Recall Roundup: July 2008

Wednesday, July 30, 2008

Federal Agents Seize more than $24 Million in Unapproved New Drugs

Representatives of the U.S. Food and Drug Administration and the U.S. Marshals Service today seized $24.2 million worth of unapproved new drugs from KV Pharmaceutical Company of St. Louis, Mo. Agents acted after United States Attorney Catherine L. Hanaway filed a civil forfeiture suit and obtained a warrant to seize the unapproved new drug products being made by KV Pharmaceutical.

"American consumers are entitled to have safe and effective drugs," said Hanaway.

The seizure followed an inspection of several of the company's plants where FDA investigators found that the company was not complying with an FDA enforcement notice as well as manufacturing unapproved new drugs such as products for cough, cold, topical wound healing, skin bleaching, and gastrointestinal conditions, as well as narcotic drug products.

"The FDA is committed to taking enforcement action against firms that circumvent the drug approval process," said Janet Woodcock, M.D., director of FDA's Center for Drug Evaluation and Research (CDER). "Consumers need to be confident that the drugs and medical products they use are safe and effective, and the FDA will take the necessary measures to ensure safety and effectiveness throughout the lifecycle of the product, including keeping the product from reaching the marketplace."

In a routine inspection of KV Pharmaceutical's facilities in early 2008, the FDA found the company was violating its May 29, 2007, notice (72 FR 29517) requiring companies to stop manufacturing all timed-release drug products containing guaifenesin, including combination drug products in which guaifenesin is in immediate release form, but another ingredient in the combination drug product is in timed-release form, because they are unapproved new drugs. FDA took the action as part of its effort to ensure that all drugs marketed in the United States have the required FDA approval and that they are safe, effective, of good quality, and are appropriately labeled. For products in timed-release form, FDA approval is also necessary to make sure that the product releases its active ingredients at the correct rate. Improperly manufactured timed-release products may release the active ingredients too quickly, too slowly, or not at all, making the product unsafe or ineffective.

The FDA required companies to stop manufacturing the affected products before August 27, 2007, and to stop shipping the products before November 26, 2007. KV Pharmaceutical continued to manufacture and ship these unapproved new drugs after the cessation dates.

The inspection also exposed the company's manufacturing and distribution of other unapproved drug products. Today's action addresses numerous unapproved drug products manufactured and distributed by the company.

The following drug products were seized and will be destroyed:

PhenaVent Capsules
PhenaVent LA Capsules
PhenaVent PED Capsules
Ethezyme Papain-Urea Ointment
Ethezyme 650 Papain-Urea Ointment
Ethezyme 830 Papain-Urea Ointment
Hista-Vent DA Tablets
Meperidine/Promethazine Capsules
Pseudovent Capsules
Pseudovent 400 Capsules
Pseudovent PED Capsules
Tri-Vent DM Syrup
Tri-Vent DPC Syrup
Hydro-Tussin DM Liquid
Hydro-Tussin CBX Syrup
Hydro-Tussin DHC Syrup
Hydro- Tussin EXP Syrup
Hydro-Tussin HD Syrup
Hyoscyamine Sulfate Sublingual Tablets
Hydroquinone 4% Cream
Hydroquinone 4% Cream with Sunscreen
Bromfenex Extended Release Capsules
Bromfenex PD Extended Release Capsules

The seized drugs had been held under embargo by the state of Missouri. Since the time of the embargo, KV Pharmaceutical has been cooperating with FDA officials.

"The FDA will take action against companies that continue to manufacture or market an unapproved product after the marketing or distribution cessation date," said Deborah M. Autor, director of the FDA's Office of Compliance within CDER. "When a company does not heed a cessation date relating to a specific product, the FDA will take enforcement action relating to the company's other unapproved drugs."

In June 2006, the FDA issued a guidance document titled, "Marketed Unapproved Drugs—Compliance Policy Guide (CPG)." This CPG makes clear that companies may not market drugs that require approval without first establishing, through applications for approval, that the products are safe and effective.

The FDA encourages consumers who may have these products to contact their health care professional about FDA-approved treatments and discard these products.

Tuesday, July 29, 2008

Wooden Toys Recalled by Earthentree Due To Choking and Strangulation Hazards

New England Ropes Recalls Climbing Lines Due to Fall Hazard

EG Labs Announces Urgent Nationwide Voluntary Recall of ALL LOTS of Viapro 375 mg Capsules, due to a Potentially Harmful Ingredient

EG Labs, LLC, announced today that it is conducting a nationwide voluntary recall of all lots of its supplement product sold under the brand name, Viapro, in 375mg capsules. EG Labs, LLC. is conducting this recall after being informed by representatives of the Food and Drug Administration (FDA) that lab analysis by FDA of a sample from one lot of the product revealed that it contained a potentially harmful undeclared ingredient, thio-methisosildenafil. FDA asserts that this ingredient is an analog of sildenafil. Sildenafil is the active chemical ingredient of an FDA-approved drug used for Erectile Dysfunction (ED) in men to enhance sexual performance.

