CPSC, Goodman Manufacturing Co. Announce Changes to 1998 Recall Program to Replace Dangerous Home Heating Vent Pipes

CPSC, Goodman Manufacturing Co. Announce Changes to 1998 Recall Program to Replace Dangerous Home Heating Vent Pipes

WASHINGTON, D.C. - The CPSC and Goodman Manufacturing Company, of Houston, TX, are urging consumers who have not yet responded to the previously-announced 1998 recall to do so immediately. After October 1, 2009, the remedy consumers receive will change to be identical to modifications recently announced for a related recall.

The recall included about 10,000 Plexvent and Ultravent HTPV pipe systems attached to certain Goodman mid-efficiency furnaces manufactured from October 1988 to July 1994 (models GUP, GDP, GUPS, GDPS, GUPI, GDPI, GUPX, GDPX, GMP and GMPV for the following brands manufactured by Goodman: Janitrol, GMC, Hamilton Electric, Franklin, Liberty and Sears/Kenmore). The HTPV pipe used for these vents could be susceptible to corrosion, cracking and joint separation, which could result in the release of carbon monoxide (CO) into living areas, posing a danger to consumers. Goodman did not manufacture the HTPV pipe.

The following table describes the different remedies available to consumers with qualifying furnaces that use the two leading brands of HTPV pipe – Plexvent and Ultravent.

Plexvent owners Ultravent owners Valid claims initiated on or before October 1, 2009, with remediation completed and required documentation submitted by January 1, 2010. Will receive a new, professionally-installed venting system free of chargeor a new, high-efficiency Goodman furnace and suitable vent for the manufacturer's price (of just the furnace), with no charge for labor, associated materials or dealer markup. Valid claims initiated after October 1, 2009 A rebate up to $400 toward either an HTPV replacement system, or a new, high-efficiency furnace from Goodman that does not require HTPV. A rebate up to $250 toward either an HTPV replacement system, or a new, high-efficiency furnace from Goodman that does not require HTPV.

Consumers who register after October 1, 2009 and who choose to repair their systems will be responsible for up-front payment of parts, labor and permits, and will be responsible for arranging to have the work performed.

Consumers should determine whether they have a recalled HTPV pipe system by checking the vent pipes attached to their natural gas furnace. Vent pipes subject to this recall can be identified as follows:

the vent pipes are plastic;

the vent pipes are colored gray or black;

"Plexvent," "Plexvent II" or "Ultravent" is stamped on the vent pipe or printed on stickers placed on pieces used to connect the vent pipes; and

the vent pipes are located on furnaces and the pipes go through the sidewalls of structures.Other plastic vent pipes, such as white PVC, are not included in the recall.

Owners of Goodman furnaces that are vented with HTPV pipe should immediately call Goodman at (800) 394-8084 from 8 a.m. to 4:30 p.m. CT Monday through Friday. CPSC reminds all consumers to have fuel-burning appliances professionally inspected each year to check for cracks or separations in the vents that could allow CO to leak into the home. In addition, CPSC recommends that every home should have at least one CO alarm.
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Owners of previously recalled Goodman Manufacturing Co. plexvent and ultravent high temperature plastic vent (HTPV) pipe systems for furnaces that pose a risk of carbon monoxide leaks who do not respond by Oct. 1, 2009, will be responsible for up-front payment of parts, labor and permits, as well as for arranging to have the work performed. The recall was initially announced in 1998. Details: by Web at http://www.cpsc.gov

Safety Update on TNF Blockers and Risk of Cancer in Children and Young Adults

Safety Update on TNF Blockers and Risk of Cancer in Children and Young Adults

2009-137

Health Canada is informing health care professionals and Canadians that it is working with manufacturers to further strengthen product labelling for the class of drugs known as tumour necrosis factor (TNF) blockers with respect to an increased risk of cancer in children and young adults.

This communication comes in light of similar labelling updates undertaken by the U.S. FDA following their review, which concluded that there is an increased risk of lymphoma and other cancers associated with the use of TNF blocker drugs in children and adolescents. Health Canada has also been reviewing this issue and is currently working with the manufacturers to strengthen existing warnings in the prescribing information for these drugs.

