, the FDA has broadened its domestic and import sampling and testing of milk-derived ingredients and finished food products containing milk, such as candies, desserts, and beverages that could contain these ingredients from Chinese sources. Milk-derived ingredients include whole milk powder, non-fat milk powder, whey powder, lactose powder, and casein.
In addition to state and local governments, the FDA is working in close cooperation with Customs and Border Protection within the U.S. Department of Homeland Security, the U.S. Department of Agriculture, Centers for Disease Control and Prevention, other federal agencies, and foreign governments.
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Friday, September 26, 2008
FDA Updates Health Information Advisory on Melamine Contamination
The U.S. Food and Drug Administration (FDA) is alerting consumers that seven Mr. Brown instant coffee and milk tea products manufactured in China are being recalled by the King Car Food Industrial Co. Ltd. due to possible contamination with melamine. The products, manufactured by China’s Shandong Duqing Inc., are:
* Mr. Brown Mandheling Blend Instant Coffee (3-in-1)
* Mr. Brown Arabica Instant Coffee (3-in-1)
* Mr. Brown Blue Mountain Blend Instant Coffee (3-in-1)
* Mr. Brown Caramel Macchiato Instant Coffee (3-in-1)
* Mr. Brown French Vanilla Instant Coffee (3-in-1)
* Mr. Brown Mandhling Blend instant Coffee (2-in-1)
* Mr. Brown Milk Tea (3-in-1)
The FDA recommends that consumers not consume any of the above Mr. Brown instant coffee and milk tea products. The FDA also recommends that retailers and foodservice operators remove the products from sale or service.
As of September 25, 2008, the FDA testing of milk based products imported into the United States from China has not found melamine contamination.
The FDA is working with regulatory agencies in other countries. The New Zealand Food Safety Authority reports that its testing of White Rabbit Creamy Candies has shown melamine contamination at high levels. In light of the widespread contamination of milk and milk-based products in China and the New Zealand Food Safety Authority’s finding, the FDA recommends that consumers not eat White Rabbit Creamy Candy and that retailers and foodservice operations remove the product from sale or service.
To date, the FDA is not aware of any illnesses in the United States stemming from consumption of either White Rabbit Creamy Candy or the Mr. Brown instant coffee and milk tea products.
Individuals who have experienced any health problems after consuming either White Rabbit Creamy Candy or any of the identified Mr. Brown coffee and tea products are advised to contact their health care professional.
Background
On September 12, 2008, in light of reports from China of melamine contaminated infant formula, the FDA issued a Health Information Advisory to assure the American public that there is no known threat of contamination in infant formula manufactured by companies that have met the requirements to sell such products in the United States. That advisory also warned members of Chinese communities in the United States that infant formula manufactured in China, possibly available for purchase at Asian markets, could pose a risk to infants.
The FDA had contacted the companies who manufacture infant formula for distribution in the United States and received, from the companies, information that they are not importing formula or sourcing milk-based materials from China.
At the same time, the FDA—in conjunction with state and local officials—began a nation-wide investigation to check Asian markets for Chinese manufactured infant formula that may have been brought into the United States. In particular, this effort focused on areas of the country with large Chinese communities, such as Los Angeles, San Francisco, Seattle and New York. To date, investigators have visited more than 1,400 retail markets and have not found Chinese infant formula present on shelves in these markets.
The FDA also advises consumers not to purchase infant formula manufactured in China from Internet sites or from other sources.
The FDA has taken, and will continue to take, proactive measures to help ensure the safety of the American food supply. In conjunction with state and local officials, the FDA will continue to check Asian markets for food items that are imported from China and that could contain a significant amount of milk or milk proteins. In addition, the FDA has broadened its domestic and import sampling and testing of milk-derived ingredients and finished food products containing milk, such as candies, desserts, and beverages that could contain these ingredients from Chinese sources. Milk-derived ingredients include whole milk powder, non-fat milk powder, whey powder, lactose powder, and casein.
In addition to state and local governments, the FDA is working in close cooperation with Customs and Border Protection within the U.S. Department of Homeland Security, the U.S. Department of Agriculture, other federal agencies, and foreign governments.