The use of undeclared chemicals pose a threat to consumers because they may harmfully interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take such nitrates.

Viapro capsules were sold in retail outlets nationwide and were packaged into 2-capsule blister, 1 capsule blister and 10 capsule bottles. Viapro has not been sold since about March 2008.

Customers who have this product in their possession should stop using it immediately and contact their physician if they have experienced any problems that may be related to taking this product. Please return the product for a full refund to the address below.

Seaboard Tampa Terminal: 6708 Harney Road Tampa Florida, 33610

Any adverse events that may be related to the use of this product should be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088 or by fax at 1-800-FDA-0178 or by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or online.

Monday, July 28, 2008

Vita Food Products Issues Alert Regarding Vita Nova Salmon

Vita Food Products Issues Alert Regarding Vita Nova Salmon
Code Date of 11/16/08 198, Purchased on July 22 or After

Vita Food Products, Inc. of Chicago, Illinois is notifying the public that twelve individual packages of Vita Nova Salmon, were sold at Kroger stores in Houston, Texas on or after July 22 of this year may be contaminated with Listeria monocytogenes. In addition, 192 individual packages of this same product have either possibly been sold or are being offered for sale at various grocery stores in the Avenol, New Jersey metropolitan area. To date, no confirmed illnesses or complaints have been reported by customers , although the Company is closely monitoring the situation.

The product that is the subject of this public announcement and recall are packages (deep dark blue in color) of smoked salmon that bear the Vita logo in the upper left corner on the part of the packaging that is immediately visible to the consumer. Each package contains 4-10 bacon-style slices (total 3 oz.) of smoked salmon; the slices are contained in a vacuum pack within a box that is 4" wide by 7.5 " in length by 1/2 " in thickness. IMPORTANT: The Code Date of 11/16/08 198 is on the left end flap of each package. This announcement and recall only applies to packages that bear that CODE DATE.

Listeria monocytogenes is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. 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.

If any consumer purchased a product with that CODE DATE from a retail store on or after July 22, 2008 he or she should not consume any of the Vita Nova Salmon product. Then, the Company asks that it be sealed in plastic bag or placed in some similar container and returned to the retailer from which it was purchased. The Company is asking that any person who has purchased the product with this CODE DATE call this telephone number 1-800-989-8482 . If you are experiencing any unusual or severe symptoms such as those described above, go to an emergency room immediately or contact your physician for immediate advice.

Jack Distribution, LLC. Issues a Voluntary Nationwide Recall of all Lots of Rize 2 The Occasion Capsules and Rose 4 Her Capsules

Jack Distribution, LLC. Issues a Voluntary Nationwide Recall of all Lots of Rize 2 The Occasion Capsules and Rose 4 Her Capsules, Products Marketed as Dietary Supplements, Containing an Undeclared Ingredient

Jack Distribution, LLC, 1501 Green Road Unit C Pompano Beach, Florida 33064 and its wholesale distributors G & N works, Inc., and Devine Distribution, Inc., announced today that they are conducting a voluntary nationwide recall of all lot numbers of the company's supplement products sold under the brand names Rize 2 The Occasion and Rose 4 Her. New lots of Rize 2 and Rose 4 her (not subject to this recall) will contain lot numbers beginning in "BL".

Jack Distribution, LLC, is conducting this recall after being informed by representatives of the Food and Drug Administration (FDA) that lab analysis by FDA of Rize 2 and Rose 4 Her samples of random lots found the product contains potentially harmful, undeclared ingredients. FDA asserts that its chemical analysis revealed that Rize 2 The Occasion and Rose 4 Her contain thiomethisosildenafil, an analog of sildenafil, the active ingredient of a FDA-approved drug used for Erectile Dysfunction (ED). FDA maintains that this ingredient is close in structure to sildenafil and is expected to possess a similar pharmacological and adverse event profile. This undeclared chemical poses a potential threat to consumers because it may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels.

Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. ED is a common problem in men with these conditions, and consumers may seek these types of products to enhance sexual performance.

Customers who have this product in their possession should stop using it immediately and contact their physician if they have experienced any problems that may be related to taking this product.

Any adverse events that may be related to the use of this product should be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088 or by fax at 1-800-FDA-0178 or by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787.

The company advises that any unused portions can be returned to the place of purchase for a full refund of purchase price. Jack Distribution will manufacture new lots of these products which are not subject to the recall. Those lot numbers will begin with "BL" and will begin to be sold shortly.

