Wednesday, July 21, 2010

Vialipro Dietary Supplement: Recalled.

Vialipro Dietary Supplement: Recall-Undeclared Drug Ingredient

[Posted 07/20/2010]
AUDIENCE: Consumers
ISSUE: Good Health, Inc. is conducting a voluntary recall after an FDA lab analyses found that the product tested from certain batches of Vialipro contain Sulfoaildenafil, an analogue of Sildenafil, an FDA-approved drug used as treatment for male Erectile Dysfunction (ED) making this product an unapproved drug. The undeclared ingredient may pose a threat to the consumer because the interaction of the analogue with some prescription drugs (such as nitroglycerin) may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take other prescription drugs.
BACKGROUND: This product is currently being sold as a dietary supplement throughout the U.S.  The affected lot numbers being recalled can be found in the company's Press Release.
RECOMMENDATION: Consumers who have purchased Vialipro should discontinue its use and return it to Good Health, Inc.
Report adverse events or side effects related to the use of this product to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
  • Online: www.fda.gov/MedWatch/report.htm
  • Phone: 1-800-332-1088
  • Mail: return the postage-paid FDA form 3500, which may be downloaded from the MedWatch "Download Forms" page, to address on the pre-addressed form
  • Fax: 1-800-FDA-0178
[07/16/2010 - Press Release - Good Health, Inc.]

Thursday, June 17, 2010

Portland Shellfish Co. Inc, Recalls Cooked, Frozen Claw Island Brand, Craig’s All Natural Brand And Inland Ocean Brand Lobster Claw And Knuckle Meat Because Of Possible Health Risk


Portland Shellfish Company, Inc. is voluntarily recalling the following brands of cooked, ready to eat fresh or frozen lobster meat: Portland Shellfish Co. Inc brand, Claw island, Craig’s All Natural, and Inland Ocean cooked, fresh or frozen lobster claw and knuckle meat as recent tests show the product 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.

Tuesday, May 25, 2010

Nationwide Pool and Spa Safety Campaign Launched By The U.S. Consumer Product Safety Commission (CPSC)


FOR IMMEDIATE RELEASE
May 24, 2010
Release #10-241
CPSC Recall Hotline: (800) 638-2772
CPSC Media Contact: (301) 504-7908

CPSC Launches National Campaign to Change the Way People Think and Act about Pool and Spa Safety

