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

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: Wooden Toys

Units: About 375

Manufacturer: Earthentree of Kirkland, Wash.

Hazard: The recalled toys contain small parts or can break into small parts, posing a choking hazard. The recalled rattles violate the federal rattle standard. Some of the toys also have a string longer than 12 inches, which can pose a strangulation hazard to young children.

Incidents/Injuries: None reported.

Description: This recall involves a variety of wooden toys including egg shakers (maracas), pull toys, rattles, and trains. The toys are painted glossy red, orange, green, brown, yellow or natural wood.

Sold at: Earthentree's Web site, Fairs, Trade Shows and retail stores nationwide from December 2007 through May 2008 for about $7 to $34.

Manufactured in: India

Remedy: Consumers should immediately take the recalled toys away from children and contact Earthentree for exchange or refund.

Consumer Contact: For additional information, contact Earthentree at (800) 963-1593 between 9 a.m. and 5 p.m. PT Monday through Friday, or visit the firm's Web site at www.earthentree.com/recall

New England Ropes Recalls Climbing Lines Due to Fall Hazard

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: Maxim Apogee and Maxim Pinnacle Dynamic Climbing Lines/Ropes

Units: About 530

Manufacturer: New England Ropes, of Fall River, Mass.

Hazard: The climbing lines can break, posing a serious fall hazard for climbers.

Incidents/Injuries: None.

Description: Two types of climbing ropes have been included in this recall, the Maxim Apogee 9.1mm and Maxim Pinnacle 9.5mm. The Maxim Apogee 9.1mm is a 48 carrier climbing rope. The colors are yellow and black, and red and yellow. The model numbers are 3411-91 and 3415-91, with date codes 060801 thru 080601. The UPC codes are: 75396312299, 75396312298, 75396312301, and 75396312300. The Maxim Pinnacle 9.5mm is a blue 48 carrier climbing rope. The Model number is 3403-95, with date codes 070201 thru 080601. The UPC codes are 75396312292 and 75396312293. The date codes and the UPC codes are on the original packaging.

Sold at: Retailers nationwide from August 2006 through June 2008 for between $180 and $262.

Manufactured in: United States

Remedy: Consumers should immediately stop using the recalled dynamic climbing lines and contact the manufacturer for a free replacement.

Consumer Contact: For more information, consumers can contact New England Ropes toll-free at (866) 617-9038 anytime or visit the firm's Web site at www.neropes.com/Climbing.aspx

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

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: U-shaped Magnets, Bar Magnets, Magnet Sets and Magnet Needle Sets

Units: About 40,000

Importer: Pacific Science Supplies Inc., of Bensenville, Ill

Hazard: The paint on the magnets can contain excess levels of lead, violating the federal lead paint standard.

Incidents/Injuries: None reported.

Description: Magnets included in the recall:

"Large" and "Small" U-shaped Magnets: These magnets are in the shape of a "U" or horseshoe. One half of each magnet is painted red and is imprinted with the letter "N"; the other half is painted blue, and is imprinted with the letter "S".

"Large" and "Miniature" Bar Magnets: These magnets are in the shape of a bar. The magnets are painted half red and half white. The red half is imprinted with the letter "N" and the white half is imprinted with the letter "S".

Magnet Sets: This set contains a small u-shaped magnet, two small bar magnets, and two small compasses. All magnets are painted half red and half white. The red half is imprinted with the letter "N" and the white half is imprinted with the letter "S". The package is labeled "Magnets & Compasses."

Magnet Needle Sets: This set contains 10 sets of small cone-shape bases and elongated-diamond-shaped magnets which can be fastened into the bases. The magnets are painted half red and half white.

Sold through: Distributors nationwide which sell to educational institutions, including colleges, high schools and middle schools. A small number were sold through educational stores nationwide from April 2000 through February 2008 for about $9.

Manufactured in: China

Remedy: Consumers should immediately stop using these recalled magnets and contact the firm to receive a free replacement.

Consumer Contact: For additional information, contact Pacific Science Supplies Inc. at (800) 530-1500 between 9 a.m. and 4 p.m. CT Monday through Friday, or visit the firm's Web site at www.pacsciusa.com

Horseshoe Magnets Recalled by Dowling Magnets 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: Classic Horseshoe Magnet

Units: About 91,500

Manufacturer: Dowling Magnets, of Sonoma, Calif.

Hazard: The plastic coating on the magnets contains excessive levels of lead, which violates the federal lead paint standard.