Rize 2 and Rose 4 Her are sold in adult stores, vitamin & nutrition shops, convenience stores, and via the internet nationwide. The Rize 2 product is sold as a (single blister pack, three count bottles, twelve count bottles, and thirty count bottles. Rose 4 Her is only available in single blister packs and three count bottles.

The Company is taking this voluntary action because it is committed and is always concerned with the health of persons who have consumed this product. The Company is reviewing the procedures and policies of all firms involved with the manufacture of the product to ensure that there will be no future issues with regard to Rize 2 and Rose 4 Her pills composition. The Company is working closely with the FDA in the recall process and is committed to the quality and integrity of its products. It sincerely regrets any inconvenience to consumers and its other customers.

Pacific Science Supplies Recalls Magnets Due to Violation of Lead Paint Standard

Horseshoe Magnets Recalled by Dowling Magnets Due to Violation of Lead Paint Standard

Kids II Recalls Infant Rattles Due to Choking Hazard

Cost Plus Recalls Santorini Chairs Due to Fall Hazard

Remote-Controlled Helicopter Toys Recalled by Innovage Due to Fire and Burn Hazards

Reebok International Ltd. Recalls Exercise Cycles Due to Laceration Hazard

Sau-Sea Foods, Inc. Issues Allergy Alert on Undeclared Egg in Smoked Salmon Spread in 7.5 Ounce Plastic Tub With Snap Lid

Sau-Sea foods, Inc, of Water Mill NY is recalling all tubs of SMOKED SALMON Spread with the sell by dates as follows: 072308, 082708, 092408, 1 12508, 03 1309. People who have an allergy or severe sensitivity to egg run the risk of serious or life threatening allergic reaction if they consume these products.

SMOKED SALMON SPREAD was distributed throughout the Northeast through retail stores.

The SMOKED SALMON SPREAD comes in 3 7.5 ounce, semi rigged plastic tub with a snap on lid and was sold under the name Sau-Sea.

The recall was initiated after it was discovered that the Smoked Salmon Spread containing egg was distributed in packaging that did not reveal the presence of egg. Subsequent investigation indicates the problem was caused by an oversight in the company's development process.

Consumers who have purchased these products are urged to return it to the location of purchase for a full refund. Consumers with questions may contact the company at 1-631-726-0269.

No illnesses have been reported to date.

The Food and Drug Administration has been notified of the voluntary recall.

Federal Authorities Seize Xiadafil VIP Tablets After Company Refuses to Recall Product

At the request of the U.S. Food and Drug Administration, U.S. Marshals seized nearly $74,000 worth of Xiadafil VIP tablets, Lots 6K029 and 6K209-SEI, distributed by SEI Pharmaceuticals, Inc. of Miami, Fla. Although marketed as a dietary supplement to treat erectile dysfunction (ED) and for sexual enhancement, these lots represent an illegally marketed drug containing an undeclared ingredient.

Today's action follows a formal FDA request to SEI Pharmaceuticals (SEI) on May 27, 2008, to recall the lots of Xiadafil VIP tablets. The products were given away at trade shows and sold in eight tablet bottles (Lot # 6K029) and blister cards of two tablets (Lot # 6K029-SEI) bearing an expiration date of September 2009 (09/09). The company, however, refused to recall these products, making the seizure action necessary to prevent additional, illegal Xiadafil VIP products from entering the marketplace.

The FDA's chemical analysis of Xiadafil VIP tablets Lots # 6K029/6K029-SEI found that the product contains hydroxyhomosildenafil, which is chemically similar to sildenafil. Sildenafil is the active ingredient in Viagra, an FDA-approved prescription drug for ED. The FDA has not approved Xiadafil VIP for ED or any other drug use, and the safety and effectiveness of this product is unknown. Although offered for sale as dietary supplements, the seized articles are new drugs that may not be introduced into interstate commerce without an approved new drug application filed with FDA.

"Today's seizure action shows that FDA will take enforcement action to protect the public from dietary supplements that contain prescription drug ingredients that are potentially harmful to consumers," said Margaret O'K Glavin, associate commissioner of the FDA's Office of Regulatory Affairs. "FDA will not tolerate a company's failure to take voluntary action to protect the public health after being given the opportunity by FDA to do so," she added.

On April 22, 2008, the FDA initiated an inspection at SEI Pharmaceuticals following its analysis of the Xiadafil VIP tablets. The company was advised of the FDA's findings and informed of the potential adverse health risks the product posed to unsuspecting consumers. The FDA also warned the company of possible legal actions, including seizure and/or injunction if corrective and preventive actions were not implemented. Although the company committed to halting distribution of the product and deactivated its Internet site, it refused to recall the product already in the market.

On May 13, 2008, Florida state officials issued a "stop sale" action at SEI's distribution facility to keep the illegal product out of the marketplace. This action required SEI to hold, intact, violative Xiadafil VIP tablets found at the facility.