TNF blockers are used to treat patients with chronic inflammatory diseases including juvenile idiopathic arthritis (JIA), rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, Crohn's disease, and ankylosing spondylitis (a type of arthritis). They suppress the activity of tumour necrosis factor, a protein that, when overproduced in the body, can cause inflammation and damage to bones, cartilage and tissue, and lead to immune system-related diseases. There are currently five prescription TNF blockers authorized in Canada : Enbrel (etancercept) , Remicade (infliximab), Humira (adalimumab), Simponi (golimumab), and Cimzia (certolizumab pegol).

Currently the labels for all TNF blockers include warnings and precautions on the risk of lymphomas and other cancers. The labels will be updated to highlight the risk of specific cancers, particularly in the younger patient groups. As well, the label updates will include other new safety information based on reviews conducted by Health Canada , including the risk of new-onset psoriasis in patients treated with TNF blockers. Health Canada will inform health care professionals and Canadians again once these updates are complete.

The role of TNF blockers in the development of cancer is not known. Health Canada has communicated in the past on the risk of the development of certain types of cancers, including lymphoma, associated with the use of these drugs.

Health Canada recommends that patients should not stop taking their TNF blocker without first speaking to their doctor. Patients should contact their health care professional if they have any concerns about any medicines they are taking.

You can report any adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:

Report online at the MedEffect ™ Canada Web site

Call toll-free at 1-866-234-2345

Complete a Canada Vigilance Reporting Form and either: Fax toll-free to 1-866-678-6789

Mail to: Canada Vigilance Program Health CanadaAL 0701C Ottawa , ON K1A 0K9

Media Enquiries:Health Canada(613) 957-2983

Public Enquiries:(613) 957-29911-866-225-0709

FDA Issues Warning Letters to Marketers of Topical Ibuprofen Drug Products

Media Inquiries: Siobhan DeLancey, 301-796-4668, siobhan.delancey@fda.hhs.gov

Consumer Inquiries: 888-INFO-FDA

FDA Issues Warning Letters to Marketers of Topical Ibuprofen Drug Products

The U.S. Food and Drug Administration today announced that the agency issued warning letters to eight companies marketing unlawful over-the-counter (OTC) topical drug products containing the pain reliever ibuprofen.

The products, which contain ibuprofen in combination with a variety of other active ingredients and are marketed for pain relief, are unapproved new drugs that require an approved new drug application in order to be legally marketed. Under its OTC drug monograph system, the FDA allows some OTC drugs to be marketed without first obtaining agency approval. These drugs must comply with applicable monographs, that is, regulations that set requirements for the drugs' labeling, formulations, and indications. Ibuprofen is not included in any OTC drug monograph. Companies wishing to market OTC drugs that do not meet the monograph requirements can submit and receive approval of a new drug application.

“These companies have an obligation to the public to demonstrate to the FDA that their products are safe and effective, and they have failed to do so,” said Deborah M. Autor, director of the Office of Compliance at the FDA's Center for Drug Evaluation and Research.

Orally administered ibuprofen has been approved as a safe and effective treatment for pain and inflammation. There are no approved applications for topical ibuprofen products. Although the FDA has proposed to add orally administered ibuprofen to the applicable OTC monograph, it has never proposed that topical ibuprofen be added to any OTC monograph. Topical ibuprofen is often promoted as a “safer” alternative that can be used in place of oral ibuprofen because of certain side effects, such as stomach ulcers and cardiovascular effects that are associated with prolonged use of oral ibuprofen. However, these safety claims for topical ibuprofen have not been reviewed by the FDA, nor has the agency evaluated what side effects might be associated with such products.

The names of the products and manufacturers that received warning letters are:Emuprofen (Progressive Emu, Inc.)BioEntopic 15% Ibuprofen Crème (BioCentric Laboratories, Inc.)Ibunex Topical Ibuprofen (Core Products International, Inc.)LoPain AF 15% Ibuprofen Crème (Geromatrix Health Products)IB-RELIEF (MEKT LLC)Profen HP (Ridge Medical Products)IbuPRO-10 Plus (Meditrend, Inc. dba Progena Professional Formulations)IBU-RELIEF 12 (Wonder Laboratories)

The FDA warning letters advise the companies that they may not continue to market their products without FDA approval. The FDA is requesting a written response from the companies within 15 business days of receipt of the warning letters stating how they will correct these violations and prevent similar violations in the future.