Incidents/Injuries: None reported.

Description: This recall involves the Classic Horseshoe Magnets. The 6-inch tall horseshoe magnet has a red plastic coating on the "handle" end. Each "foot" of the magnet has an engraved "S" or and "N."

Sold at: Specialty retail stores and educational supply distributors nationwide from March 2003 through April 2008 for about $10.

Manufactured in: China

Remedy: Consumers should immediately take the classic horseshoe magnets away from children and contact Dowling Magnets to receive a free replacement horseshoe magnet.

Consumer Contact: For additional information, contact Dowling Magnets toll-free at (866) 623-3336 between 7 a.m. and 4 p.m. PST Monday through Friday, or visit the firm's Web site at www.dowlingmagnets.com. Consumers can also email the firm at support@dowlingmagnets.com

Kids II Recalls Infant Rattles Due to Choking Hazard

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: Bright Starts Ring Rattles

Units: About 19,000

Distributor: Kids II Inc., of Alpharetta, Ga.

Hazard: The tip of the rattle's antenna, which is attached to a bee figure, can detach and pose a choking hazard to small children.

Incidents/Injuries: Kids II has received two reports of the tip of the antenna detaching from the rattle, including one report that the purple ball from the tip of the antenna was in the baby's mouth. No injuries have been reported.

Description: The soft toy rattle is a bee with a yellow head, ring-shaped green body, blue/green wings and purple/red antennas. Model number 8534 and date code PA8 are printed on a sewn-in label on the bee's head.

Sold at: Toy stores, mass merchandisers, and other retail stores nationwide from January 2008 through June 2008 for about $2-3.

Manufactured in: China

Remedy: Consumers should immediately take the recalled rattles away from small children and contact Kids II to receive a free replacement rattle.

Consumer Contact: For additional information, contact Kids II toll-free at (877) 325-7056 between 8 a.m. and 5 p.m. ET Monday through Friday, or visit the firm's Web site at www.kidsii.com

Cost Plus Recalls Santorini Chairs Due to Fall Hazard

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: Santorini Chairs

Units: About 8,600

Manufacturer: Cost Plus Inc., of Oakland, Calif.

Hazard: The seat weld can fail and allow the chair to collapse, posing a fall hazard to consumers.

Incidents/Injuries: Cost Plus has received reports of four incidents involving weld failure. No injuries have been reported.

Description: This recall involves Santorini outdoor stacking chairs. The black metal chairs have vertical bars on the back and horizontal bars across the base.

Sold at: Cost Plus and World Market stores nationwide from January 2008 through April 2008 for about $50.

Manufactured in: Taiwan

Remedy: Consumers should immediately stop using the chairs with side weld joints (see below) and return them to any Cost Plus or World Market store for a full refund or exchange. Chairs with rear weld joints (see below) are not included in this recall. To identify if the chair is part of this recall consumers should locate the seat base weld on the underside of the chair. Weld joints located on the sides of the seat are included in this recall.

Consumer Contact: For additional information, contact Cost Plus toll-free at (877) 967-5362 between 7 a.m. and 12 a.m. ET daily, or visit the firm's Web site at www.worldmarket.com

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

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: "Sky Scrambler" and "The Sharper Image" Wireless Indoor Helicopters

Units: About 685,000

Importer/Distributor: Innovage LLC, of Foothill Ranch, Calif.

Hazard: The rechargeable lithium ion battery inside the helicopters can overheat, catch fire, and ignite nearby combustibles, posing fire and burn hazards to consumers.

Incidents/Injuries: Innovage has received two reports of incidents of the toy helicopters igniting, including one burn injury to a consumer's fingertip.

Description: The "Sky Scrambler" and "The Sharper Image" toy helicopters have yellow, red or blue decals. BH26047 is printed on the Sky Scrambler's tail. "The Sharper Image" is printed on the tail of "The Sharper Image" helicopters.

Sold at: Mass merchandisers, department stores, drug stores, and other retail stores nationwide, and on the Web from June 2007 through May 2008 for about $20.

Manufactured in: China

Remedy: Consumers should immediately stop using the recalled helicopters and contact Innovage for a full refund.

