Recall Roundup: May 2008

Friday, May 30, 2008

FDA Advises Patients to Switch to HFA-Propelled Albuterol Inhalers Now

The U.S. Food and Drug Administration today issued a public health advisory to alert patients, caregivers and health care professionals to switch to hydrofluoroalkane (HFA)-propelled albuterol inhalers because chlorofluorocarbon (CFC)-propelled inhalers will not be available in the United States after Dec. 31, 2008.

CFC-propelled albuterol inhalers are being phased out because they are harmful to the environment by contributing to depletion of the ozone layer above the Earth's surface.

Three HFA-propelled albuterol inhalers have been approved by the FDA: Proair HFA Inhalation Aerosol, Proventil HFA Inhalation Aerosol, and Ventolin HFA Inhalation Aerosol. In addition, an HFA-propelled inhaler containing levalbuterol, a medicine similar to albuterol, is available as Xopenex HFA Inhalation Aerosol.

"Concern about the environment stimulated the need to phase out CFCs," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research. "The FDA wants to emphasize that HFA-propelled albuterol inhalers are safe and effective replacements for CFC-propelled albuterol inhalers."

Albuterol inhalers are used to treat bronchospasm (wheezing) in patients with asthma and chronic obstructive pulmonary disease (COPD), which includes chronic bronchitis and emphysema. Patients use albuterol inhalers to deliver medicine directly into the lungs.

The FDA is urging patients to talk with their health care professionals now about switching to HFA-propelled albuterol inhalers. These products are safe and effective replacements for CFC-propelled albuterol inhalers.

Manufacturers have been increasing production of HFA albuterol inhalers, so an adequate supply is available now.

HFA-propelled albuterol inhalers may taste and feel different than the CFC-propelled albuterol inhalers. The spray of an HFA-propelled albuterol inhaler may feel softer than that of a CFC-propelled albuterol inhaler. Patients must also prime and clean HFA-propelled albuterol inhalers. Doing so prevents buildup of the drug in the inhalation device, and buildup can block the medicine from reaching the lungs. Each HFA-propelled albuterol inhaler has different priming, cleaning, and drying instructions, and patients should read and understand the instructions first before using the inhaler.

The phaseout of CFC-propelled inhalers is the result of the Clean Air Act and an international environmental treaty, the Montreal Protocol on Substances that Deplete the Ozone Layer. Under this treaty, the United States has agreed to phase out production and importation of ozone depleting substances including CFCs. No CFC-propelled albuterol inhalers may be produced, marketed or sold in the United States after Dec. 31, 2008.

Electric Candle Warmers Recalled by Provo Craft & Novelty Due to Fire Hazard

Jo-Ann Fabric & Craft Stores Recall Outdoor Benches Due to Fall Hazard

Remote-Controlled Helicopter Toys Sold Exclusively in Walgreens Recalled Due to Fire and Burn Hazards by TWIE

QuinCrafts Children's Jewelry Recalled Due to Risk of Lead Exposure

International Pharmaceuticals, Ltd. Issues a Voluntary Recall of all Viril-Ity-Power (VIP) Tabs, a Product Marketed as a Dietary Supplement

International Pharmaceuticals, Ltd., P.O. Box 5165, Bradford, MA 01835, announced today (May 29, 2008) that it is conducting a voluntary recall of all the company’s supplement product sold under the brand name of Viril-Ity-Power (VIP) Tabs, 560mg/serving.

International Pharmaceuticals, Ltd. 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, hydroxyhomosildenafil. 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.

VIP Tabs are sold in retail outlets nationwide and are packaged into 2-capsule blister packs and 8-capsule bottles.

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.

The Company advises that any unused portions be returned to CB Distributors in Benoit, Wisconsin, in accordance with return instructions/questions obtained by calling (800)-273-4137, Ext. 3.

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 at www.fda.gov/medwatch/report.htm.

The Company is working closely with the FDA in the recall process and is taking this voluntary action because it is committed to the quality and integrity of it’s products, and is always concerned with the health of persons who may have consumed this product.

The Company sincerely regrets any inconvenience to consumers, and is reviewing the procedures and policies of all firms involved with the manufacture of this product to ensure that there will be no subsequent issues with regard to the composition of this product in the future.

Thursday, May 29, 2008

Orval Kent Foods Recalls Single Limited Production Run of Amish Macaroni Salad Sold Under the Orval Kent and Yoder’s Brand Names

Orval Kent Foods is voluntarily recalling approximately 23,000 pounds of Amish Macaroni Salad that may pose a health risk.

This voluntary action is being taken in response to the results of a test conducted on a single package of Amish Macaroni Salad by the Ohio Department of Agriculture and Consumer Services, Division of Food Safety, for E. coli O157:H7.

It is important to note that no illnesses associated with consumption of this product have been reported.

The only product included in this recall is Amish Macaroni Salad with the following UPC codes and associated Use By dates:

* UPC 7945368281 Orval Kent Amish Macaroni Salad, 5 pound container, Use By 6/12/08
* UPC 7347468281 Yoder’s Amish Macaroni Salad, 1 pound container, Use By 6/7/08
* UPC 7347401045 Yoder’s Amish Macaroni Salad, 2 pound container, Use by 6/7/08
* UPC 7347488729 Yoder’s Amish Macaroni Salad, 5 pound container, Use By 6/7/08

This specific product was shipped to customers who have distribution to retail and food service establishments in the following areas: Delaware, Illinois, Indiana, Maryland, Michigan, New Jersey, New York, Ohio, and Pennsylvania.

E. coli O157:H7 causes a diarrheal illness often with bloody stools. Although most healthy adults can recover completely with a week, some people can develop a form of kidney failure that can lead to serious kidney damage and even death. Young children, the elderly and those with weak immune systems are most susceptible to foodborne illnesses.

No other Yoder’s or Orval Kent deli salads, or other code dates or UPC’s of the Amish Macaroni Salad are included in this recall.

Our highest priority is protecting the health and safety of our customers, consumers and their families. Today’s precautionary action is a measure to ensure this priority is carried out, and that we maintain the loyalty and trust of our consumers.

Consumers are urged to return all un-opened containers to their place of purchase for a full refund.

Consumers with any questions may contact Orval Kent at 1-800-544-1246.

Wednesday, May 28, 2008

Kids Station Toys Recalls Little Tikes Toy Cell Phones Due to Choking Hazard

Children's Hooded Sweatshirts Recalled by Adio Footwear Due to Strangulation Hazard

Tuesday, May 27, 2008

Counterfeit Circuit Breakers Recalled By Specialty Lamp International 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: Counterfeit Circuit Breakers labeled as "Square D"

Units: About 371,000

Distributor: Specialty Lamp International Inc., of Deerfield Beach, Fla.

Hazard: The recalled circuit breakers labeled "Square D" have been determined by Square D to be counterfeit and can fail to trip when they are overloaded, posing a fire hazard to consumers.

Incidents/Injuries: None reported.