ED is a common problem in men who have diabetes, high blood pressure, high cholesterol, or heart disease. Because they may have been advised against taking ED drugs, men with these conditions may seek alternative products like Xiadafil VIP tablets because they are marketed as "all natural" or as not containing the active ingredients in approved, prescribed ED drugs. Furthermore, because the manufacturing source of the active ingredients in many of these alternative products is unknown, consumers should also be aware that the safety, efficacy, and purity of these ingredients have not been verified by the FDA.

Consumers should discontinue the use of Xiadafil VIP tablets immediately and consult their health care professional if they have experienced adverse events that they believe may be related to the use of this product.

Consumers and health care professionals can report adverse events to the FDA's MedWatch program at 800-FDA-1088, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, Md 20852-9787, or online at www.fda.gov/medwatch/report.htm.

Publix Issues Recall for No Sugar Added Cherry Pie

Publix Super Markets is issuing a voluntary recall on three codes of No Sugar Added Cherry Pie with a sell-by-date of July 8 – July 27. UPC numbers for the affected product may be found on the back label below the Nutritional Facts panel:

* Publix NSA 8inch Cherry Pie, UPC: 41415-65990
* Publix NSA 1/2 Cherry Pie, UPC: 03000-00225
* Publix NSA 1/4 Cherry Pie, UPC: 41415-66990

These products were sold in the retail bakeries and were recalled due to the undeclared soy ingredient. People who have an allergy or severe sensitivity to soy run the risk of serious or life-threatening allergic reaction if they consume these products. The recall affected stores in Georgia, Alabama, South Carolina, Tennessee and Florida stores in Citrus County south through Monroe County, excluding Orlando proper stores.

"The packaging error was detected during a routine label review," said Maria Brous, Publix media and community relations director. "As part of our commitment to food safety, we routinely inspect our product labeling for accuracy and for product quality. There have been no reported cases of illness. Customers who have purchased the product may return it to their store for a full refund or replacement. Consumers with questions may contact Publix at 1-800-242-1227."

Tuesday, July 22, 2008

Electra Bicycle Company Recalls Amsterdam Bicycles; Chain Can Derail and Pose Injury Risk to Riders

It's MY Binky Recalls Personalized Pacifiers Due to Choking Hazard

Indoor Lighting Fixtures Recalled by Lithonia Lighting Due to Fire Hazard

Monday, July 21, 2008

Agricola Zaragoza, Inc. Recalls Jalapeno Peppers Because of Possible Health Risk

Agricola Zaragoza, Inc. of McAllen, TX is recalling Jalapeno Peppers distributed since June 30th, 2008 because they have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.

The Jalapeno Peppers were distributed to customers in GA and TX.

The Jalapeno Peppers being recalled were shipped in 35lb. plastic crates and in 50lb. bags with no brand name or label.

The recall is a result of sampling by FDA, which revealed that these Jalapeno Peppers were contaminated with the same strain of Salmonella Saintpaul responsible for the current Salmonella outbreak. It is unknown at this time which, if any, of the more than 1,200 illnesses reported to date are related to this particular product or to the grower who supplied this product. Distribution of these products has been suspended while FDA, the Texas Department of State Health Services and the company continue their investigation as to the source of the problem.

Consumers and retailers who purchased Jalapeno Peppers should contact their supplier to determine if their products are involved in the recall. Commercial manufacturers that have used these recalled Jalapeno Peppers as an ingredient in other products (i.e. salsas, etc.) are encouraged to contact their local FDA office to determine if these products should be recalled. Additionally, restaurants, retail food stores, and similar retail institutions that have used these Jalapeno Peppers as a garnish or as an ingredient to prepare entrees, salsas or other products are asked to dispose of these products making sure that all such peppers are not inadvertently made available for purchase, salvage or donation and therefore preventing any possibility for human or animal consumption.. Consumers with questions may contact the company at (956)-631-6405.

Domega International Co., Ltd. Issues an Alert on Undeclared Sulfites in Korica Brand Mut Gung Sweetened Ginger

DOMEGA INTERNATIONAL CO., LTD., 98 Bay 35th Street, Brooklyn, NY 11214 is recalling Korica Brand “Mut Gung” Sweetened Ginger because it contains undeclared sulfites. People who have severe sensitivity to sulfites run the risk of serious or life-threatening allergic reactions if they consume this product.

The recalled Korica Brand “Mut Gung Sweetened Ginger is sold in uncoded 7 oz plastic tubs and is a product of Vietnam. The product was sold nationwide.

The recall was initiated after routine sampling by New York State Department of Agriculture and Markets Food Inspectors and Subsequent analysis of the product by Food Laboratory personnel revealed the presence of sulfites in Korica Brand “Mut Gung” Sweetened Ginger in packages which did not declare sulfites 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.