Consumer Contact: For additional information, contact Innovage toll free at (866) 672-2630 between 7 a.m. and 7 p.m. PT Monday through Friday, visit the firm's Web sites at www.innovage.net and www.copterrecall.org or email the firm at returns@copterrecall.org

Reebok International Ltd. Recalls Exercise Cycles Due to Laceration Hazard

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: Reebok Studio Exercise Cycles

Units: About 20,000

Manufacturer: Fitness Associates Incorporated (F.A.I.), under license from Reebok International Ltd., of Canton, Mass. Note: F.A.I. is no longer in business.

Hazard: The alloy cranks on the exercise cycles can break during use, posing a laceration and abrasion hazard to users.

Incidents/Injuries: Reebok International Ltd. has received five reports of cranks breaking and causing lacerations. Three consumers required stitches.

Description: The Reebok Studio Cycle is an upright exercise bike used primarily in fitness centers and other institutional settings. The recalled bicycle is black with silver cranks. The unit has an internal belt drive. The base of the bicycle is a single piece that is welded to the frame. The legs are two straight horizontal bars with rounded edges. There is a logo located on the side of the exercise cycle that shows a person riding a bicycle.

Sold by: F.A.I. to health clubs and specialty fitness dealers nationwide from 1997 through 2000. The bicycles were not sold directly to consumers.

Manufactured in: United States

Remedy: Consumers should stop using the recalled Studio Cycle immediately, and owners should contact Reebok International Ltd. to receive a discount on a model currently made by a licensee of Reebok.

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

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: Amsterdam Bicycles

Units: About 9,500

Importer: Electra Bicycle Company, LLC of Vista, Calif.

Hazard: The interior alignment tabs of the bicycle's chainguard can be pushed against the chain causing it to derail, which poses a risk of injury to riders.

Incidents/Injuries: Electra has received four reports of the chainguard derailing the chain, including one report of minor cuts and abrasion from a fall.

Description: This recall involves some Amsterdam model bicycles in the Classic 3, Original 3, Royal 8, and Sport 3 styles. The bicycles have an enclosed chainguard. "Electra" and "Amsterdam" are printed on the bicycle's frame and/or chainguard. Bicycles with frame numbers beginning with "F06" or "EL" or bicycles with chainguards marked "06/08" are not included in this recall. The frame number is located on the underside of the bottom bracket.

Sold by: Authorized Electra Bicycle dealers nationwide from January 2007 through June 2008 for between $400 and $850.

Manufactured in: Taiwan

Remedy: Consumers should immediately stop riding the recalled bicycle and bring it to an Electra Bicycle dealer for a free inspection and replacement chainguard part.

Consumer Contact: For additional information, contact Electra Bicycle at (800) 261-1644 between 9 a.m. and 5 p.m. PT Monday through Friday, or visit the firm's Web site at www.electrabike.com (pdf)

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

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: It's My Binky's Personalized Pacifiers

Units: About 115,000

Importer: It's My Binky, of Henderson, Nev.

Hazard: The pacifier button, ring handle and shield with nipple can detach, posing a choking hazard to infants.

Incidents/Injuries: It's My Binky has received two reports of the pacifier button, ring handle and shield with nipple detaching. No injuries have been reported.

Description: The recalled pacifiers have "Japlo" imprinted on the front of the pacifier shield at the bottom, center. The pacifiers were sold in blue, white and pink with various words or designs printed on the button of the pacifier. Examples of text and symbols printed on recalled Japlo pacifiers include but are not limited to the following:

BLUE (pacifier w/text)
Image of a skull (no text)
stud muffin
prince charming
my mom rocks
mute button
my dad rocks
momma's boy
insomniac
future ceo
little monster
flirt
bad to the bone

WHITE (pacifier w/text)
image of a skull (no text)
stud muffin
prince charming
princess
my mom rocks
mute button
little monster
future ceo
daddy's girl
born to shop

PINK (pacifier w/text)
spoiled
princess
my mom rocks
mute button
my dad rocks
insomniac
future ceo
flirt
daddy's girl
born to shop

Sold at: Nordstrom and baby boutique retail stores nationwide and online at www.itsmybinky.com from February 2006 through June 2008 for between $5 and $6.

Manufactured in: Malaysia

Remedy: Consumers should immediately take these pacifiers away from children and return them to the store where purchased or contact the firm if purchased online to receive a free replacement pacifier.

Consumer Contact: For additional information, contact It's My Binky toll-free at (888) 689-9444 between 8 a.m. and 4:30 p.m. Monday through Friday PT or visit the firm's website at www.itsmybinky.com or e-mail Danielle Riiber at Danielle@itsmybinky.com

Indoor Lighting Fixtures Recalled by Lithonia Lighting Due to Fire Hazard

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: Indoor Lighting Fixtures

Units: About 1,200

Manufacturer/Distributor: Lithonia Lighting, of Conyers, Ga.