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Monday, September 22, 2008
Compromised US and Chinese Computers Launch Greatest Number of Cyber Attacks, According to SecureWorks' Data
This was followed by Brazil with over 166,987 attempted attacks, South Korea with 162,289, Poland with 153,205, Japan with 142,346, Russia with 130,572, Taiwan with 124,997, Germany with 110,493, and Canada with 107,483.
"We believe these statistics are significant because it clearly shows that the United States and China have a lot of vulnerable computers that have been compromised and are being used as bots to launch cyber attacks," said Hunter King, security researcher for SecureWorks. "This should be a warning to organizations and personal computer users that, not only are they putting their computers and networks at risk by not securing them, but they are actually providing these cyber criminals with a platform from which to compromise other computers."
Computer security can be greatly improved by keeping your web browser and operating system up to date, using the latest versions of antivirus and antispyware software, following safe computer practices such as being wary of the websites you visit, and not clicking on attachments and links within emails until verifying that the sender intentionally sent the enclosed link or attachment."
"These findings illustrate the ineffectiveness of simply blocking incoming communications from foreign IP addresses as a way to defend your organization from cyber attacks, as many hackers hijack computers outside their borders to attack their victims," said Don Jackson, Director of Threat Intelligence for SecureWorks. "The Georgia/Russia cyber conflict was a perfect example of this. Many of the Georgian IT staff members thought that by blocking Russian IP addresses they would be able to protect their networks, however, many of the Russian attacks were actually launched from IP addresses in Turkey and the United States so consequently they were hit hard. This was a perfect example where we saw Russian cyber criminals using compromised computers outside their borders."
"On the other hand, we have found that many of the Chinese hackers will compromise large networks within their own country and use them as bots to attack other organizations," continued Jackson. "For example, entire university networks in China will belong to local hacker groups."
"China's hackers do create botnets from spamming through email and blogs, but a relatively larger percentage of the compromised hosts under Chinese control are simply machines in schools, data centers, companies -- in other words, on large networks -- that are mostly unguarded and consequently are entirely controlled by hacker groups, as opposed to distributed bots harvested from widely distributed international spam runs, said Jackson. "And often the groups have an insider in the networks they own. We also see many local hacker groups in Japan and Poland compromise hosts within their own country to use in cyber attacks, so the Chinese hackers are not alone in using resources within their own borders."
With hackers utilizing computer resources inside and outside of their borders, SecureWorks suggests that in addition to securing computers with ongoing system and security updates and patches, organizations should utilize a black list to block inbound communications from known malicious IP addresses. Organizations should also block outbound communications to foreign countries known to harbor hackers and block outbound communications to hostile networks known to host criminal activity. This way if your organization does have an infected host within its network, then the host will be blocked from sending personal or company data to the cyber criminals. Of course, some of these hostile networks do support a handful of legitimate sites. In addition to a blacklist, your organization can use a separate whitelist to allow outbound communication only to trustworthy sites on those otherwise hostile networks.
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Friday, September 12, 2008
Health Alert in Chinese Manufactured Infant Formula
In response to reports of contaminated milk-based infant formula manufactured in China, the U.S. Food and Drug Administration (FDA) today is issuing a Health Information Advisory. This is to assure the American public that there is no known threat of contamination in infant formula manufactured by companies that have met the requirements to sell infant formula in the United States. Although no Chinese manufacturers of infant formula have fulfilled the requirements to sell infant formula in the United States, FDA officials are investigating whether or not infant formula manufactured in China is being sold in specialty markets which serve the Asian community.
The FDA is advising caregivers not to feed infant formula manufactured in China to infants. This should be replaced with an appropriate infant formula manufactured in the United States as mentioned below. Individuals should contact their health care professional if they have questions regarding their infant’s health or if they note changes in their infant’s health status.