Description: The counterfeit circuit breakers are black and are labeled as Square D QO-series models 115, 120, 130, 215, 220, 230, 240, 250, 260 and 2020 and Square D QOB-series models 115, 120, 130, 220, 230, 250, 260 and 1515. Actual Square D circuit breakers have (a) the amp rating written on the handle in white paint on the front of the breaker (authentic Square D circuit breakers manufactured prior to 2003 did not have white paint on the amperage numbers); (b) the Square D insignia molded onto the breaker side, and; (c) a yellow chromate mounting clip with half of the top of the clip visible. If your breaker, labeled as Square D, does not match this description, it could be counterfeit.

Sold by: Electrical product distributors nationwide from May 2005 through June 2006 for between $3 and $23.

Manufactured in: China or Unknown

Remedy: Consumers should contact Specialty to determine if the breaker they have is counterfeit and to arrange for a free inspection and replacement or refund if necessary.

Consumer Contact: For additional information, contact Specialty at (866) 650-3076 between 8 a.m. and 5 p.m. ET, by email bart@specialty-lamp.com, or visit the company's Web site at www.ebulb.net. This is not a Square D Company recall.

FDA Requests Recall of Xiadafil VIP Tabs

The U.S. Food and Drug Administration today requested that SEI Pharmaceuticals, of Miami, Fla., recall all Xiadafil VIP Tabs sold in 8 tablet bottles (Lot # 6K029) or blister cards of 2 tablets (Lot # 6K029-SEI) because these products contain a potentially harmful, undeclared ingredient that may dangerously affect a person's blood pressure and can cause other life-threatening side effects. These lots of Xiadafil VIP Tabs bear an expiration date of September 2009 (09/09). Xiadafil VIP Tabs are marketed as a dietary supplement for sexual enhancement and able to treat erectile dysfunction (ED).

Today's formal request follows an action by the state of Florida to prevent the further distribution of this product into consumer channels. FDA is advising consumers not to buy or use this product. The agency may take further regulatory action to protect consumers from this illegal product.

Although labeled as a dietary supplement and touted as "all-natural," Xiadafil VIP Tabs are an illegally marketed drug that contains a potentially harmful undeclared ingredient. FDA chemical analysis revealed that Xiadafil VIP Tabs contains hydroxyhomosildenafil, which is an analog of sildenafil, the active ingredient in Viagra, an FDA-approved prescription drug for ED.

This undeclared ingredient may interact with nitrates found in some prescription drugs (such as nitroglycerin) and can lower blood pressure to life-threatening levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. ED is a common problem in men with these medical conditions.

"Because these products are labeled as ‘all natural dietary supplements,' consumers may assume that they are harmless and pose no health risk," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research. "But an unsuspecting consumer with underlying medical issues may take these products without knowing that they can cause serious side effects and interact in dangerous ways with drugs that a consumer is already taking."

The FDA has not approved Xiadafil VIP Tabs for ED or any other drug use, and the safety and effectiveness of this product is unknown. The product is promoted and sold over the Internet, was given away as free samples at trade shows, and is sold in health food stores nationwide. The product may be packaged in bottles of eight tablets or blister cards of two tablets.

On May 13, 2008 Florida officials issued a "stop sale" action at SEI's distribution facility in Miami, Fla. This action required the firm to hold, intact, violative Xiadafil VIP Tabs found on-hand at the facility. The state of Florida's action to control the supply of the product, coupled with today's formal request by FDA to recall this product from the marketplace, will further reduce the likelihood that this potentially dangerous product is used by unsuspecting consumers.

Alternative products like Xiadafil VIP Tabs are often sought out because they are marketed as "all natural" or as not containing the active ingredients in approved, prescribed ED drugs. 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.

The FDA advises consumers who have used this product to discontinue use immediately and consult their health care professional if they have experienced any 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.

Additionally, the FDA recommends that consumers talk to their health care professional about FDA-approved treatments for ED.

Friday, May 23, 2008

Additional Incidents Prompt Re-Announcement of Recall of Gel Candles Due to Fire Hazard

Note: This recall is an expansion of an earlier recall announced in February 2007.

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: Gel Candles

Units: About 1,700

Manufacturer: M & A Global Technologies Inc., doing business as Spa at Home, of Tallahassee, Fla.

Hazard: The candles can have excessive flame height, posing a fire and burn hazard to consumers.

Incidents/Injuries: M & A Global Technologies has received four additional reports of higher than normal flames and flames coming in contact with nearby combustibles resulting in minor fires, smoke and soot damage. The company has also received one additional report of burn injuries to a consumer's hand.

Description: This recall involves Everlasting Jelly candles. Models include Champagne Glass with Heart, Model #502; Large Oval Bowl with Sand & Shells, Model #109-XL; Tumbler with Sand & Shells, Model #101-S; Round Shape with Curly Top and Red Roses, Model #506; Round Shape with Penguins, Model #604; Tumbler with Blue Roses & Leaves, Model #805-11; and Round Shape with Two Butterflies, Model #806-8. The candles were sold in clear glass containers of various sizes with a smaller glass of gel in the middle of the candle.

Sold at: Spa at Home stores and Spaathome.com nationwide from October 2003 through December2003 and October 2005 through December 2005 for between $9 and $50.

Manufactured in: United States

Remedy: Consumers should immediately stop using the candles and contact M & A Global Technologies for instructions on returning the product.

Consumer Contact: For additional information, contact M & A Global Technologies at (866) 224-8811 between 9 a.m. and 5 p.m. ET Monday through Friday, or visit the firm's Web site at www.spaathome.com

Floppy Friends Horse Toys Recalled by Toy Investments Due to Violation of Lead Paint Standard

American Scientific Recalls Magnets Due to Violation of Lead Paint Standard

Sure Grip Paint Brushes Recalled by Early Childhood Resources Due to Violation of Lead Paint Standard

Disney Store Recalls Tinker Bell Wands Due to Violation of Lead Paint Standard

Char-Broil Recalls Two-Burner Gas Grills Sold Exclusively at Mills Fleet Farm Stores Due to Fire, Burn 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 until a replacement burner is installed.

Name of Product: Char-Broil Two-Burner Gas Grills Model 463720108

Units: About 400

Importer: Char-Broil LLC, of Columbus, Ga.

Manufacturer: Shenzhen Jinwoniu Trading Company LTD, China

Hazard: On the recalled grills, the main burner does not fit correctly and does not connect properly to the gas valve which could result in a propane leak. This poses fire and burn hazards to consumers.

Incidents/Injuries: None reported.

Description: This recall involves the Char-Broil gas grills with model number 463720108 and serial number ranging from 000001 to 000402. The gas grills have a main burner with two-burner plates, a 170 square inch swing-away rack, two side shelves and a condiment basket. Char-Broil's logo is on the top of the lid of the grill. The serial and model numbers are located on the white rating label on the back of the horizontal support of the grill.

Sold at: Mills Fleet Farm Stores in Iowa, North Dakota, Minnesota and Wisconsin from February 2008 through April 2008 for about $120.

Manufactured in: China

Remedy: Consumers should stop using the grill immediately and contact Char-Broil for a free replacement burner and installation instructions.