Hazard: A thermal protector could be missing from the lighting fixtures, posing a risk of overheating and fire.

Incidents/Injuries: None reported.

Description: The recalled fixture is a ceiling-mounted downlight. Model number LV3R is included in this recall and is printed on a UL label inside the light's housing.

Sold at: Electrical distributors and electrical sales representatives nationwide from April 2007 through May 2008 for between $60 and $80.

Manufactured in: United States

Remedy: Consumers should immediately stop using the lighting fixtures and contact Lithonia Lighting to arrange for a free replacement fixture.

Consumer Contact: For additional information, contact Lithonia Lighting at (800) 315-4935 between 8 a.m. and 5 p.m. ET Monday through Friday, or visit the firm's Web site at www.lithonia.com

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

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: Engines used in SpeeCo and Huskee Brand Log Splitters

Units: About 6,400

Manufacturer: American Honda Motor Corp., of Torrance, Calif.

Hazard: The engine's fuel tank can crack and leak, posing a risk of fire or explosion.

Incidents/Injuries: None reported.

Description: The recall involves Honda engines (model type GCV160LA N1A) used in Split Master by SpeeCo and Huskee brand log splitters. Only engine serial numbers between 5547012 and 6880908 are included in the recall. The serial number is located below the upper shroud near the oil dip-stick. The following models of log splitters are affected by the recall and are either silver/black or red/black colored.

Huskee Log Splitter
LS401227TS (22 Ton)
LS401228NO (27 Ton)

SpeeCo Split Masters
LS401228SP (22 Ton)
LS401227NO (22 Ton)
LS401225NO (25 Ton)

Sold at: The log splitters with the recalled engines were sold at outdoor power equipment dealers and Tractor Supply stores nationwide from January 2007 through June 2008 for between $1,150 and $1,500.

Manufactured in: United States

Remedy: Consumers should immediately stop using the affected log splitters and contact any Honda Lawn and Garden dealer or Honda Engine dealer for a free repair. Registered owners of the recalled log splitters will be mailed a notice.

Consumer Contact: For additional information, contact Honda at (800) 426-7701 between 8:30 a.m. and 5 p.m. ET Monday through Friday, or visit the firm's Web site at www.hondapowerequipment.com

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

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: TV Stands

Units: About 6,700

Distributor: Studio RTA, of Pico Rivera, Calif.

Manufacturer: King Pao Enterprise Co. Ltd., of Guangdong, China

Hazard: The stability of the stand does not meet industry standards to prevent TV tip-over, posing a risk of injury or death to consumers.

Incidents/Injuries: None reported.

Description: This recall involves "Silhouette" TV stands with black or brushed silver and black frames and three glass shelves. Models included in the recall are 403650 (brushed silver and black) and 404191 (black). Model numbers are printed on the packaging and instruction sheet.

Sold by: Shopko and Boscov's stores nationwide from September 2007 through June 2008 for about $140.

Manufactured in: China

Remedy: Consumers should immediately remove the TV from stand and contact Studio RTA to receive a free repair kit.

Consumer Contact: For additional information, contact Studio RTA at (888) 309-0299 between 7 a.m. and 5 p.m. PT Monday through Friday. Consumers can also visit the firm's Web site at www.studiorta.com

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

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: Bench Scale Adapters

Units: About 1,300

Manufacturer: American Weigh Scales, of Charleston, S.C.

Hazard: The recalled bench scale adapters can smoke, catch fire and melt, posing a fire hazard to consumers.

Incidents/Injuries: American Weigh Scales has three reports of incidents involving the adapters smoking after plugged in. No injuries have been reported.

Description: The recalled bench adapters are silver colored. "MINI CHARGER" is printed on the back of the adapter. When plugged in a red light shines through a blue plastic piece on the outer side of the adapter. "AC Adapter" is printed on a white label on the inner side. The adapters are used with bench scale model AMW-13, AMW-1000, AMW-2000, and AMW-500i.

Sold at: Online at www.americanweigh.com, www.gramscales.com, www.kitchenscales.com, and www.postalscales.com and through American Weigh Scales distributors from February 2008 through March 2008 for about $10.