Pool Safely Campaign Aims to Reduce Child Drownings and Entrapments

CPSC, Olympians Hold Press Event to Release New Death and Injury Data

FORT LAUDERDALE, FL - The U.S. Consumer Product Safety Commission (CPSC) today kicks-off the Pool Safely campaign (www.poolsafely.gov), a first-of-its-kind national public education effort to reduce child drownings and non-fatal submersions, and entrapments in swimming pools and spas. At a press conference at the Fort Lauderdale Aquatic Complex today, Olympic swimmers Jason Lezak and Janet Evans joined Inez Tenenbaum, Chairman of the CPSC; U.S. Rep. Debbie Wasserman Schultz (D-FL); and Nancy Baker, mother of Virginia Graeme Baker, to officially launch Pool Safely and release the CPSC's annual submersion and entrapment reports.
Today, CPSC released its annual reports on children's submersion and entrapment incidents which showed:
  • From 2005-2007 there was an annual average of 385 pool and spa-related drownings for children younger than 15; about 78 percent, or 299, of these children were younger than five.
  • From 2007-2009, there were an estimated average of 4,200 pool or spa emergency department-treated submersions for children younger than 15; and children between the ages of 12 to 35 months represented 47 percent of estimated injuries for these years.
  • About 54 percent of the estimated injuries for 2007 - 2009 and 74 percent of the fatalities for 2005 - 2007 involving children younger than fifteen occurred at a residence.
  • Most reported fatalities occurred on the day of (73 percent) or within a week of (additional 23 percent) the submersion incident. Just four percent of fatal victims survived beyond a week of the submersion; these victims had severe injuries and required intensive medical care.
  • There were no reported entrapment fatalities for 2009. CPSC did receive eight reports of entrapment incidents in which seven people were injured during 2009.
For the complete reports see: Pool and Spa Submersions 2010 (pdf) and Circulation/Suction Entrapments 2010 (pdf). The years for reported injury and fatality statistics differ as a result of the lag in fatality reporting.
"It is important to keep in mind that these numbers represent family tragedies. Preventing child drownings year round is a priority for the CPSC," said Chairman Tenenbaum. "The Pool Safely campaign will start a national conversation with parents and children, pool owners and operators and industry professionals about the simple safety steps they can take to protect themselves and their families in and around pools and spas. These incidents are preventable, so our mission is to change the way families think and act about pool and spa safety."
The Pool Safely campaign is a key part of the CPSC's efforts to carry out the requirements of Section 1407 of the Virginia Graeme Baker Pool and Spa Safety Act (P&SS Act), federal legislation signed into law in 2007 mandating new requirements for pool and spa safety. It includes a requirement for a national public education campaign designed to raise public awareness, support industry compliance, and improve safety at pools and spas.
"I have been involved in the issue of pool safety throughout my career and today marks a key milestone in the ongoing fight to reduce accidental drowning," said Congresswoman Debbie Wasserman Schultz, author of the Virginia Graeme Baker Pool and Spa Safety Act. "Educating communities on the potential dangers of swimming pools is a critical tool in saving the lives of our children. I am so pleased to have worked with my colleagues in Congress to provide the funds needed for implementation of this important campaign."
The Pool Safely campaign will deliver an important and simple message: just adding an extra safety step in and around the water can make all the difference. Your greatest water safety assurance comes from adopting and practicing as many water safety measures as possible, including: barriers that completely surround the pool with self-closing, self-latching gates; staying close, being alert, and watching children at the pool; learning and practicing water safety skills (knowing how to swim and perform CPR); and having the appropriate equipment (compliant drain covers, alarms, barriers and sensors).
The campaign will highlight the need to implement a "personal system of safety" that consists of adding as many proven water safety practices as possible in and around pools and spas.
"As a parent of young children, I know there's no single, sure-fire way to ensure their safety around pools and spas," added Janet Evans, five-time Olympic medalist in swimming. "Whether it's enrolling them in swimming lessons or simply watching them at all times, there is always one more thing I can do. The Pool Safely campaign offers a variety of simple steps we can all take to protect our children in pools and spas."
Pool Safely will serve as an information hub delivering campaign tools and resources to various outreach channels. CPSC has taken the lead by partnering with national, regional and local organizations in the children's safety and drowning prevention communities. By engaging key partners, the campaign will reach the widest possible audience and build a sustainable network that will ensure the campaign's messaging is delivered for years to come.
"Knowing how to swim helped me win gold in the water, but it takes adding as many water safety steps as possible to ensure a safe environment for children in and around pools and spas, " said seven-time Olympic medalist in swimming Jason Lezak. "No matter how responsible you already are, there is always one more safety step you can take to protect your child. That is how you can Pool Safely. "
"I understand the need to bring together the public and dedicated partners in the water safety community to begin a national conversation about water safety," said Nancy Baker, the mother of Virginia Graeme for whom the Act is named. "I am honored to be involved in the Pool Safely campaign and look forward to working together to promote additional water safety steps we all can take in protecting our loved ones in and around pools and spas. Simple steps save lives."
The Pool Safely campaign - a national public education effort by the Consumer Product Safety Commission - is proud to partner with leading organizations, including American Red Cross, YMCA of the USA, Safe Kids USA, National Drowning Prevention Alliance (NDPA), World Waterpark Association (WWA), and Abbey's Hope. For more information, visit the website at www.poolsafely.gov or follow the campaign on Twitter @poolsafely

Pelican International Recalls Utility Snow Sled Hitch

Utility Snow Sled Hitch Recalled by Pelican International Due to Injury Hazard

In cooperation with the U.S. Consumer Product Safety Commission, Pelican International, of Quebec, Canada, is voluntarily recalling about 250 Utility sled tow hitches. The screw(s) in the hitch can become loose and fall off du

Brunswick Bowling & Billiards Corporation Recalls Chairs

Chairs Recalled by Brunswick Bowling & Billiards Corporation Due to Fall Hazard

In cooperation with the U.S. Consumer Product Safety Commission, Brunswick Bowling & Billiards Corp., of Lake Forest, Ill., is voluntarily recalling about 750 chairs 830B and 830D Voltaire Swivel Chairs. The chair frame can separate from the seating section of the chair, posing a fall hazard to consumers

Cummins Power Generation Recalls Portable Generators

Cummins Power Generation Recalls Portable Generators Due to Fire Hazard

In cooperation with the U.S. Consumer Product Safety Commission, Cummins Power Generation, of Minneapolis, Minn., is voluntarily recalling about 550 Portable Generators. Fuel can leak through the carburetor during normal usage, posing a fire hazard to consumers.