Consumer Contact: For additional information, contact Char-Broil at (866) 671-7988 between 8 a.m. and 5 p.m. ET Monday through Friday, or visit the firm's Web site at www.charbroil.com

West Music Recalls Shaker Guiro Instruments Due to Violation of Lead Paint Standard

United Scientific 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: Various magnets

Units: About 2.35 million

Importer: United Scientific, of Waukegan, Ill.

Hazard: Surface paint on the magnets contains high levels of lead, which violates the federal lead paint standard.

Incidents/Injuries: None reported.

Description: This recall involves magnets listed in the chart below. The model numbers are located on the magnets packaging. Only painted magnets are included in this recall.

Sold by: Independent distributors nationwide from October 1996 through September 2007 for between 50 cents and $15. Distributors sold the products to schools for use in science classes.

Manufactured in: India

Remedy: Consumers should immediately stop using the recalled magnets and contact United Scientific to receive a free replacement magnet.

Consumer Contact: For additional information, contact United Scientific toll-free at (888) 284-8570 between 9 a.m. and 5 p.m. CT Monday through Friday, or email the firm at consumeraffairs@unitedsci.com

Model Number (Number of Magnets in Package): Description

MGTKIT (4): 3 red ring magnets 38mm x 8 mm, 1 four inch red horseshoe magnet

MSET4 (4): 2 red bar magnets 80x15x10mm, 1 small red horseshoe magnet 25mm x 8mm, 1 large red horseshoe magnet 35mm x 15 mm

CBM050 (2): Red bar magnet pair 50mm

CM7907-R (1): ceramic ring magnets 38mm x 8 mm

CM7907-B (blue) (1): ceramic ring magnets 38mm x 8 mm

CM7907-W (white) (1): ceramic ring magnets 38mm x 8 mm

CM7907-PK/2 (red or blue) (1): ceramic ring magnets 38mm x 8 mm

CM7912-R (2): Red ceramic disc magnet 25mm x 5 mm

MBSET6 (6): 75mm long, scored in two places like a candy bar, sold in six different colors

AUM020 (1): Red 2 inch U-shaped magnets

AUM025 (1): Red 1 inch U-shaped magnets

ACM020 (1): Pair of red cylindrical magnets 50mm x 5 mm

ACM050 (2): Pair of red cylindrical magnets 125mm x 10mm

ABM030 (2): Pair of red and blue bar magnets with North (N) & South (S) Poles marked. 3 inches long x 1/2 inch wide

ABM015-E, ABM020, ABM040, ABM060, ABM040, ABM060, ABM010, ABM015 (2): Red bar magnets, lengths range from 1 1/2 inches to 6 inches, some have N & S marking

MNSB04 (1): 4 inch magnetic needle on plastic support. One end of needle is painted red.

MHS020 (1): Red U-shaped magnet, two inches tall

MHS030 (1): Red U-shaped magnet, three inches tall

CMSET1 (6): Ceramic disc magnets, 25mm x 5 mm, sold in six different colors

Disney Store Recalls Pirates of the Caribbean Sleeping Bags Due to Violation of Lead Paint Standard

Thursday, May 22, 2008

American Flame Recalls Fireplaces to Replace Gas Valves Due to Fire and Explosion 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: Fireplace Gas Valves

Units: About 12,000

Manufacturer: American Flame Inc., of Fort Wayne, Ind.

Hazard: Gas can continue to flow into the fireplace pilot light area after the switch has been turned "off," posing a fire or explosion hazard to consumers.

Incidents/Injuries: American Flame has received two reports of incidents involving valve failure and continuous gas flow. No injuries or fires have been reported.

Description: The recall involves American Flame AF-4000 series fireplace gas valves installed in residential fireplaces made by twelve manufacturers under the following brand names: Pacific Energy, Travis Industries, CFM Corporation, Canadian Heating Products, Portland Willamette, Rasmussen, Chimeneas de Columbia, Twin Eagles, FDM, Inca Metals (Savannah Heating), Even Temp, and Valley Comfort. The valves were installed in some but not all fireplaces. Date codes included in the recall include 0622 through 0718. The gas valve model number is located on a label on the bottom of each gas valve. The date code is located above the label.

Sold by: Fireplace retailers and distributors nationwide from September 2006 through July 2007 for between $500 and $2,000 for the fireplaces, with additional costs for installation.

Manufactured in: Taiwan

Remedy: Consumers should immediately stop using the recalled fireplaces and contact their dealer for a free repair. The repair involves replacing the fireplace's valve if it leaks gas in the "off" position when tested by a qualified service technician.

Consumer Contact: For additional information, contact American Flame toll-free at (888) 672-8929 between 9 a.m. and 5 p.m. ET to determine if your fireplace is included in the recall and to arrange for a free repair, or visit the firm's Web site at www.skytechsystem.com

To see this recall on CPSC's web site, including pictures of the recalled product, please go to:
http://www.cpsc.gov/cpscpub/prerel/prhtml08/08277.html

Wednesday, May 21, 2008

Douglas Co. Recalls Children's Blankets Due to Strangulation 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: Lil' Snugglers(tm) Children's Blankets

Units: About 74,000

Manufacturer: Douglas Co., of Keene N.H.

Hazard: The blanket's satin edge can come loose, posing a strangulation hazard.

Incidents/Injuries: The firm has 18 reports of the satin separating from the blanket. No injuries have been reported.

Description: The recalled children's blankets are 14 inches square with an animal head sewn in the middle. The satin border around the outside edge is about one inch wide. The blankets were sold in the following styles:

Style Number Description

(Only blankets with a P.O. number of 1330 or below are included in this recall)

1327 Cream Lamb
1328 Cream/Tan Horse
1329 Green Frog
1330 Pink Horse
1331 Blue Bear
1332 Yellow Giraffe
1333 Tan Pup
1339 Yellow Duck
1341 Brown Monkey
1351 Pink Bear

The style number, followed by the P.O. number, is identified on a white tab sewn into the blankets behind the Douglas red label.

Sold by: Specialty stores nationwide and on the Web from April 2005 through December 2007 for about $12.

Manufactured in: China

Remedy: Consumers should take the blankets away from children immediately and return it to Douglas for a free replacement blanket or credit toward another item of equal value.

Consumer Contact: For additional information, contact Douglas Co. at (800) 992-9002 between 9 a.m. and 5 p.m. ET Monday through Friday, or visit the firm's Web site at www.douglastoys.com, or email the firm at linda@douglastoys.com

To see this recall on CPSC's web site, including pictures of the recalled product, please go to:
http://www.cpsc.gov/cpscpub/prerel/prhtml08/08275.html

The Home Depot Recalls Candle Holders Due to Fire Hazard

K2 Sports Recalls Snowboard Bindings Due to Fall Hazard

Tuesday, May 20, 2008

Master Toys & Novelties Inc. Recalls Little Rider Toys Due to Violation of Lead Paint Standard

Monday, May 19, 2008

Medicis Announces Voluntary Recall of Solodyn® (minocycline HCL, USP) 90 Mg Tablets, Extended Release

Medicis Announces Voluntary Recall of Solodyn® (minocycline HCL, USP) 90 Mg Tablets, Extended Release; Lot Numbers B080037 and B080038 Due to Product Mix-Up

Medicis today (May 16, 2008) announced that the Company is voluntarily recalling lot numbers B080037 (Exp: 12/09) and B080038 (Exp: 12/09) of the antibiotic SOLODYN® (minocycline HCl, USP) Extended Release Tablets, 90 mg, 30-count bottles (NDC 99207-461-30).