Manufactured in: China

Remedy: Consumers should immediately stop using the adapters and return them to American Weigh Scales for a credit towards the purchase of another product, or to receive a replacement adapter. Replacement adapters will be black in color. American Weigh Scales will reimburse consumers for shipping and handling charges on returns.

Consumer Contact: For additional information, contact American Weigh Scales toll-free at (866) 643-3444 between 9 a.m. and 6 p.m. ET Monday through Friday, or visit the firm's Web site at www.americanweigh.com

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

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: "Faded Glory" Lip Gloss, Locket, and Bracelet Sets

Units: 30,000

Importer: F.A.F. Inc., of Greenville, R.I.

Distributer: Wal-Mart Stores Inc., of Bentonville, Ark.

Hazard: The lobster claw clasp on the bracelet contains high levels of lead, which is toxic if ingested and can cause adverse health effects.

Incidents/Injuries: None reported.

Description: The recalled three-piece sets contain a rectangle-shaped lip gloss container, a heart-shaped locket necklace, and a charm bracelet. The following models are included in the recall:

Item | Model Number | UPC
Frog Set | 6709-4250 | 72783357703
Monkey Set | 6709-4251 | 72783357704
Cat Set | 6709-4252 | 72783357705

"Faded Glory", the model number, and UPC are printed on the product's hangtag.

Sold at: Wal-Mart stores nationwide from May 2008 through June 2008 for about $6.

Manufactured in: China

Remedy: Consumers should immediately take the bracelet away from children and return the set to any Wal-Mart store for a full refund.

Consumer Contact: For additional information, contact F.A.F. Inc. at (800) 949-3311 between 8:30 a.m. and 4:30 p.m. ET Monday through Friday, or visit the firm's Web site at www.faf.com

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

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: Honda Lawn Mowers

Units: 20,500

Manufacturer: American Honda Motor Corp., of Torrance, Calif.

Hazard: The lawn mower's rear shield can break off allowing debris to be thrown toward the operator, which poses a laceration hazard to consumers.

Incidents/Injuries: American Honda has received one report of a shield breaking off the lawn mower. No injuries have been reported.

Description: This recall involves HRX walk-behind lawn mowers with model numbers HRX217(K)2HXA and HRX217(K)2HMA. The model and serial number are printed on a label located on the upper rear of the mower deck. Serial numbers included in the recall are MAGA-1500001 through 1520532. The recalled lawn mowers are red with "HONDA" written on the bag.

Sold by: Authorized American Honda Motor Corp. dealers and Home Depot stores nationwide from October 2007 to June 2008 for about $900.

Manufactured in: United States

Remedy: Consumers should immediately stop using the recalled lawn mowers and contact their local Honda Lawn and Garden dealer to schedule a free repair. Registered owners of the recalled lawn mowers have been contacted by direct mail notification.

Consumer Contact: For additional information, contact Honda at (800) 426-7701 between 8:30 a.m. and 5 p.m. ET Monday through Friday, or visit Honda's Web site at www.hondapowerequipment.com

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

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: Children's Charm Craft Kits

Units: 18,500 units

Importer: Action Products International Inc., of Ocala, Fla.

Hazard: The clasp in the charm craft kits contains high levels of lead. Lead is toxic if ingested by young children and can cause adverse health effects.

Incidents/Injuries: None reported.

Description: This recall involves "Super Dooper Charms" (item #63403) and "Shoelace Charms" (item #67310) children's charm craft kits. The craft kits contain components (i.e., charms, beads, wire, clasps) to assemble necklaces, jewelry accessories, or charms that can be hooked on shoelaces, backpacks, or used as zipper pulls. The item number can be found on the back of the package.

Sold through: Various retailers nationwide from July 2007 through April 2008 for about $17 for the "Super Dooper Charms" kit and $6 for the "Shoelace Charms" kit.

Manufactured in: China

Remedy: Consumers should immediately take the recalled product away from children and contact Action Products International for instructions on returning it for a free replacement.

Consumer Contact: For additional information, contact Action Products International at (800) 772-2846 between 8:30 a.m. and 5 p.m. ET Monday through Friday or visit the company's Web site at www.apii.com

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

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: Children's Necklaces with Ballet Shoes Charms

Units: About 500,000

Distributor: Parragon Inc., New York, New York

Importer: Parragon Books Ltd., of United Kingdom

Hazard: Solder on the charm of the necklace may contain high levels of lead, which if ingested by young children can cause adverse health effects.

Incidents/Injuries: None.