CPSC Identifies Chinese Manufacturers of Problem Drywall.

CPSC Identifies Manufacturers of Problem Drywall Made in China

The U.S. Consumer Product Safety Commission (CPSC) is releasing today the names of the drywall manufacturers whose drywall emitted high levels of hydrogen sulfide in testing conducted for the agency by Lawrence Berkeley National Laboratory (LBNL). There is a strong association between hydrogen sulfide and metal corrosion.
The following list identifies the top 10 drywall samples tested that had the highest emissions of hydrogen sulfide, along with the identity of the manufacturer of the drywall and the year of manufacture, from highest to lowest.
  • Knauf Plasterboard (Tianjin) Co. Ltd.: (year of manufacture 2005) China
  • Taian Taishan Plasterboard Co. Ltd.: (2006) China
  • Shandong Taihe Dongxin Co.: (2005) China
  • Knauf Plasterboard (Tianjin) Co. Ltd.: (2006) China
  • Taian Taishan Plasterboard Co. Ltd.: (2006) China
  • Taian Taishan Plasterboard Co. Ltd.: (2006) China
  • Shandong Chenxiang GBM Co. Ltd. (C&K Gypsum Board): (2006) China
  • Beijing New Building Materials (BNBM): (2009) China
  • Taian Taishan Plasterboard Co. Ltd.: (2009) China
  • Shandong Taihe Dongxin Co.: (2009) China
.

Tommy Hilfiger U.S.A. Recalls Children's Sweatshirts


FOR IMMEDIATE RELEASE
May 13, 2010
Release #10-233
Tommy Hilfiger's Recall Hotline: (800) 866-6922
CPSC Recall Hotline: (800) 638-2772
CPSC Media Contact: (301) 504-7908
HC Media Contact: (613) 957-2983

Children's Sweatshirts Recalled by Tommy Hilfiger U.S.A. Due to Violation of Federal Flammability Standard

WASHINGTON, D.C. - The U.S. Consumer Product Safety Commission and Health Canada, in cooperation with the firm named below, today announced a voluntary recall of the following products. Consumers should stop using recalled products immediately unless otherwise instructed. It is illegal to resell or attempt to resell a recalled consumer product.
Name of Product: Tommy Hilfiger Sweatshirts
Units: About 400 in the U.S., and 1,300 in Canada
Importer: Tommy Hilfiger U.S.A. Inc., of New York, N.Y.
Hazard: The sweatshirts fail to meet federal flammability standards for wearing apparel, posing a risk of burn hazard to consumers.
Incident/Injuries: None reported.
Description: This recall involves Tommy Hilfiger brand children's sweatshirts sold in sizes 4 to 16. The sweatshirts have the letters "N.Y.C." and "Hilfiger College" printed on the front. Sweatshirts included in this recall were sold in three styles:
PhotoStyle NumberDescription
Picture of Recalled SweatshirtBJ52217867Orange and brown, hooded
sweatshirt with zipper
Picture of Recalled SweatshirtE552217832Orange, brown or black,
hooded pullover sweatshirt
Picture of Recalled SweatshirtE552217830Black zippered sweatshirt
Sold at: Tommy Hilfiger retail stores nationwide, Macy's Herald Square (N.Y.) and at Tommy.com from August 2009 through January 2010 for between $50 and $70.
Manufactured in: Indonesia
Remedy: Consumers should immediately stop using the recalled sweatshirts and contact Tommy Hilfiger to receive a full refund.
Consumer Contact: For additional information, contact Tommy Hilfiger U.S.A. at (800) 866-6922 between 7 a.m. and 12 a.m. ET daily, or visit Tommy Hilfiger's website at www.tommy.com
Note: Health Canada's press release is available at http://cpsr-rspc.hc-sc.gc.ca/PR-RP/recall-retrait-eng.jsp?re_id=1051