The FDA began investigating the reports of contamination immediately and received information from the companies who manufacture infant formula for the American market that they are not importing infant formula or source materials from China. The following manufacturers have met the necessary FDA requirements for marketing milk-based infant formulas in the United States: Abbott Nutritionals, Mead Johnson Nutritionals, Nestle USA, PBM Nutritionals, and Solus Products LLC. Also, one manufacturer, SHS/Nutricia, Liverpool, England, markets an amino acid based exempt infant formula that does not contain any milk-derived ingredients.
We are asking state officials to work with the Agency to assist with the removal of any Chinese infant formula found on store shelves, and to warn members of the Asian community to avoid using Chinese manufactured infant formula.
It has been reported that a number of infants in China who have consumed Chinese manufactured infant formula are suffering from kidney stones, a condition which is rare in infants. The Chinese manufactured infant formula may be contaminated with melamine. Melamine artificially increases the protein profile of milk and can causes kidney diseases such as those seen in these Chinese infants.
FDA requires that all infant formula manufacturers register with the Agency and adhere to specific labeling and nutritional requirements. All properly registered infant formula manufacturers marketing infant formula in the United States undergo an annual inspection of their production facilities.
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Monday, June 23, 2008
Coming Soon: Generic Drugs from China
If you liked the heparin, dog food, lead-painted toys, toothpaste and truck tires from China, you'll be happy to hear that Chinese-made generic drugs are making their way to the U.S. While the development raises some safety concerns....
Read the story.
Saturday, January 12, 2008
China, lead and coal mines
In my toxic note on the subject I tossed out the possibility that they were out to get us... Who needs nuclear weapons when you can poison the kids and destroy the economy? Destroy the economy you say??? It's killing some of these companies to have to recall all the toys and other products.
Today a news story floated across my screen (posted below) that stated China had the worst record in the world for deaths in coal mines. I had thought all the lead based paints on toys and products from China might be happening due to the low cost of paint (maybe they bought all our rejects) or, as said earlier, a desire to cripple the U.S.
Now I'm thinking this through a little deeper. I know they have a large population in China. Maybe human life doesn't have a high enough value in China (by my standards).
All those people who are involved in painting our lead covered toys are being exposed on a much higher level than our kids. Expendable? Lower caste? Lead soaked brains make happy drones?
If they didn't make so many of our products it would be easier to boycott China-made. But that begs a bigger question. If we're not buying then where do the factory workers in China go? If life is bad for them now, and it must be horrific if they're breathing and touching lead all day, then what would it be like on the streets?
I think we need to toughen up our standards and figure out a way to enforce them. Big money involved in enforcement.
See how easy it is to get off on a tangent? I start writing about life and end up on enforcing regulations.
It would be interesting to do some comparative stats between life in America vs. life in China. Quality, life expectancy and other comparisons could tell an interesting story. Maybe I'll add that to my list of things to do someday.
Here's the story:
China's coal mines kill 3,786 in 2007
BEIJING - Accidents in China's notoriously dangerous coal mines killed nearly 3,800 people last year, state media reported Saturday — a toll that is a marked improvement from previous years, but still leaves China's mines the world's deadliest.
http://news.yahoo.com/s/ap/20080112/ap_on_re_as/china_deadly_mines
Friday, December 28, 2007
North American Breaker Co. Recalls Counterfeit Circuit Breakers Due to Fire Hazard
Name of Product: Counterfeit Circuit Breakers labeled as "Square D"
Units: About 50,000
Distributor/Retailer: North American Breaker Co. Inc. (NABCO), of Burbank, Calif.
Hazard: The recalled circuit breakers labeled "Square D" have been determined by Square D to be counterfeit and can fail to trip when they are overloaded, posing a fire hazard to consumers.
Incidents/Injuries: None reported.
Description: The counterfeit circuit breakers are black and are labeled as Square D QO-series models 110, 115, 120, 130, 210, 215, 220, 225, 230, 235, 240, 250, 260, 280, 1515, 1520, 2020, 2125, 315, 340, 350, 360, and 3100. Actual Square D circuit breakers have (a) the amp rating written on the handle in white paint on the front of the breaker; (b) the Square D insignia molded onto the breaker side, and; (c) a yellow chromate mounting clip with half of the top of the clip visible. If your breaker, labeled as Square D, does not match this description, it could be counterfeit.