Description: The recalled necklace has a silver-colored chain with a silver-colored charm consisting of a pair of ballet shoes and a bow. The necklace was provided with the purchase of a children's book entitled, The Magical Ballet Slippers (alternatively titled Ballerina's Magical Shoes), ISBN 1405411449, published by Parragon Books, Ltd. UPC 9781405411448 is printed on the back of the book. Spanish version, Las zapatillas magicas de la bailarina ISBN 1405448385; UPC 9781405448383. French version, Les petits chaussons magiques ISBN 1405449527; UPC 9781405449526.

Sold at: Retail chains and independent bookstores nationwide from January 2003 through June 2008 for about $7.

Manufactured in: China

Remedy: Consumers should immediately take the recalled necklaces away from children and contact Parragon for instructions on how to return the necklace and receive a free children's book.

Consumer Contact: For more information, consumers can contact Parragon 24 hours a day, 7 days a week, toll-free at (888) 480-2854, or visit the firm's Web site: www.parragonrecall.com

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

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: Screech and Scream Fountain Fireworks

Units: About 20,000

Distributor: Black Cat Fireworks, of Prairie Village, Kan. Importer: Shiu Fung Fireworks, of China

Hazard: The firework can produce a loud bang and unexpectedly scatter debris, posing an injury hazard to the user and bystanders.

Incidents/Injuries: No injuries have been reported. Description: The recalled Screech and Scream Fountain is a firework item with a yellow and red cylinder with red balls. The model name is printed on the front of the tube.

Sold at: Various fireworks stores nationwide from October 2006 through June 2008 for about $7.

Manufactured in: China

Remedy: Consumers should immediately stop using the product and return it to either the place of purchase or Black Cat Fireworks for a full refund.

Consumer Contact: For additional information, call Black Cat Fireworks collect at (913) 649-0537 between 9 a.m. and 5 p.m. CT Monday through Friday, or visit the firm's Web site at www.blackcatfireworks.com

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

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: "It's a Girl Thing" Bracelets, Necklaces, and Phone Charms

Units: About 13,000

Distributor: Bead Bazaar USA Inc., of Rockville, Md.

Hazard: The children's jewelry could contain high levels of lead. Lead is toxic if ingested by young children and can cause adverse health effects.

Incidents/Injuries: None reported. Description: This recall involves "It's a Girl Thing" metal necklaces, bracelets, and phone charms. The jewelry features a variety of charms including flowers, shoes, letters and butterflies. "It's a Girl Thing" is printed on the packaging along with the UPC numbers 633870018419 (bracelet), 633870018426 (necklace), and 633870018433 (phone charm).

Sold at: Retailers nationwide from February 2006 through June 2008 for about $6.

Manufactured in: China

Remedy: Consumers should immediately take the recalled jewelry away from children and return it to the place of purchase for a full refund.

Consumer Contact: For additional information, contact Bead Bazaar USA at (800) 838-1769 between 9 a.m. and 5 p.m. ET Monday through Friday or visit the company's Web site at www.beadkit.com

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

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: LaJolla Boat Bed and Pirates of the Caribbean Twin Trundle Beds

Units: About 9,350

Importer: Bayside Furnishings (a division of Whalen(tm)), of San Diego, Calif.

Hazard: The lid supports on the toy chests fail to prevent the lid from closing too quickly, posing an entrapment and strangulation hazard to young children.

Incidents/Injuries: CPSC received one report of a death involving a 22-month-old boy of Roseville, California. He strangled when the lid of the toy chest fell on the back of his head and entrapped his neck on the edge of the chest of a LaJolla Boat Bed.

Description: This recall involves two styles of Bayside youth beds: the LaJolla Boat Bed and the Pirates of the Caribbean Twin Trundle Bed. The preassembled toy chests are designed in the shape of a ship or boat's "bow" and attached to the beds as a footboard. The LaJolla Boat Bed toy chest has a hardwood top and white wood base with a blue stripe. The Pirates Boat Bed toy chest has a hardwood top, wheel shape and brown wood base with decorative carvings.

Sold at: Costco and furniture retail stores nationwide and Costco.com from January 2006 through May 2008 for between $700 and $1,400.

Manufactured in: China Remedy: Consumers should immediately stop children from using the recalled toy chests and contact the firm for instructions on receiving a free repair kit with replacement lid supports.

Consumer Contact: For additional information, contact Bayside at (877) 494-2536 anytime, or visit the firm's Web site at www.baysidefurnishings.com to register online for the free repair kit.