Medicis has received a report that one bottle in lot number B080037 contains AZASAN® (azathioprine tablets) 75 mg (NDC 65649-231-51) instead of SOLODYN® (minocycline HCl, USP) Extended Release Tablets, 90 mg. AZASAN® is an immuno-suppressive agent used in transplant patients to prevent kidney rejection and for the treatment of rheumatoid arthritis. Taking AZASAN® instead of SOLODYN® presents a health hazard and safety risk to patients. Side effects associated with the use of AZASAN®, particularly in the elderly, include mylosuppression (decrease in the number of red and white blood cells and platelets), infection, bleeding, chills, nausea, vomiting and diarrhea. Joint and muscle pain are also common side effects. Unanticipated interactions with other drugs may also lead to serious adverse events. SOLODYN® is manufactured by AAIPharma, Inc. under contract to Medicis. The two lots were manufactured during February 2008. The recall is limited to these lots, and ample supplies of SOLODYN® remain on the market.

Any inquiries related to this recall should be addressed to Stericycle Customer Service at 1-888-656-6381 with representatives available Monday through Friday, 8 a.m. to 11 p.m. EST. For any medical information inquiries or to report an adverse event related to this recall, contact Medicis at 1-800-900-6389 with representatives available 24 hours a day, 7 days a week.

Health care professionals may continue to prescribe the Medicis brand SOLODYN®.

This recall is being conducted in cooperation with the contract manufacturer of the products and with the knowledge of the FDA.

Any adverse reactions experienced with the use of this product, and/or quality problems, also may be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

SOLODYN is a registered trademark of Medicis Pharmaceutical Corporation. AZASAN is a registered trademark of AAIPharma, Inc.

Friday, May 16, 2008

FDA Obtains Permanent Injunction Against Scientific Laboratories, Inc.

The U.S. Food and Drug Administration (FDA) today announced that Scientific Laboratories Inc., and its president, Rajeshwari Patel, and chief executive officer, Amit Roy, have signed a Consent Decree of Permanent Injunction and are barred from manufacturing and distributing drug products until they bring their manufacturing operations into compliance with law and obtain approval for their products.

Scientific Laboratories is a contract manufacturer and distributor of various prescription cough and cold products. The government's complaint, filed by the U.S. Department of Justice, alleged violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The company failed to seek required FDA approval for some of its products and failed to comply with current good manufacturing practice requirements (CGMP).

"The FDA will not allow a company to put the public's health at risk," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research. "These unapproved new drugs have not undergone FDA review for safety and efficacy and may pose potential health risks."

The unapproved new drugs manufactured and marketed by Scientific Laboratories as prescription cough and cold products include: B-Vex Suspension, Ben-Tann Suspension, D-Tann Suspension, D-Tann AT Suspension, D-Tann CT Suspension, D-Tann DM Suspension, D-Tann HC Suspension, Dur-Tann DM Suspension, Duratan DM Suspension, L-All 12 Suspension, Nazarin Liquid, and Nazarin HC Liquid. Because these drugs have not undergone FDA review nor received approval, their safety and effectiveness have not been established. Additionally, the FDA has not reviewed the adequacy and accuracy of the directions and warnings in their labeling.

The FDA had warned Scientific Laboratories against violating the FD&C Act and about the risk of enforcement action if it failed to take corrective measures.

"The FDA will take action against companies and their executives who violate the law and endanger public health," said Margaret O'K. Glavin, associate commissioner for Regulatory Affairs. "The FDA will carefully monitor the provisions of this injunction as well as investigate and take action against other marketers of unapproved drugs."

The consent decree bars the defendants from manufacturing and distributing any drug until they obtain required FDA approval and fully comply with CGMP requirements. The defendants must destroy their illegal drugs. The consent decree also allows the FDA to order the defendants to shut down in the event of future violations. It also subjects the defendants to liquidated damages in the amount of $5,000 per day if they fail to comply with any of the provisions of the decree, and an additional sum of $5,000 for each violation, up to $1 million per year.

If patients have these products in their homes, they should discuss with their health care provider whether to discontinue use of the products and to find alternative therapy. Pharmacies should discontinue dispensing these products.

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 CPG also explains that FDA may take action against manufacturers and marketers of unapproved drugs that violate other provisions of the FD&C Act, including CGMP requirements.

The decree was signed Thurs., May 8, 2008 by Judge William D. Quarles, Jr., in the U.S. District Court for the District of Maryland.

For more information:

FDA's ongoing efforts on marketing unapproved drugs

CDER's Web page on Compliance with Current Good Manufacturing Practices

FDA Shuts Down Seafood Processing Company, Requires Products Be Recalled

The U.S. Food and Drug Administration today directed Hope Food Supply Inc., a Pasadena, Texas, food processing company, to shut down and immediately recall all products manufactured from its Texas facility since 2007.

The company, under a different name, had manufactured dried smoked catfish steaks and other smoked seafood products and had been subject to a consent decree of permanent injunction requiring it to develop and implement an adequate Hazard Analysis and Critical Control Point (HACCP) plan for its fish and fishery products. The firm had not developed this plan. The company cannot restart manufacturing until they have implemented an FDA-approved HACCP plan.

"We simply will not allow a company to put the public's health at risk by not implementing adequate procedures and plans to produce safe food," said Margaret O'K. Glavin, associate commissioner for regulatory affairs. "The FDA will take action against companies and against their executives who violate the law and endanger public health."

The FDA's HACCP regulations require that all seafood processors develop and implement adequate HACCP plans that identify all food safety hazards that are likely to occur for each kind of seafood product that they process, and set forth preventative measures to control those hazards.

The HACCP violations documented by the FDA pose a public health hazard because, without adequate controls, Hope Food Supply's seafood products could harbor pathogenic bacteria such as Staphylococcus aureus and Listeria monocytogenes. Food products with these kinds of pathogens can cause serious illnesses in people who eat them.

The company's products have been distributed nationwide. The FDA is advising consumers who bought smoked seafood products to check with the place of purchase to determine if the products came from Hope Foods. If so, consumers should throw the products out by placing them in a trash receptacle.

Consumers who have been eating Hope Seafood Supply's dried smoked catfish or other smoked seafood products and have experienced adverse reactions should consult their health care professional. Consumers and health care professionals can also report adverse events to the FDA consumer complaint coordinator in their geographic area. Contact numbers may be found online at www.fda.gov/opacom/backgrounders/complain.html.

For more information, consumers can call the FDA's toll-free Food Safety Hotline at 1-888-SAFEFOOD.

Window Falls Prompts CPSC to Issue Warning

With the arrival of the warmer spring weather, families across the nation are
opening their windows to let the fresh air in. This pleasant feeling can quickly
turn tragic in households with small children. In recent weeks, several children
have fallen from windows. The U.S. Consumer Product Safety Commission is warning
parents and caregivers to take precautions to keep children from falling from
windows.