The warning letters are available on FDA’s Web site at http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2009/default.htm

CPSC to Enforce New CPSIA Requirements for Children’s Products Effective August 14

CPSC to Enforce New CPSIA Requirements for Children’s Products Effective August 14

WASHINGTON, D.C. - On August 14, 2009, new requirements of the Consumer Product Safety Improvement Act (CPSIA) will take effect that are aimed at making children’s products safer and increasing consumer confidence in the marketplace. The U.S. Consumer Product Safety Commission (CPSC) is educating domestic and overseas manufacturers, importers, and distributors of children’s products and other consumer goods of these important new safety requirements.

CPSC Chairman Inez Tenenbaum said the CPSIA’s new requirements will help protect families and she urged businesses to comply. “I will ensure that these requirements are enforced vigorously and fairly,” said Tenenbaum. “By ensuring that toys and other children’s products meet strict lead limits and can be tracked in the event of a recall, I believe children will be better protected in their homes.”

The requirements that become effective on August 14 include:
Lead Content
The limit for lead in children’s products drops from 600 parts per million (ppm) to 300 ppm.

After August 14, it will be unlawful to manufacture, import, sell, or offer for sale, a children’s product that has more than 300 ppm of lead in any part (except electronics) that is accessible to children.
Lead in Paint and Similar Surface Coating Materials

The limit for lead in paint and similar surface-coating materials for consumer use drops from 600 ppm to 90 ppm. The lead paint limits also apply to toys and other articles intended for children as well as certain furniture products. Products subject to these limits cannot be sold, offered for sale, imported or manufactured after August 14 unless they meet the new lower lead limits.

Civil Penalties
Civil penalties increase substantially to a maximum of $100,000 per violation and up to a maximum of $15 million for a related series of violations. Previously, civil penalties were a maximum of $8,000 per violation and up to a maximum of $1.825 million for a related series of violations.

Tracking Labels
Manufacturers must place permanent distinguishing marks (tracking label) on any consumer product primarily intended for children 12 and younger made on or after August 14, 2009. The permanent marks must enable consumers to ascertain basic information, including the manufacturer or private labeler, location, the date of manufacture, and more detailed information on the manufacturing process such as a batch or run number. The permanent distinguishing marks must appear on the product itself and its packaging to the extent practicable. Learn more about the tracking label requirement at www.cpsc.gov/about/cpsia/sect103.html#faqs

Catalog Advertising
Advertising for certain toys and games intended for use by children from three to six years old must have warnings regarding potential choking hazards to children younger than three. The requirement to include warnings in Internet advertisements went into effect on December 12, 2008. There was a grace period for the requirement for catalogues and other printed materials, but this grace period expired August 9, 2009. All catalogues and other printed materials distributed on or after August 9, 2009, regardless of when they were printed, must include the appropriate warnings.

Visit CPSC’s Web site at www.cpsc.gov/about/cpsia/cpsia.html for more information about the agency’s successful implementation of the CPSIA.

U.S. FDA devices chief steps down

U.S. FDA devices chief steps down

The head of the U.S. Food and Drug Administration's device center stepped down on Tuesday, a move that follows a raft of scandals over safety recalls, concerns over the agency's device approval process and other controversial issues.

Daniel Schultz, who served at the agency's Center for Devices and Radiological Health for 15 years, resigned after reaching an agreement with FDA Commissioner Margaret Hamburg "that my stepping down at this time would be in the best interest of the center and the agency.

"His departure follows a string of problems at the center, such as recalls of various products including those made by top device makers Medtronic Inc and Boston Scientific Corp thought to have met certain standards.

Agency scientists have also complained about pressure from top managers at the device center.

In a separate letter to FDA staff, Hamburg said she had appointed Jeff Shuren, the agency's current associate commissioner for policy and planning, to lead the device center on an acting basis.

CPSC Launches Resale Round-up Campaign to Keep Dangerous Recalled Products Out of Resale Stores and Off the Internet

CPSC Launches Resale Round-up Campaign to Keep Dangerous Recalled Products Out of Resale Stores and Off the Internet

The U.S. Consumer Product Safety Commission (CPSC) today announced its Top Ten list of recalled children’s products as part of the agency’s “Resale Round-up” campaign. CPSC’s goal is to protect consumers by getting dangerous recalled products out of resale stores and off the Internet. Re-selling recalled products is a violation of federal law.