No illnesses involving this product have been reported to date. Consumers who have purchased Korica Brand “Mut Gung Sweetened Ginger should return them to the place of purchase. Consumers with questions may contact the company at 646-938-7345.

Grande Produce, LTD.CO Recalls Jalapeno Peppers, Serrano Peppers, and Avocados Because of Possible Health Risk

FDA Note: "According to the Texas and North Carolina Departments of Health, the strain of Salmonella found in this company's jalapeño and serrano peppers and in its avocado is not Salmonella Saintpaul, and is not believed to be related to the current Salmonella outbreak.

The recall is a result of sampling not by the U.S. Food and Drug Administration (FDA) but by the Texas Department of State Health Services (Texas Health) and the North Carolina Department of Health and Human Services (North Carolina Health ) which revealed that these products contained the bacteria.

The company has voluntarily initiated a recall of its already distributed products and has stopped future distribution while the FDA, Texas Health, North Carolina Health and the company continue to investigate to determine the source of the problem."

Grande Produce, LTD. CO of Hidalgo, Texas (hereinafter referred to as Grande Produce) is recalling Jalepeno Peppers and Serrano Peppers distributed between May 17th and July 17th, 2008; and Avocados, all sizes, with lot #HUE08160090889 because they have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.

The Jalapeno Peppers, Serrano Peppers and Avocados were distributed to the following states: TX, DE, NC, GA, OK, IA, MN, IL, FL, IN, MD, NY, MS, AR, KS, and KY.

The avocados being recalled were shipped in boxes labeled "Frutas Finas de Tancitaro HASS Avocados, Produce of Mexico," all sizes, with lot number HUE08160090889. The Jalapeno Peppers and Serrano peppers being recalled were shipped in 35lb. plastic crates with no brand name or label.

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

The recall is a result of sampling by the Texas Department of State Health Services and The North Carolina Department of Health and Human Services, which revealed that these products contained the bacteria. Distribution of these products has been suspended while FDA, the Texas Department of State Health Services, The North Carolina Department of Health and Human Services and the company continue their investigation as to the source of the problem.

Consumers who purchased Avocados, Jalapeno Peppers and Serrano Peppers should contact their supplier to determine if their products are involved in the recall. Consumers with questions may contact the company at (956) 843-8575.

Friday, July 18, 2008

SunL Group Inc. Recalls Youth ATVs Due To Safety Defects

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: SLA90 Youth All-Terrain Vehicles (ATVs)

Units: About 144

Distributor: SunL Group Inc., of Irving, Texas

Hazard: The youth ATV lacks front brakes, a manual fuel shut-off, and padding to cover the sharp edges on the handlebar assembly. Additionally, the vehicle is sold without a tire pressure gauge or adequate flag pole bracket. The defects could lead to young drivers losing control of the ATVs, which poses the risk of serious injuries or death.

Incidents/Injuries: None.

Description: The recalled SLA90 ATVs are intended for children between the ages of 12 and 15 years old. The recalled SLA90 ATVs were available in the following solid colors: red, blue, yellow, green. The ATVs were available in the following camo colors: pink, brown, green, and blue. The word "Sunl" is on the front side of the ATV. The recalled units have one of the following Vehicle Identification Numbers:

TT05035366 TT05035376 TT05035386 TT05035396 TT05035406 TT05035416 TT05035426 TT05035436 TT05035446
TT05035367 TT05035377 TT05035387 TT05035397 TT05035407 TT05035417 TT05035427 TT05035437 TT05035447
TT05035368 TT05035378 TT05035388 TT05035398 TT05035408 TT05035418 TT05035428 TT05035438 TT05035448
TT05035369 TT05035379 TT05035389 TT05035399 TT05035409 TT05035419 TT05035429 TT05035439 TT05035449
TT05035370 TT05035380 TT05035390 TT05035400 TT05035410 TT05035420 TT05035430 TT05035440 TT05035450
TT05035371 TT05035381 TT05035391 TT05035401 TT05035411 TT05035421 TT05035431 TT05035441 TT05035451
TT05035372 TT05035382 TT05035392 TT05035402 TT05035412 TT05035422 TT05035432 TT05035442 TT05035452
TT05035373 TT05035383 TT05035393 TT05035403 TT05035413 TT05035423 TT05035433 TT05035443 TT05035453
TT05035374 TT05035384 TT05035394 TT05035404 TT05035414 TT05035424 TT05035434 TT05035444 TT05035454
TT05035375 TT05035385 TT05035395 TT05035405 TT05035415 TT05035425 TT05035435 TT05035445 TT05035455
TT05035456 TT05035463 TT05035470 TT05035477 TT05035484 TT05035491 TT05035498 TT05035505
TT05035457 TT05035464 TT05035471 TT05035478 TT05035485 TT05035492 TT05035499 TT05035506
TT05035458 TT05035465 TT05035472 TT05035479 TT05035486 TT05035493 TT05035500 TT05035507
TT05035459 TT05035466 TT05035473 TT05035480 TT05035487 TT05035494 TT05035501 TT05035508
TT05035460 TT05035467 TT05035474 TT05035481 TT05035488 TT05035495 TT05035502 TT05035509
TT05035461 TT05035468 TT05035475 TT05035482 TT05035489 TT05035496 TT05035503
TT05035462 TT05035469 TT05035476 TT05035483 TT05035490 TT05035497 TT05035504