Sold by: NABCO, electrical distributors, and retailers nationwide from March 2003 through April 2006 for between $3 and $85.
Manufactured in: China
Remedy: Consumers should contact NABCO to determine if the breaker they have is counterfeit and to arrange for a free inspection and replacement or refund if necessary.
Consumer Contact: For additional information, contact NABCO at (866) 505-5851 from 8 a.m. to 5 p.m. PT, email the firm at recall@nabreaker.com, or visit the firm's Web site atwww.nabcorecall.com - this is not a Square D Company recall.
Tot Tower Blocks Recalled by eeBoo Corp.; Children's Toy Can PoseChoking Hazard
Consumers should stop using recalled products immediately unless otherwise instructed.
Name of Product: Tot Tower toy blocks
Units: About 170,000
Importer: eeBoo Corp., of New York, N.Y.
Hazard: The plastic covering on the toy blocks can detach, posing a choking hazard to children.
Incidents/Injuries: The firm has received two reports of the plastic covering detaching from the blocks and being mouthed by young children.
No injuries have been reported.
Description: The recalled Tot Tower blocks are sold in sets of 10 blocks ranging from 6 x 6 inches to 1.5 x 1.5 inches. The cardboard blocks are covered in a plastic laminate film. The blocks have various images and themes including Things I Know New; Garden Fairies; Hardware Store; Around the Land; Read-To-Me; Animal Sounds; Animal Alphabet; ABC; and Nursery Friends. "Tot Towers" and "eeBoo Corporation" are printed on the product's packaging.
Sold at: Specialty and gift shops nationwide from January 2003 through September 2007 for about $20.
Manufactured in: China
Remedy: Consumers should immediately take the recalled toy away from children, and return it to the place of purchase for a full refund, or contact eeBoo Corp. directly to receive a replacement toy.
Consumer Contact: For additional information, contact eeBoo Corp. at (800) 791-5619 between 9 a.m. and 4 p.m. ET Monday through Friday, or visit the firm's Web site at www.eeboo.com
FDA Warns Consumers Not to Use Super Shangai, Strong Testis, Shangai Ultra, Shangai Ultra X, Lady Shangai, and Shangai Regular (also known as Shangai
These products are illegal drugs and contain undeclared active ingredients in prescription erectile dysfunction drugs
The U.S. Food and Drug Administration (FDA) is advising consumers not to buy or use Super Shangai, Strong Testis, Shangai Ultra, Shangai Ultra X, Lady Shangai, and Shangai Regular, also marketed as Shangai Chaojimengnan, products.
These products, which originate in China, are being marketed for the treatment of erectile dysfunction (ED) and for sexual enhancement. Although labeled as dietary supplements, these products do not qualify as dietary supplements because they contain undeclared active ingredients of FDA-approved prescription drugs for erectile dysfunction. The products are thus drugs that are illegal because they lack FDA approval.
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.
"Products like these put consumers at considerable risk because they contain undeclared active ingredients in FDA approved drugs that require a prescription to obtain," said Janet Woodcock, M.D., FDA's deputy commissioner for scientific and medical programs, chief medical officer, and acting director of the Center for Drug Evaluation and Research (CDER). "An unsuspecting consumer with underlying medical issues may buy and take these products without knowing that they can cause serious drug interactions."
FDA performed chemical testing of the products that revealed that Super Shangai, Strong Testis, Shangai Ultra, Shangai Ultra X, and Lady Shangai contain sildenafil, the active ingredient in Viagra, an FDA-approved drug for erectile dysfunction. Shangai Regular, also marketed as Shangai Chaojimengnan, contains an unapproved substance with a structure similar to sildenafil that may cause similar side effects and drug interactions. Neither sildenafil nor the analog of sildenafil is listed as an ingredient on the label of any of these products.
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 feel 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 should 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 products are packaged and distributed by Shangai Distributor, Inc. of Coamo, Puerto Rico.