“Those who re-sell recalled children’s products are not only breaking the law, they are putting children’s lives at risk,” said CPSC Chairman Inez Tenenbaum. “Resale stores should make safety their business and check for recalled products and hazards to children.”

A CPSC study conducted in 1999 found that nearly 70 percent of resale stores sold at least one recalled or otherwise hazardous product.

CPSC is partnering with the National Association of Resale & Thrift Shops (NARTS), the Salvation Army, state agencies, and others to alert re-sellers about recalled products, product hazards including cribs that do not meet current safety standards, drawstrings in children’s clothing, and the Consumer Product Safety Improvement Act (CPSIA).

“NARTS fully supports CPSC’s outreach efforts to resale stores,” said Adele Meyer, NARTS’ Executive Director. “Our members are resale professionals committed to product safety who believe good value and selling safe products go hand in hand.”

The agency’s education campaign, which will include safety seminars for resale store owners and employees, is part of CPSC’s commitment to protecting consumers, especially children.

CPSC’s Internet surveillance team is monitoring online retailers and auction sites for sales of recalled and hazardous products. Re-sellers are reminded that they must comply with the federal law which will be enforced for in-store and online sales.

CPSC has released a new “Handbook for Resale Stores and Product Re-sellers” to help resellers comply with the law. It can be found at www.cpsc.gov/cpscpub/pubs/thrift/thrguid.pdf or can be ordered by calling CPSC’s Hotline at (800) 638-2772.

CPSC’s Top Ten list of recalled children’s products includes:

March 10, 1993 Playskool Travel-Lite Play Yards If the side rails of the portable crib fold during use, an infant can become entrapped and suffocate. Three deaths have been reported.

June 25, 1997 Evenflo Happy Camper Play Yards The product can collapse, trapping the child in the "V" formed by the folded top rails. The rotating plastic hinges can crack or break, presenting a sharp edge or possibly allowing the child to escape. Evenflo and CPSC are aware of three deaths involving the play yards.

December 19, 1994 & February 28, 2001 Baby Trend Home and Roam and Baby Express Portable Cribs and Play Yards These cribs/play yards can collapse and entrap an infant. In

January 2001, a 9-month-old baby in Longview, Wash., died of asphyxiation when her neck was caught in the V-shape created by the collapsed sides of her crib/play yard. There have been three other deaths and three reports of babies found not breathing (who were revived) associated with these products.

March 31, 2006 & April 19, 2007 Magnetix Magnetic Building Sets Tiny magnets inside the plastic building pieces and rods can fall out. Magnets found by young children can be swallowed or aspirated. If more than one magnet is swallowed, the magnets can attract to each other and cause intestinal perforation or blockage, which can be fatal. This product is unsuitable for young children. CPSC is aware of one death and at least 27 serious injuries.

July 19, 2007 Easy Bake Ovens Young children can insert their hands into the oven's front opening, and get their hands or fingers caught, posing entrapment and burn hazards.

August 14, 2007 & November 21, 2006 Polly Pocket Dolls with Magnets Small magnets inside the dolls and accessories can come loose. The magnets can be found by young children and swallowed or aspirated. If more than one magnet is swallowed, the magnets can attract to each other and cause intestinal perforation or blockage, which can be fatal. CPSC is aware of 3 serious injuries.

July 2, 2009, September 17, 2008 & September 21, 2007 Simplicity Drop Side Cribs The drop side can detach. When the drop side detaches, it creates space between the drop side and the crib mattress. Infants and toddlers can roll into this space and become entrapped which can lead to suffocation. CPSC is aware of 10 deaths associated with Simplicity drop side cribs.

September 11, 2008, August 27, 2008 & August 28, 2008 Simplicity Bassinets (also includes bassinets with Graco or Winnie the Pooh motif) The Simplicity 3-in-1 and 4-in-1 convertible bassinets contain metal bars that are covered by an adjustable fabric flap which is attached by velcro. The fabric is folded down when the bassinet is converted into a bed-side co-sleeping position. If the velcro is not properly re-secured when the flap is adjusted, an infant can slip through the opening and become entrapped between the metal bars and suffocate. CPSC is aware of at least three deaths involving Simplicity bassinets.

February 12, 2009 Hill Sportswear hooded drawstring sweatshirts CPSC received one report of a death involving a 3-year-old boy in Fresno, Calif. He was strangled when the drawstring on the hooded sweatshirt that he was wearing became stuck on a playground set.