Sold through: SunL Group dealers nationwide and Web retailers from May 2005 through March 2007 for between $400 and $500.

Manufactured in: China

Remedy: Consumers should immediately stop using these ATVs and contact SunL Group for instructions on how to receive a full refund.

Consumer Contact: Consumers can contact SunL Group toll-free at (866) 355-0497 between 9 a.m. and 6 p.m. CT Monday through Friday, or visit the firm's web site www.sunl.com

Thursday, July 17, 2008

Log Splitter Engines Recalled By American Honda Motor Co. Due to Fire Hazard

Studio RTA Recalls TV Stands Due to TV Tip-over Hazard

Wednesday, July 16, 2008

Roxane Laboratories, Inc. Initiates a Nationwide Voluntary Recall of Two Manufacturing Lots of Sodium Polystyrene Sulfonate Suspension in the US and P

Roxane Laboratories, Inc. announced today that it is conducting a nationwide voluntary recall of two manufacturing lots of Sodium Polystyrene Sulfonate Suspension, USP, 15 g/60 mL Unit dose bottles (NDC 0054-0165-51; Lot 856396A Exp April 2010, and Lot 856693A Exp May 2010). Sodium Polystyrene Sulfonate Suspension is used to treat hyperkalemia (an elevated blood level of the electrolyte potassium).

Roxane Laboratories' number one priority is for the safety of patients who use our products. A sample from product lot 856396A tested positive for a strain of yeast, which could potentially affect immunocompromised patients. Roxane Laboratories believes that this may be attributed to yeast contamination in one lot of high-density polyethylene bottles received from a supplier. There are various manifestations of yeast infections. The risk of developing a yeast infection depends on how immunocompromised the patient is. Additionally, there are a range of symptoms in a yeast infection from thrush, skin rash, and blood infections (sepsis). If patients develop an infection they should consult their physician. Due to the potential risks that could occur in immunocompromised patients, Roxane Laboratories is voluntarily recalling lot 856396A. Although there have been no testing failures associated with lot 856693A, this additional lot is also being included in the recall as a precautionary measure because the same lot of bottles was used in both finished product lots. All other product parameters were within specification and product efficacy is not impacted. There have been no complaints or adverse events reported for the affected lots. This recall is limited to the two lot numbers listed. No other Roxane Laboratories, Inc. products or lots are impacted by this recall.

Information has been sent to Pharmacists alerting them of the details pertaining to this recall. As described in these recall communications, pharmacists who may have dispensed Sodium Polystyrene Sulfonate Suspension, USP, 15 g/60 mL Unit dose bottles from Lots 856396A and 856693A are instructed to contact those patients to return the affected product to the pharmacist.

Pharmacists and wholesalers that have any Sodium Polystyrene Sulfonate Suspension, USP, 15 g/60 mL Unit dose bottles from Lot 856396A or Lot 856693A have been instructed to discontinue distribution and use of these lots immediately and contact Capital Returns at 888.839.7837 for any questions regarding the recall returns. Requests for additional information should be referred to Roxane Laboratories Technical Product Information at 800.962.8364.

Advice For Patients Taking Sodium Polystyrene Sulfonate Suspension USP, 15 g/60 Ml Unit Dose Bottles

If your pharmacist has notified you that you may have received a bottle from one of the lots listed in this recall, please return your Sodium Polystyrene Sulfonate Suspension, USP, 15 g/60 mL Unit dose bottles to your pharmacist.

If you have NOT been notified by your pharmacist, please check your product to determine if it is from either of the two affected lots: Sodium Polystyrene Sulfonate Suspension, USP, 15 g/60 mL Unit dose bottles from Lot 856396A Exp April 2010, or Lot 856693A Exp May 2010. If the product has either of these two lot numbers on the bottle, please contact your pharmacist for further instructions. This recall has been limited to these two specific lots.

Roxane Laboratories is working with the US FDA on this voluntary recall. The products discussed in this press release are available by prescription only, and no injuries have been reported in relation to this issue.

Bench Scale Adapters Recalled by American Weigh Scales Due to Fire Hazard

Friday, July 11, 2008

Lucky Green Trading, Inc. Recalls Thai Basil Because of Possible Health Risk

Lucky Green Trading Company, Inc, of Garden Grove, CA is recalling Thai Basil , because it has the potential to be contaminated with Salmonella , an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.