Fireworks Over America Recalls Fireworks Due to Shock Hazard

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: Oh Chute Parachute with Streamer Fireworks

Units: About 84,250 Distributor: Fireworks Over America, of Springfield, Mo.

Hazard: The parachutes can become entangled in overhead power lines causing a shock hazard to users and bystanders.

Incidents/Injuries: Fireworks Over America has received one report of entanglement, in which a consumer's hand was burned and shocked.

Description: The recalled Oh Chute Parachute with streamers is a firework item with a light blue cylinder with white clouds. The model name is printed in triplicate on the front of the tube and FOA #2085 is on the lower back of the tube. This item is sold separately or in a box of four.

Sold by: Various fireworks stores nationwide from April 2007 through June 2008 for about $2.50 each and $8 a box.

Manufactured in: China

Remedy: Consumers should immediately stop using the product and return it to either the place of purchase or Fireworks Over America for a full refund.

Consumer Contact: For additional information, contact Fireworks Over America at (800) 345-3957 between 9 a.m. and 5 p.m, CT Monday through Friday, or visit the firm's Web site at www.fireworksoveramerica.com

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Thursday, July 3, 2008

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

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: SunRinglé Hollow Quick Release Devices for Bicycles

Units: About 800

Manufacturer: Hayes Bicycle Group, of Mequon, Wis.

Hazard: The quick release devices can unexpectedly fail or break when locked in position on the bicycle, causing the rider to lose control, which poses a serious fall hazard.

Incidents/Injuries: Hayes Bicycle Group has received four reports of the quick release device breaking. No injuries have been reported.

Description and Models: This recall involves the SunRinglé Hollow Quick Release Devices for bicycles and includes models Hollow CroMo Front 100mm, Hollow CroMo Rear 130mm, and Hollow CroMo Rear 135mm. These devices have hollow skewers. They were sold individually or with SunRinglé front and rear wheels with model names Black Flag, Disc o Flea, Charger, STR8 Track, Accelerator R3.00C and Accelerator T3.0C. "Ringlé" is stamped on the lever. Quick release devices with a solid skewer are not included in this recall.

Sold at: Bicycle specialty stores and dealers nationwide from June 2007 through May 2008 for about $17.

Manufactured in: Taiwan

Remedy: Consumers should stop riding bicycles with the recalled quick release devices immediately, remove the quick release device and bring it to their local bike dealer or retailer for a free inspection and replacement.

Consumer Contact: For more information, contact Hayes Bicycle Group at (888) 686-3472 between 8 a.m. and 5 p.m. CT Monday through Friday, or visit the firm's Web site at www.hayesbicycle.com

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

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: Paintball Gun Remote Line Adapters

Units: About 2,000

Manufacturer: RAP4 (Real Action Paintball Inc.), of San Jose, Calif.

Hazard: The remote line adapter can burst when over tightened, posing serious impact and laceration hazards to consumers. Incidents/Injuries: RAP4 has received two reports of incidents involving the recalled remote line adapters, including one that scratched a consumer when it burst.

Description: The remote line adapter is used to connect a paintball gun to a pressurized CO2 tank. The adapter is a black cylinder and is attached to a black remote line cord. "RAP4" and the "SN" (serial number) are printed on the adapters.

Sold at: Online at www.RAP4.com from October 2006 through April 2008 for about $40.

Manufactured in: China

Remedy: Consumers should immediately stop using the paintball gun adapter and contact the firm for a free replacement adapter.

Consumer Contact: For additional information, contact RAP4 at (800) 404-9029 from 8 a.m. to 5 p.m. PT Monday through Friday, 10 a.m. to 5 p.m. PT Saturdays, or visit the firm's Web site at www.rap4.com

RadioShack Recalls Power Supplies Due to Electrocution and Fire Hazards

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: 13.8V DC Power Supplies

Units: About 160,000 Importer: RadioShack Corp., of Fort Worth, Texas

Hazard: The recalled power supplies are wired incorrectly, posing electrocution and fire hazards.

Incidents/Injuries: None reported.

Description: The recall involves RadioShack 13.8V DC Power Supplies, catalog numbers 22-507 and 22-508 with date codes from 08A04 through 01A08. Date code format is MMAYY where MM is the month and YY is the year. The catalog number and date code are located on the back of the power supply. Power Supplies with a green dot on the product and the product's packaging have already been repaired and are not included in the recall.