April 2, 2009 Evenflo Envision High Chairs Recline fasteners and metal screws on both sides of the high chair can loosen and fall out, allowing the seatback to detach or recline unexpectedly. Children can fall backwards or fall out of the high chair and suffer bumps and bruises to the head, abrasions, cuts and bruises. Detached hardware also poses a choking hazard to children.

Ross Stores Agrees To Pay $500,000 Civil Penalty For Failing To Report Drawstrings In Children’s Outerwear

Ross Stores Agrees To Pay $500,000 Civil Penalty For Failing To Report Drawstrings In Children’s Outerwear

The U.S. Consumer Product Safety Commission (CPSC) announced today that Ross Stores Inc., of Pleasanton, Calif. has agreed to pay a civil penalty of $500,000. The penalty settlement, which has been provisionally accepted by the Commission, resolves CPSC staff allegations that Ross knowingly failed to report to CPSC immediately, as required by federal law, that children’s hooded sweatshirts it sold had drawstrings at the neck.

Children’s upper outerwear with drawstrings, including sweatshirts, pose a strangulation hazard to children which can result in serious injury or death. CPSC and the sweatshirts’ importers announced recalls (07-777, 08-121, 08-146, 08-192) of the products.

In February 1996, CPSC issued drawstring guidelines (pdf) to help prevent children from strangling or getting entangled in the neck and waist drawstrings in upper outerwear, such as jackets and sweatshirts. In May 2006, CPSC’s Office of Compliance announced (pdf) that children’s upper outerwear with drawstrings at the hood or neck would be regarded as defective and as creating a substantial risk of injury to young children.

Federal law requires manufacturers, distributors, and retailers to report to CPSC immediately (within 24 hours) after obtaining information reasonably supporting the conclusion that a product contains a defect which could create a substantial product hazard, creates an unreasonable risk of serious injury or death, or fails to comply with any consumer product safety rule or any other rule, regulation, standard, or ban enforced by CPSC.

In agreeing to the settlement, Ross Stores denies CPSC's allegations that it knowingly violated the law.

FDA Takes Action Against Teva Animal Health Inc.

Media Inquiries: Michael Herndon, 301-796-4673, michael.herndon@fda.hhs.gov

Consumer Inquiries: 888-INFO-FDA

FDA Takes Action Against Teva Animal Health Inc.

Company fails to adhere to current Good Manufacturing Practice regulations

The U.S. Food and Drug Administration announced a consent decree of permanent injunction filed today, that prohibits Teva Animal Health Inc., its president, and two principals from its parent company, from manufacturing and distributing adulterated veterinary drugs. The injunction, once entered by the court, will prevent the defendants from manufacturing and distributing veterinary drugs until they achieve compliance with current Good Manufacturing Practice (cGMP) and obtain FDA approval.

“Good manufacturing practice standards are the backbone of product quality and the instrument on which the FDA relies most heavily for assurance that veterinary drug products are safe and effective,” said Bernadette Dunham, D.V.M., Ph.D., director of the FDA’s Center for Veterinary Medicine.

During inspections between 2007 and 2009, the FDA found significant cGMP violations at Teva Animal Health's facilities, located in St. Joseph, Mo.

Under the terms of the consent decree, Teva Animal Health cannot resume manufacturing and distributing veterinary drugs until adequate methods, facilities, and controls are established and an independent expert inspects the facilities and procedures and certifies that they comply with cGMP. The FDA also will also inspect Teva Animal Health's facilities as needed before authorizing the company to resume operations. If, after resuming operations, the defendants fail to comply with any provision of the consent decree, cGMP, or the Federal Food, Drug, and Cosmetic Act, the FDA may order the company to stop manufacturing and distributing veterinary drugs, recall the products, or take other corrective actions.

“The FDA will not tolerate the manufacture and distribution of adulterated animal drugs,” said Michael Chappell, the FDA’s acting associate commissioner for regulatory affairs. “Veterinarians and pet owners can be assured that the FDA will investigate and take regulatory actions against companies that produce animal drugs under conditions and controls that are inadequate to assure their safety and quality.”

In the event of future violations, the consent decree also subjects Teva Animal Health to payments of $20,000 for each day the defendants fail to comply with any provision of the decree and an additional $25,000 for each shipment of veterinary drugs in violation of the decree, up to
$7.5 million per year.