"CPSC staff is aware of at least 18 falls from windows through media reports,
including two deaths, involving small children since April," said CPSC Acting
Chairman Nancy Nord. "We are issuing this warning so parents will take the
necessary steps to prevent these incidents from happening."

These deaths and injuries frequently occur when kids push themselves against
window screens or climb onto furniture located next to an open window.

From 2002-2004, CPSC staff received an average of 25 reports a year of fatalities a
ssociated with falls from windows. Children younger than five years of age account
for approximately one-third of these reported fatalities. For all age categories,
more males died from window falls than females.

To help prevent injuries and tragedies, CPSC recommends the following safety tips:

* Safeguard your children by using window guards or window stops.

    * Install window guards to prevent children from falling out of windows.
(For windows on the 6th floor and below, install window guards that adults and
older children can open easily in case of fire.)

    * Install window stops so that windows open no more than 4 inches.

* Never depend on screens to keep children from falling out of windows.

* Whenever possible, open windows from the top -- not the bottom.

* Keep furniture away from windows, to discourage children from climbing near
windows.

To see this release on CPSC's web site, please go to:
http://www.cpsc.gov/cpscpub/prerel/prhtml08/08270.html

Shindaiwa Corp. Recalls Backpack Blowers Due to Laceration and Impact 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: Shindaiwa Backpack Blowers

Units: About 23,000

Importer: Shindaiwa Corp., of Tualatin, Ore

Manufacturer: Shindaiwa Kogyo Co. Ltd, of Hiroshima, Japan

Hazard: The blower's impeller (fan) can separate from the base and break apart,
causing plastic pieces to be blown out of the machine, and pose a laceration and
impact hazard to consumers. The flying pieces also can cause property damage and
injury to bystanders. Note: These backpack blowers were previously recalled due to
a fire hazard.

Incidents/Injuries: Shindaiwa is aware of 13 incidents involving broken impellers.
One incident involved a minor head injury and minor property damage to a nearby
automobile.

Description: This recall involves Shindaiwa Models EB8510 and EB8510RT. All models
up to serial # 7014728 are included. The backpack blowers weigh approximately 24
pounds and include Serial Numbers through February 2007 production (S/N 702XXXX)
which are located on the side label. These machines are black and blue with a red
and black label that reads, "EB8510, Shindaiwa."

Sold by: Shindaiwa dealers nationwide from September 2005 through January 2007 for
about $600.

Manufactured in: Japan

Remedy: Consumers should stop using the backpack blowers immediately and contact
Shindaiwa for the closest dealer location to schedule a free inspection and impeller
replacement. Consumers who have registered their equipment should have already
received correspondence from Shindaiwa about this recall.

Consumer Contact: For additional information, contact Shindaiwa at (800) 521-7733
between 8:00 a.m. and 4:30 p.m. CT Monday through Friday, or visit the firm's Web
site at www.shindaiwa.com

To see this recall on CPSC's web site, including pictures of the recalled product,
please go to: http://www.cpsc.gov/cpscpub/prerel/prhtml08/08271.html

Fuel Cells Used With Framing Nailers Recalled by Paslode for 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: "Tall Red" Fuel Cells

Units: About 86,000

Manufacturer: Paslode, of Vernon Hills, Ill

Hazard: The fuel cells used to power cordless framing nailers can leak fuel,
posing a fire hazard.

Incidents/Injuries: None reported.

Description: This recall involves "Tall Red" fuel cells designed for use in Paslode
cordless framing nailers. The fuel cells have part number 81600 printed in the upper
right hand corner of the product's packaging. The recalled fuel cells have the
following date and manufacture codes.

Best-Use-Before Dates - located at the bottom of each fuel cell:
09 AUG 2009 10 AUG 2009 11 AUG 2009

Manufactured Dates - located on the outside of master cartons:
11 FEB 2008 12 FEB 2008 13 FEB 2008

Sold at: Construction supply and home center stores and by construction supply
dealers nationwide from February 2008 through April 2008 for between $11 and $14.

Manufactured in: United States

Remedy: Consumers should immediately stop using the fuel cells and return them to
the place of purchase for a full refund or credit.

Consumer Contact: For additional information, contact Paslode at (800) 222-6990
between 7 a.m. and 4:45 p.m. CT Monday through Friday, or visit the firm's Web
site at www.paslode.com (PDF). Consumers can also email the firm at
productsupport@paslode.com

To see this recall on CPSC's web site, including pictures of the recalled product,
please go to: http://www.cpsc.gov/cpscpub/prerel/prhtml08/08269.html

Manhattan Group 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: Tumble Tower Infant Rattles

Units: About 7,000

Manufacturer: Manhattan Group LLC, of Minneapolis, Minn.

Hazard: The blue plastic end caps of the rattle can break, resulting in small parts,
posing a choking hazard to young children.

Incidents/Injuries: Manhattan Group has received two reports of the blue plastic
end caps breaking. No injuries have been reported.

Description: The recalled Manhattan Toy(tm) baby rattle is 5 inches long and made
of clear plastic with blue end cap pieces. The two clear handles feature colorful
beads inside and brightly colored rings on the outside. A blue face spins on a
purple post inside the rattle center when it is turned.

Sold at: Gift and specialty stores nationwide, mail order catalogs, and the Internet
from September 2007 through April 2008 for about $15.

Manufactured in: China

Remedy: Consumers should take the toys away from young children and return them to
the store where purchased for a refund or contact Manhattan Group to exchange the
rattles for another toy.

Consumer Contact: For additional information, contact Manhattan Group toll-free
at (800) 541-1345 between 8 a.m. and 5 p.m. CT, Monday through Friday or visit the
firm's Web site at www.manhattantoy.com

To see this recall on CPSC's web site, including pictures of the recalled product,
please go to: http://www.cpsc.gov/cpscpub/prerel/prhtml08/08268.html

Maple Chase Co. Recalls Carbon Monoxide and Carbon Monoxide/Smoke Combo Alarms Due to Alarm Malfunction

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: FireX Branded 10000 Series Carbon Monoxide (CO) Alarms and
12000 Series CO/Smoke Combo Alarms

Units: About 280,000

Manufacturer: Maple Chase Company, of Plain City, Ohio

Hazard: The recalled alarms can sound a "double chirp"/fault alarm in the presence
of CO, prior to going into full alarm. Upon hearing a double chirp, the Owner's
Manual instructions recommend a consumer take the alarm out of service, which
could expose consumers to hazardous levels of CO and suffer injury or death.

Incidents/Injuries: None reported.

Description: The recall includes FireX branded 10000 and 12000 series alarms with
item numbers: 10000, 12000, 12000C, 12000-6, 12200, 12220, 12400, 12400C manufactured
between June 1, 2007 and February 1, 2008. The date code appears on the back of the
unit with a four digit year, three digit month followed by the day (ex: 2007JUN1 for
June 1, 2007). Units with a manufacture date code prior to June 1, 2007 are not
included in this recall.