Sold at: RadioShack stores nationwide from October 2004 through January 2008 for between $50 and $85.

Manufactured in: China

Remedy: Consumers should unplug the recalled power supply immediately and take it to any RadioShack store for a free repair. Registered owners of the recalled power supplies will be mailed a notice.

Consumer Contact: For additional information, contact RadioShack at (800) 843-7422 anytime, or visit the firm's website at www.radioshack.com/recall

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

Redcat Racing Recalls Remote Controlled Toy Vehicles Due to Remote Control Defect

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: Redcat Racing FM Remote Controlled Vehicles

Units: About 1,400 Distributor: Redcat Racing Co., of Phoenix, Ariz.

Hazard: The remote control unit can lose its signal, causing the toy vehicle to lose control, posing a risk of injury to the user or bystanders.

Incidents/Injuries: Redcat Racing has received about 15 reports of remote control malfunctions. There have been no injuries reported.

Description: The recalled remote controls were included in the remote cars as shown below. These cars were sold in a variety of colors. The model name and numbers are located on the body of the vehicle or on the retail packaging:

Model Description Model NumberHurricane XP (1/8 Road Buggy) Green/Flame HURRICANEXP-GF Orange/Black HURRICANEXP-OB Orange/Flame HURRICANEXP-OF Yellow/Flame HURRICANEXP-YFHurricane XP Pro(1/8 Road Buggy) Green/Flame-Blue Aluminum HURRICANPRO-GF Silver-Blue Aluminum URRICANPRO-SB Yellow/Flame-Blue Aluminum HURRICANPRO-YFAvalanche XP (1/8 Off Road Truck) Blue/Yellow AVALANCHEXP-94087-BY Red/Green AVALANCHEXP-94087-RG Red AVALANCHEXP-94087-RMonsoon XP (1/8 Off Road Truggy) Blue/Yellow MONSOONXP-94085-BY Red/White/Blue MONSOONXP-94085-RWB Red/Yellow MONSOONXP-94085-RYTsunami Ultrawide (1/10 Truggy) Blue/Flame TSUNAMIUW-BF-94110W Red/Flame TSUNAMIUW-RF-94110W

Sold by: Authorized dealers nationwide from March 2007 through April 2008 for between $260 and $400.

Manufactured in: China

Remedy: Consumers should immediately stop using the product and contact Redcat Racing for a replacement remote control.

Consumer Contact: For additional information, contact Redcat Racing Co. collect at (602) 454-6445 between 8 a.m. and 5 p.m. MT Monday through Friday or at www.redcatracing.com

Infant Garments Recalled by Rashti & Rashti Due to Choking Hazard

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: Taggies(tm) Sleep'n Play Infant Garments

Units: About 6,200

Importer: Rashti & Rashti, of New York, N.Y.

Hazard: The snaps on these garments can detach, posing a choking hazard to young children.

Incidents/Injuries: None reported.

Description: The recall involves two Taggies(tm) Sleep 'n Play style infant garments sold in purple or blue and white with style number listed in chart. The infant garments are one piece footed coveralls with snaps down the front. These garments were sold in sizes 0-3 months, 3-6 months, and 6-9 months. RN #27829 is printed on the care label sewn into the garment. Style numbers are printed on the hangtag of the garments.
Style# UPC Color DescriptionT21301H 0-22253-21301-3 Purple Butterfly Applique Sleep'n Play (0-3M)T21302H 0-22253-21302-0 Purple Butterfly Applique Sleep'n Play (0-6M)T21301H 0-22253-21303-7 Purple Butterfly Applique Sleep'n Play (6-9M)T20816H 0-22253-20816-3 Blue and White Fun Dog Print Sleep'n Play (0-3M))T20817H 0-22253-20817-0 Blue and White Fun Dog Print Sleep'n Play (3-6M)T20818H 0-22253-20818-7 lue and White Fun Dog Print Sleep'n Play (6-9M)

Sold at: Buy Buy Baby, Dillards, Nordstrom, and other specialty stores and Internet retailers nationwide from June 2007 through May 2008 for about $20.

Manufactured in: China

Remedy: Consumers should immediately take these garments away from children and contact Rashti & Rashti to receive a refund.

Consumer Contact: For additional information, contact Rashti & Rashti at (888) 594-3730 between 8:30 a.m. and 9:30 p.m. ET Monday through Friday, or visit the firm's Web site at www.rashtiandrashti.com