Thai Basil was distributed through retail stores and direct delivery to customers in Southern California, Arizona , and Nevada on June 30, 2008.

The product was shipped in 14 LB cardboard cartons with 12 individual packages weighting approx.1.2 LB each in clear, unmarked, plastic bags. The exterior cartons were labeled "16 DE SEPTIEMBRE S/N SANTA ROSA TAPACHULA NAYARIT, C.P. 63731" "Thai Basil" and also had an attached sticker with Airway Bill #027 1947 0861.

No illnesses have been reported to date.

The recall was as the result of a random testing by the FDA which revealed that the finished products contained the Salmonella . The company has suspended distribution and importation of the product as FDA and the company continues their investigation.

Consumers who purchased basil should contact the store where they purchased the product to determine if their basil is the Thai basil involved in the recall. Consumers with questions may contact the company at (714) 554-9293.

Thursday, July 10, 2008

Lip Gloss and Jewelry Sets Sold Exclusively at Wal-Mart Recalled by F.A.F. Inc. Due to Risk of Lead Exposure

Lawn Mowers Recalled by American Honda Motor Corp. Due to Laceration Hazard

Shoelace and Necklace Children's Charms Recalled by Action Products International Due to Risk of Lead Exposure

Parragon Books Recalls Children's Necklaces Due to Risk of Lead Exposure

Salmolux Inc. Recalls Wild Alaskan Smoked Salmon Nova Lox Lot # 01418 Because of Possible Health Risk

Salmolux Inc. of Federal Way, WA, is recalling lot # 01418 of its Wild Alaskan Smoked Salmon Nova Lox sold in 3 ounce packages due to the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.

The recalled lot # 01418 of Wild Alaskan Smoked Salmon Nova Lox was distributed in Arizona, California, and Nevada, in Von's retail outlets and to Delaware, Florida, Georgia, Maryland, North Carolina, Pennsylvania, South Carolina, West Virginia, and Virginia in Food Lion retail outlets.

The product comes in a 3 ounce, blue package marked with lot # 01418 on its rear white label bearing the name of the product, its ingredients, and an expiration date.

No illnesses have been reported to date in connection with this problem.

After routine testing by the Florida Department of Agriculture and Consumer Services, Listeria monocytogenes was found in 3 ounce packages of Wild Alaskan Smoked Salmon Nova Lox.

Consumers who have purchased the recalled 3 ounce packages bearing the lot # 01418 of the salmon are urged to return them to the place of purchase for a full refund. Consumers with questions may contact the company at (253) 874-2026 x214.

This recall is being conducted with the knowledge of the Food and Drug Administration.

Wednesday, July 9, 2008

FDA Requests Boxed Warnings on Fluoroquinolone Antimicrobial Drugs

RR Note: These drugs can and do cause tendinitis and tendon rupture. This was first brought to our attention when we witnessed first hand this type of side effect last year. Cheers to the FDA for making the warning necessary and not optional.

The U.S. Food and Drug Administration (FDA) has notified manufacturers of fluoroquinolone antimicrobial drugs that a Boxed Warning in the product labeling concerning the increased risk of tendinitis and tendon rupture is necessary. Through its new authority under the Food and Drug Administration Amendments Act of 2007 (FDAAA), the agency also determined that it is necessary for manufacturers of the drugs to provide a Medication Guide to patients about possible side effects.

The FDA has notified the manufacturers of these drugs that a Risk Evaluation and Mitigation Strategy (REMS) is necessary to ensure that the benefits of the drug outweigh the risks. The Medication Guide will be considered to be an element of the REMS. The new Boxed Warning and Medication Guide would strengthen warning information already included in product labeling for the fluoroquinolone class of systemic antimicrobial drugs.

Fluoroquinolones are drugs approved for the treatment or prevention of certain bacterial infections. Like other antibacterial drugs, fluoroquinolones do not treat viral infections such as colds or flu.

"Fluoroquinolones are effective in treating certain bacterial infections, but health care professionals and patients need to be aware of the increased risk associated with the use of these drugs of developing tendinitis and tendon rupture, particularly for certain patient populations," said Edward Cox, M.D., director, Office of Antimicrobial Products, Center for Drug Evaluation and Research. "The FDA believes it is important to highlight and strengthen information regarding possible side effects of fluoroquinolones because it may affect decisions about the relative risks and benefits associated with these products."

The FDA has conducted a new analysis of the available literature and post-marketing adverse event reports. This new analysisreconfirmsthat use of fluoroquinolones is associated with an increased risk of tendon rupture. It alsodemonstrates that despite the current warning of tendon rupture in the labeling for the fluoroquinolones, large numbers of tendon-related adverse events continue to be reported. The FDA considers this new analysis to be "new safety information" as defined in FDAAA.