LEXUS (Toyota) RECALLS LEXUS LS460 AND LS600 VEHICLES

Vehicle Make / Model:     Model Year(s):
     LEXUS / LS460     2009-2010
     LEXUS / LS460L     2009-2010
     LEXUS / LS600H     2010
     LEXUS / LS600HL     2010
Manufacturer: TOYOTA MOTOR NORTH AMERICA, INC. Mfr's Report Date: MAY 21, 2010
NHTSA CAMPAIGN ID Number: 10V218000 NHTSA Action Number: N/A
Component: STEERING:ELECTRIC POWER ASSIST SYSTEM
Potential Number of Units Affected: 3800
Summary:
 TOYOTA IS RECALLING CERTAIN MODEL YEAR 2009 AND 2010 LEXUS LS460 AND LS600 VEHICLES MANUFACTURED FROM AUGUST 20, 2009 THROUGH MAY 13, 2010. A PROGRAMMING CHANGE OF THE STEERING CONTROL ECU FOR THE VARIABLE GEAR RATIO STEERING (VGRS) SYSTEM CAN CAUSE IMPROPER ACTIVATION OF THE STEERING SYSTEM PROTECTION LOGIC DESIGNED TO PROTECT THE SYSTEM WHEN LARGER THAN NORMAL STEERING INPUTS ARE APPLIED AT A FULLY TURNED POSITION.
Consequence:
 IMPROPER ACTIVATION OF THE STEERING SYSTEM PROTECTION LOGIC CAN CAUSE THE STEERING WHEEL TO BECOME OFF-CENTERED UP TO 90 DEGREES. THIS MAY OCCUR AFTER THE DRIVER HAS FULLY TURNED THE STEERING WHEEL IN ONE DIRECTION THEN QUICKLY ATTEMPTS TO TURN IT BACK TO THE CENTER POSITION. SHOULD THIS OCCUR WHILE DRIVING, THE RISK OF A CRASH IS INCREASED.
Remedy:
 TOYOTA WILL NOTIFY OWNERS AND LEXUS DEALERS WILL REPLACE THE STEERING CONTROL ECU FREE OF CHARGE. TOYOTA HAS NOT DETERMINED WHEN THE SAFETY RECALL IS EXPECTED TO BEGIN. OWNERS MAY CONTACT TOYOTA AT 1-800-331-4331.
Notes:
 OWNERS MAY ALSO CONTACT THE NATIONAL HIGHWAY TRAFFIC SAFETY ADMINISTRATION'S VEHICLE SAFETY HOTLINE AT 1-888-327-4236 (TTY 1-800-424-9153), OR GO TO HTTP://WWW.SAFERCAR.GOV .

Friday, May 21, 2010

NISSAN RECALLS YEAR 2010 TITAN, ARMADA, QX56, FRONTIER, XTERRA, AND PATHFINDER VEHICLES

Vehicle Make / Model:     Model Year(s):
     INFINITI / QX56     2010
     NISSAN / ARMADA     2010
     NISSAN / FRONTIER     2010
     NISSAN / PATHFINDER     2010
     NISSAN / TITAN     2010
     NISSAN / XTERRA     2010
Manufacturer: NISSAN NORTH AMERICA, INC. Mfr's Report Date: MAY 12, 2010
NHTSA CAMPAIGN ID Number: 10V208000 NHTSA Action Number: N/A
Component: STEERING
Potential Number of Units Affected: 41649
Summary:
 NISSAN IS RECALLING CERTAIN MODEL YEAR 2010 TITAN, ARMADA, QX56, FRONTIER, XTERRA, AND PATHFINDER VEHICLES MANUFACTURED FROM NOVEMBER 19, 2009 THROUGH MARCH 3, 2010. THE LOWER CONTROL LINK ASSEMBLY HAS TWO CYLINDRICAL COLLARS FORMING THE INBOARD ATTACHMENT POINTS TO THE CHASSIS. DUE TO AN IMPROPER WELDING PROCESS SOME COLLARS MAY CONTAIN WELDS THAT DO NOT MEET STRENGTH SPECIFICATIONS.
Consequence:
 IF THE COLLAR WELD SEPARATES, THE VEHICLE HANDLING WILL DETERIORATE, POSSIBLY RESULTING IN A VEHICLE CRASH.
Remedy:
 NISSAN WILL NOTIFY OWNERS AND DEALERS WILL REPAIR THE VEHICLES FREE OF CHARGE. THE SAFETY RECALL IS EXPECTED TO BEGIN DURING JUNE 2010. OWNERS MAY CONTACT NISSAN AT 1-800-647-7261.
Notes:
 OWNERS MAY ALSO CONTACT THE NATIONAL HIGHWAY TRAFFIC SAFETY ADMINISTRATION'S VEHICLE SAFETY HOTLINE AT 1-888-327-4236 (TTY 1-800-424-9153), OR GO TO HTTP://WWW.SAFERCAR.GOV .

GA

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