Sold: Commercial electrical distributors and electrical contractors and builders
for installation into new home construction. A limited number of units were sold at
Menard's nationwide from June 2007 through February 2008 for about $20 (10000 series)
and $30 (12000 series).

Manufactured in: Mexico

Remedy: Consumers should contact Maple Chase immediately to receive a free comparable
replacement alarm and make arrangements to return their recalled alarms. Consumers
should not take the alarms out of service until they receive the replacement alarm.

Consumer Contact: For more information, contact Maple Chase toll-free
at (888) 879-3906 between 8 a.m. and 6 p.m. CT Monday through Friday or go to the
firm's Web site at www.firexsafety.com

To see this recall on CPSC's web site, including pictures of the recalled product,
please go to: http://www.cpsc.gov/cpscpub/prerel/prhtml08/08267.html

Maran Inc. Children's Hooded Jackets with Drawstrings Recalled Due to Strangulation Hazard; Sold Exclusively at TJ Maxx

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: Squeeze Kids Girl's Corduroy Jackets

Units: About 6,000

Distributor: Maran Inc., of North Bergen, N.J.

Hazard: The garments have a drawstring through the hood, which can pose a
strangulation hazard to children. In February 1996, CPSC issued guidelines (pdf)
to help prevent children from strangling or getting entangled on the neck and waist
drawstrings in upper garments, such as jackets and sweatshirts.

Incidents/Injuries: None reported.

Description: The recalled garments are brown corduroy jackets with a pink hood and
pink sequins on the front pockets. "Squeeze Kids" and style number 4JZ642FK are
printed on the care label sewn into the back collar area of the garment. The
sweatshirts were sold in girls' sizes small (7/8), medium (10), large (12/14)
and x-large (16).

Sold exclusively at: TJ Maxx retail stores nationwide during January 2007 for
about $13.

Manufactured in: China

Remedy: Consumers should immediately remove the drawstrings from the sweatshirts
to eliminate the hazard, or return the garments to the place where purchased or
to Maran Inc. to receive a refund.

Consumer Contact: For additional information, contact Maran Inc. toll-free at
(866) 431-5698 between 9 a.m. and 5 p.m. ET Monday through Friday, or visit the
firm's Web site at www.Sqz.com

To see this recall on CPSC's web site, including pictures of the recalled product,
please go to: http://www.cpsc.gov/cpscpub/prerel/prhtml08/08266.html

Atrium Initiates Voluntary Recall Action Regarding HYDRAGLIDE™ Brand Heparin-Coated Thoracic Drainage Catheters used for Autotransfusion during Cardio

Atrium Medical Corporation today (May 15, 2008) announced that it is initiating a voluntary and precautionary recall of selected lots of HYDRAGLIDE™ Brand Heparin-Coated Thoracic Drainage Catheters. Limited lots of Atrium heparin-coated Hydraglide Thoracic Catheters were manufactured with heparin found to have been contaminated with oversulfated chondroitin sulfate (OSCS). The patient risk associated with the presence of OSCS in heparin-coated medical devices is not known at this time. The U.S. Food and Drug Administration has received reports of serious injury and death in patients who have been administered injectable heparin products containing high levels of OSCS. While Atrium’s HYDRAGLIDE Catheters do not contain high levels of heparin, there still exists a potential exposure of OSCS to the patient.

Customers with affected lots are advised to immediately discontinue use of these devices and obtain replacement catheters from Atrium. Atrium will be working with our customers to replace the affected product as soon as possible. If a non-elective procedure requires use of this catheter, we recommend that you do not use the catheter with either a cell saver autotransfusion system or direct autotransfusion chest drainage collection system for cardiopulmonary bypass surgery.

Atrium has not received reports of any OSCS-related adverse events arising from any use of their Hydraglide Thoracic Catheters. This voluntary recall is being initiated as a precaution to minimize any future potential risk.

The above Customer Notification actions are being taken with the knowledge of the U.S. Food and Drug Administration. Physicians and hospital personnel with product related questions should call the company at 1-800-5-ATRIUM, Monday –Friday, 8:00 AM to 5:00 PM EST.

Thursday, May 15, 2008

Sweetwater Valley Farm, Inc. Recalls Tennessee Aged Black Pepper Cheese

Sweetwater Valley Farm, Inc. of Philadelphia, TN is recalling Tennessee Aged Black Pepper Cheese because it has 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.

Tennessee Aged Black Pepper Cheese, Lot Number 616-361 was distributed in 5, 7, and 10 ounce bars through our retail store in Philadelphia, TN and a Winery in Portland, TN.

Less than 100 pounds was distributed.

This product was distributed between December 27, 2007 and May 12, 2008.

No illnesses have been reported.

The recall was the result of a routine sampling program by the Tennessee Department of Agriculture which revealed that the finished product contained the bacteria. The company has ceased the distribution of this lot as the company continues their investigation as to what caused the problem.

Consumers who have purchased lot number 616-361 of this product are urged bring it to the store for replacement or refund or ship it back to the store for replacement or refund. Contact the company’s consumer affairs department at 1-877-862-4332 for further information.

Wednesday, May 14, 2008

Manufacturer Removes Remaining Stocks of Trasylol

Background: On Nov. 5, 2007, the U.S. Food and Drug Administration announced that Bayer Pharmaceuticals Corp. agreed to an FDA-requested marketing suspension of Trasylol, a drug used to control bleeding during heart surgery. At that time, preliminary results from a Canadian study suggested an increased risk for death compared to two other drugs used to control bleeding.

Bayer HealthCare Pharmaceuticals Inc. has notified the FDA that the company will begin removing the remaining Trasylol stock from the U.S. market, most of which is in warehouses and hospital or physician’s stock. The FDA will work with Bayer to ensure a smooth and complete process.

Under a limited use agreement, access to Trasylol is limited to investigational use of the drug according to the procedures described in a special treatment protocol. The protocol allows treatment for certain patients who are at increased risk of blood loss and transfusions during coronary artery bypass graft surgery and who have no acceptable alternative therapy. Physicians using Trasylol in this situation must also verify that the benefits of the drug clearly outweigh the risks for their patients.

FDA limits access to certain drugs to patients with serious or immediately life-threatening disease or conditions who lack other therapeutic options and may benefit from such therapies. This type of access requires the submission of a protocol, which is reviewed and approved by the agency. Bayer has agreed to provide Trasylol through this mechanism for the limited use described above.

Trasylol is an antifibrinolytic drug approved to reduce blood loss during surgery and the need for blood transfusion in certain patient undergoing cardiopulmonary bypass in the course of coronary artery bypass graft surgery. Antifibrinolyitc drugs help slow the breakdown of blood clots and subsequent excessive bleeding.

Results from a randomized Canadian study that prompted last November’s marketing suspension of Trasylol are expected to be published this week. The data contained in this article suggest that Trasylol appears to increase the risk for death compared to two other antifibrinolytic drugs used in the study.

The findings from this randomized study are similar to those from an observational study that was discussed at a September 2007 FDA advisory committee meeting. Based upon the data available at the time, the advisory committee recommended continued marketing of Trasylol.