The FDA also issued Information for Health Care Professionals today to alert health care professionals to the increased risk of tendinitis and tendon rupture in patients taking these drugs and to highlight new information concerning who may be at higher risk for this side effect.

The risk of developing fluoroquinolone-associated tendinitis and tendon rupture is further increased in people older than 60, in those taking corticosteroid drugs, and in kidney, heart, and lung transplant recipients. Patients experiencing pain, swelling, inflammation of a tendon or tendon rupture should be advised to stop taking their fluoroquinolone medication and to contact their health care professional promptly about changing their antimicrobial therapy. Patients should also avoid exercise and using the affected area at the first sign of tendon pain, swelling, or inflammation.

Manufacturers are being notified of the need to change labeling so that all of the drugs in the class carry uniform updated warning language. These warnings would apply to fluoroquinolones for systemic use (e.g., pills, tablets, capsules and injectable formulations). The warnings would not apply to fluoroquinolones for topical ophthalmic or otic use (e.g., eye and ear drops).

Fluoroquinolone manufacturers are required to submit the safety labeling changes, including the strengthened warnings and the Medication Guide, to the FDA within 30 days, or to provide a reason why they do not believe such labeling changes are necessary. If they do not submit new language, or the FDA disagrees with the new language the company proposes, FDAAA provides strict timelines for resolving the labeling changes and allows the agency to issue an order directing the labeling change as deemed appropriate to address the new safety information. In addition, in accordance with FDAAA, sponsors will be required to assess whether their REMS are achieving the goal of informing patients of the risk of tendon-rupture. These assessments may include a survey of patients' and prescribers' understanding of the risks of tendon-rupture and whether the Medication Guide is being distributed and dispensed with the drug.

Health care professionals should consider the potential benefits and risks for each patient. While most patients tolerate these medicines well, occasionally some will develop other serious adverse reactions that may include convulsions, hallucinations, depression, abnormalities in heart rhythm, or severe diarrhea.

The medications involved in this action are: Cipro and generic ciprofloxacin, Cipro XR and Proquin XR (ciprofloxacin extended release), Factive (gemifloxacin), Levaquin (levofloxacin), Avelox (moxifloxacin), Noroxin (norfloxacin), and Floxin and generic ofloxacin.

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Friday, July 4, 2008

Black Cat(r) Fireworks Recalls Fireworks Due to Injury Hazard

Children's Jewelry Recalled by Bead Bazaar USA Due to Risk of Lead Exposure

Bayside Furnishings Recalls Youth Bed Toy Chests Sold at Costco After the Death of a 22-Month-Old Child

Fireworks Over America Recalls Fireworks Due to Shock Hazard

Thursday, July 3, 2008

Hayes Bicycle Group Recalls Quick-Release Devices for Bicycles Due To Fall Hazard

Paintball Gun Adapters Recalled by RAP4 Due to Impact and Laceration Hazards

RadioShack Recalls Power Supplies Due to Electrocution and Fire Hazards

Wednesday, July 2, 2008

Sage Products Inc. Issues Voluntary Recall of 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation

As a precautionary measure, Sage Products announced a voluntary recall of limited lots of 2% Chlorhexidine Gluconate (CHG) Cloth Patient Preoperative Skin Preparation product. Testing of bulk 2% CHG solution from an outside supplier was found positive for Burkholderia cepacia (B. cepacia).

B. cepacia poses little medical risk to healthy people. However, people who have certain health problems such as weakened immune systems or chronic lung diseases, particularly cystic fibrosis (CF), may be more susceptible to infections with B. cepacia. B cepacia is a known cause of infections in hospitalized patients. The effects of B. cepacia on people vary widely, ranging from no symptoms at all, to serious respiratory infections, especially in patients with CF. The intended application of the 2% CHG Cloth product is topical, for the skin only, and it is not for oral or internal use.The recall includes the following products:

Product Code Number Lot Number

9705 10722
9707 10672
9705 10729
9707 10753
9706 10718
9707 10755
9707 10357
9707 10944
9707 10365
9707 10641

Product was distributed to U.S. hospitals and medical centers nationwide. Affected product was shipped between 4/28/08 and 6/19/08. This voluntary recall is being conducted with the knowledge of the Food and Drug Administration. Sage Products has received no reports of patient injury. No other products from Sage are included in this recall.

Customers who have these products should stop usage, sale and distribution, and should contact Sage Products to coordinate product return and replacement. Additional information is posted at www.sageproducts.com/recall.

Sage Products Customer Service hotline: 1-800-421-6556.
Return unused product to:Sage Products Inc.C/O Customer Service Department3909 Three Oaks Road, Cary, IL 60013