However, FDA requested the marketing suspension in the interest of patient safety based on the serious nature of the outcomes suggested in the preliminary data. The committee also advised that a large, randomized clinical study was needed to further assess Trasylol’s safety compared to other drugs. This recently published Canadian study helps address this need for additional information.

The FDA has not yet received full study data from the study’s researchers at the Ottawa Health Research Institute but supports Bayer’s decision to completely remove Trasylol from regular use in the U.S. market. FDA is also reviewing the available Canadian study data to reassess the currently active special treatment protocol that provides access to Trasylol.

FDA oversight requires comprehensive and thorough studies of a drug not only during the pre-market review phase but throughout the drug’s life cycle. As studies and data on Trasylol emerged over the years, FDA actions included labeling changes, safety communications to physicians and other health care professionals, public discussion and review of study data at two Advisory Committee meetings, as well as close scrutiny of the ongoing studies.

The agency will consider a variety of study designs to support the review process for future antifibrinolytics, and will incorporate into these considerations information from the recently published Canadian study. FDA will continue to publicly disseminate safety information.

Medtronic Initiates Voluntary Field Actions for Selected Heparin-Coated Products Used During Cardiopulmonary Bypass

Medtronic, Inc. today (May 7, 2008) announced that it is initiating a voluntary and precautionary recall of selected products featuring the Carmeda BioActive surface. The affected devices are disposable products used during cardiopulmonary bypass (CPB) for heart surgeries. Affected products include blood oxygenators, reservoirs, pumps, cannulae, and tubing packs. This action is being taken subsequent to the U.S. Food and Drug Administration's April 8, 2008 recommendation to device manufacturers that heparin supplies be checked with newly-developed tests, and that affected products be evaluated for possible field corrective action.

Limited lots of Carmeda-coated products were manufactured with heparin found to have been contaminated with oversulfated chondroitin sulfate (OSCS). The patient risk associated with the presence of OSCS in heparin-coated medical devices is not known at this time. However, the U.S. Food and Drug Administration has received reports of serious injury and death in patients who have been administered injectable heparin products containing high levels of OSCS.

Medtronic has not received reports of any OSCS-related adverse events arising from the use of Carmeda CPB products. It is unclear, however, if exposure to Carmeda-coated medical devices, made with comparatively small amounts of heparin, could cause adverse events similar to those observed with injectable heparin formulations. As a result, Medtronic has initiated a precautionary recall of affected Carmeda products.

In a separate action, Medtronic is advising customers that selected lots of Trillium-coated products were also manufactured with heparin containing OSCS. Trillium is another biosurface used on CPB products. The amount of heparin on the product is significantly lower than that contained on the Carmeda product. Medtronic's ultimate goal is to remove contaminated products from the market. However, based on the current data, the benefit of using the affected products outweighs any potential risk to patients. Since the maximum possible patient exposure to heparin from Trillium is extremely low, customers can continue to use the affected Trillium products until a replacement is available.

The above actions are being made with the knowledge of the U.S. Food and Drug Administration. Patients with questions should talk to their physician. Physicians or Pefusionists with medical questions related to Medtronic therapies should contact Medtronic at 1-800-638 0218, Monday – Friday, 8:00 a.m. to 5:00 p.m. CDT

Air Pistols That Can Fire Unexpectedly Are Recalled by Umarex USA

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: Air Pistols

Units: About 7,250

Distributor: Umarex USA Inc., of Fort Smith, Ark.

Manufacturer: DianaWerk GmbH & Co., of Rastatt, Germany

Hazard: The air pistols can accidentally discharge, posing a risk of serious injury
if the air pistol is loaded and pointed at the user or another person when it
discharges.

Incidents/Injuries: Umarex USA has received one report of an injury involving the
recalled air pistols. The pistol reportedly fired a pellet unexpectedly and struck
the user in the lower leg causing swelling.

Description: The recall involves the RWS-5G Magnum Air Pistol. The air pistols,
which are used for target and recreational shooting, use spring air to fire pellets.
The air pistols are black and measure 17 ¾ x 6 inches. "RWS Diana P5 Magnum" is
printed on the top of the air pistol. Serial numbers 03316930 through 03344312 are
included in this recall and are stamped on the left side of the air pistol's barrel.

Sold by: Sporting goods stores and gun shops nationwide from July 2006 through
February 2008 for about $250.

Manufactured in: Germany

Remedy: Consumers should immediately stop using the recalled air pistols and
contact Umarex USA to receive instructions on returning the air pistol for a free
repair. Umarex USA has contacted known purchasers of the air pistol. Consumers who
have not received direct notification should contact Umarex USA immediately.

Consumer Contact: For additional information, contact Umarex USA toll-free at
(866) 633-2910 anytime, or visit the firm's Web site at www.umarexusa.com

To see this recall on CPSC's web site, including pictures of the recalled product,
please go to: http://www.cpsc.gov/cpscpub/prerel/prhtml08/08265.html

Friday, May 9, 2008

Baby Bottle and Food Warmers Recalled by Munchkin 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: Deluxe Bottle and Food Warmers

Units: About 5,000

Manufacturer: Munchkin Inc., of North Hills, Calif.

Hazard: The bottle and food warmers can overheat, posing a fire hazard.

Incidents/Injuries: Munchkin has received nine reports of units
overheating, several of which ignited, causing damage to countertops. No
injuries have been reported.

Description: This recall involves the Munchkin Deluxe Bottle and Food
Warmer with Pacifier Cleaning Basket 2-in-1 Design, model #13301 and lot
number TP-1487. The product is used to warm food and bottles of various
sizes. The set includes a main basket, a lift-out basket, an adapter
ring, and a measuring cup. "Munchkin" is located on the front of the
warmer and "TP-1487" is located on the bottom. Only warmers bearing lot
number "TP-1487" are included in this recall.

Sold at: Various retailers nationwide and company's catalog from June
2007 through April 2008 for about $20.

Manufactured in: China

Remedy: Consumers should stop using bottle and food warmers with lot
number TP-1487 immediately and contact Munchkin to receive a free
replacement.

Consumer Contact: For additional information, contact customer service
toll-free at (866) 619-8673 between 9 a.m. and 5 p.m. PT Monday through
Friday, or visit the firm's Web site at www.munchkin.com

To see this recall on CPSC's web site, including pictures of the
recalled product, please go to:
http://www.cpsc.gov/cpscpub/prerel/prhtml08/08263.html

Wednesday, May 7, 2008

Blount Fine Foods Issues Allergy Alert On Undeclared Shrimp in All Natural New England Clam Chowder, 20 Oz Cup

Blount Fine Foods of Fall River, MA is recalling Blount All Natural New England Clam Chowder, Net Wt. 20 oz with Lot: 0424086D, Sell by date: 6/23/2008, because it may contain undeclared shrimp. People who have an allergy or severe sensitivity to shrimp run the risk of serious or life-threatening allergic reaction if they consume these products. Our firm has recovered 1,400 of 1,416 units produced, 16 units are in distribution.

Blount New England Clam Chowder was distributed through the following supermarket chains: Shaw's Supermarkets (in Massachusetts and Connecticut), Omni Foods (in Weston, MA), Donelan Market (in Acton and Littleton, MA), and The Cirelli Marketplace store (Middleboro, MA). The product is identified as a 20oz plastic cup with a film seal and plastic lid. The dark blue product label reads: Blount Signature Soups All Natural New England Clam Chowder, Keep Refrigerated. The lot code and sell by date are printed in black ink on the bottom of the cup.

No illnesses have been reported to date. The recall was initiated after it was discovered that product containing shrimp was distributed in packaging that did not reveal the presence of shrimp. Subsequent investigation indicates the problem was caused by an isolated, temporary breakdown in the company's production and packaging processes.

Consumers who have purchased Blount All Natural New England Clam Chowder are urged to return it to the place of purchase for a full refund. Consumers who have health-related concerns should contact their physician. Consumers with questions may contact the company at 1-800-274-2526.

TJ Power Sports Recalls Dune Buggies Due To Ejection 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 shouldstop using recalled products immediately unless otherwise
instructed.

Name of Product: Twister Hammerhead Dune Buggies

Units: About 400

Importer: TJ Power Sports LLC, of Irving, Texas

Hazard: The seat belt adjustment for the shoulder buckle can break during impact
or stress, posing an ejection and injury hazard to driver and passenger.

Incidents/Injuries: TJ Power Sports has received one report of a seat belt
breaking that resulted in nerve damage to the rider's right arm.

Description: This recall involves the dune buggies "Twister Hammerhead" with model
number UM150IIR and model year 2004. The dune buggies were available in red, blue,
or green. "Twister Hammerhead", the model number, and the model year can be found
imprinted on the bar behind the driver and passenger seats.

Sold through: Twister dealers nationwide and online retailers from July 2004
through December 2004 for about $3,000.

Manufactured in: China

Remedy: Consumers should stop using these dune buggies immediately and contact
TJ Power Sports for instructions on how to receive a replacement seat belt.

Consumer Contact: For additional information, visit the firm's Web site
www.tjpowersports.com

To see this recall on CPSC's web site, including a picture of the recalled
product,please go to:
http://www.cpsc.gov/cpscpub/prerel/prhtml08/08262.html

Tuesday, May 6, 2008

Updated: Lezza Blue Raspberry Italian Ice Recalled

RR Note: Please note several additional states, including Georgia, have been added to the list.

Cedar Crest Specialties, Inc., Manitowoc, Wisconsin announced on Friday, May 2nd 2008 a recall on one lot code of Lezza Blue Raspberry Italian Ice because, it may contain milk allergen protein that is not listed in the product’s ingredient statement. People who have an allergy or severe sensitivity to milk may experience a potentially serious or life-threatening allergic reaction if they consume this product.

The product is in round plastic pint containers with a lot code of 2116. Blue Raspberry is the flavor of the product.

The product was distributed to retail outlets in Illinois, Wisconsin, Oklahoma, Texas, Michigan, Louisiana, Kansas, Indiana, Georgia, Florida, Ohio, Missouri, Kentucky, Nebraska, Pennsylvania, Arkansas, and Minnesota during 2006 and 2007.

There is no health risk for consumers who are not allergic to milk.

No other Lezza Italian Ice products are included in this recall. The product is flavored frozen water ice and must be kept frozen.

There is one reported allergic reaction attributed to this product. After customer reported allergic reaction, product in customer’s possession was retrieved and sent to independent lab for analysis. Unopened product was also sent to independent lab for testing. Decision for recall was reached after lab tests were completed. Only one complaint was filed about lot code 2116.

Concerned consumers are encouraged to return any affected product to the place of purchase to receive a full refund. Consumers with questions or concerns may contact Cedar Crest Specialties, Inc. at 1-866-233-2788.

Hydrox Labs Issued a Voluntary Recall of Alcohol-Free Mouthwash Nationwide Distributed by Cardinal Health

Hydrox Labs, Elgin, IL has issued a voluntary recall of Cardinal Health labeled alcohol-free mouthwash. As a result of this recall, Cardinal Health is initiating a voluntary recall of the same alcohol-free mouthwash. The FDA has been apprised of the action. The mouthwash has been tested and been found positive for Burkholderia cepacia (B. cepacia). The CDC has confirmed hospital illnesses in one state associated with the use of the affected mouthwash.

Product was distributed to hospitals, medical centers, and long term care facilities nationwide.

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. B. cepacia bacteria are often resistant to common antibiotics. 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 recall includes the following products:

Description	Reorder Number
Alcohol-Free Mouthwash, Cardinal Health, 4 oz.	AG-210

Product lot number 26228 is affected. Affected product can be identified by checking the lot code stamped on the Cardinal Health label. The Lot number is located on the side of the bottle.

The mouthwash may also be found in certain Personal Hygiene Hospital Admission Kits. If you received mouthwash labeled for Cardinal Health from your healthcare provider, please check to see if the reorder number on the label matches the recalled reorder numbers listed above, then check to see if the lot number matches the recalled lot number.

Customers who have Cardinal Health labeled alcohol free mouthwash which is being recalled should stop using the product and contact Cardinal Health for instructions.

Cardinal Health is notifying their customers via overnight mail and is arranging for all product to be returned for credit.

Monday, May 5, 2008

Onward Manufacturing Recalls Gas Grills Due to Fire and Burn 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: Broil King Gas Grills

Units: About 4,800

Manufacturer: Onward Manufacturing Co., of Ontario, Canada

Hazard: The bottom of the cook box that contains the burners can melt or crack as a
result of a grease fire. This poses a fire and burn hazard to consumers.

Incidents/Injuries: None reported

Description: This recall includes the Signet, Sovereign and Sovereign XL series gas
grills.

Signet series: (model #'s starting with 986xxx) 400 sq. inch cooking surface with
3 burners and drop-down shelves; includes models with side and rear burners

Sovereign series: (model #'s starting with 987xxx) 450 sq. inch cooking surface with
3 burners and drop-down shelves; includes models with side and rear burners.

Sovereign XL series: (model #'s starting with 988xxx) 600 sq. inch cooking surface
with 4 burners and drop-down shelves.

The model number can be located on the back panel of the grill.

Sold at: Independent retailers nationwide from February 2006 through April 2008 for
between $450 and $700.

Manufactured in: Canada

Remedy: Consumers should stop using the grill immediately and contact Onward
Manufacturing for a free repair kit.

Consumer Contact: For further information, visit the firm's Web site
at www.broilkingbbq.com or call toll-free at (866) 434-7455 between 8:30 a.m. and
5 p.m. PT Monday through Friday.

Lezza Blue Raspberry Water Ice Recalled from Three Midwestern States

Cedar Crest Specialties, Inc. today announced a recall on one lot code of Lezza Blue Raspberry Water Ice in round plastic pint containers with a lot code of 2116 because it may contain undeclared milk protein. The product was distributed to retail outlets in Illinois, Wisconsin, and Minnesota during 2006 and 2007.

The product is being recalled because it may contain milk allergen protein that is not listed in the product’s ingredient statement. People who have an allergy or severe sensitivity to milk may experience a potentially serious or life-threatening allergic reaction if they consume this product.