WormGuy

http://www.cpsc.gov/cpscpub/prerel/prhtml13/13008.html

FOR IMMEDIATE RELEASE

October 16, 2012

Release #13-008

Firm's Recall Hotline: (800) 919-1917

CPSC Recall Hotline: (800) 638-2772

CPSC Media Contact: (301) 504-7908

Children's Apparel Network Recalls Fleece Hoodie and T-Shirt Sets Due to Violation of Lead Paint Standard; Sold Exclusively at Target

WASHINGTON, D.C. - 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. It is illegal to resell or attempt to resell a recalled consumer product.

Name of Product: Fleece Hoodie and T-Shirt Sets

Units: About 6,200

Manufacturer: Children's Apparel Network, Ltd. of New York, N.Y.

Hazard: The surface coating on the zipper of the fleece hoodie and t-shirt sets contain excessive levels of lead, violating the federal lead paint standard.

Incidents/Injuries: None reported

Description: The recalled product is a two-piece coordinated set with fleece hoodie and t-shirt. They were sold in red/white, gray/red, and black/blue color combinations and in assorted sizes from 12M to 5T. The hoodies have Disney character designs in three different styles. "RN 16435" and the following identification number, corresponding to the style, are printed on the label along the hoodie's side seam:

Style Description

Identification Number

Red Fleece Hoodie with Snow White

DP4253B

Grey Fleece Hoodie with Mickey Mouse

J4821

Blue Fleece Hoodie with Cars

J4820-A

Sold exclusively at: Target stores nationwide and Target.com from October 2011 through December 2011 for approximately $18.

Manufactured in: Pakistan

Remedy: Consumers should take the product away from the child immediately and return the set to any Target store for a full refund.

Consumer Contact: For additional information, contact Children's Apparel Network at (800) 919-1917 between 9 a.m. and 4 p.m. CT Monday through Friday, or visit the firm's website at www.childrensapparelnetwork.com and click on the "Press" link.

John

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm324369.htm?source=govdelivery

FDA NEWS RELEASE

For Immediate Release: Oct. 18, 2012

Media Inquiries: Stephanie Yao, 301-796-0394, stephanie.yao@fda.hhs.gov

Consumer Inquiries: 888-INFO-FDA

FDA approves Jetrea for symptomatic vitreomacular adhesion in the eyes

On Oct. 17, the U.S. Food and Drug Administration approved Jetrea (ocriplasmin), the first drug approved to treat an eye condition called symptomatic vitreomacular adhesion (VMA).

VMA can contribute to eye problems if the vitreous (jelly in the center of the eye) starts to move away from the macula (a part of the retina responsible for reading vision). This movement can lead to damage of the macula due to pulling or tugging on the macula.

Jetrea is an enzyme that breaks down proteins in the eye responsible for VMA. The breakdown of these proteins allows a better separation between the vitreous and macula and can reduce the chances that tugging will occur. The alternative treatment for this condition is a surgical procedure called a vitrectomy.

“Today’s approval represents a significant advancement in treatment for patients with symptomatic VMA,” said Edward Cox, M.D., M.P.H., director of the Office of Antimicrobial Products in FDA’s Center for Drug Evaluation and Research. “Those with this sight-threatening disease now have a non-surgical treatment option.”

The safety and effectiveness of Jetrea were established in two clinical studies involving 652 patients with symptomatic VMA. Patients were randomly assigned to receive a single injection of Jetrea into the eye or a substance without the active ingredient.

Patients were evaluated over the next 28 days and for any side effects over the next six months. The studies found that VMA resolved in 26 percent of patients treated with Jetrea compared with 10 percent of those treated with the inactive product.

The most common side effects reported in patients treated with Jetrea include eye floaters; bleeding of the conjunctiva, the tissue that lines the inside of the eyelids and covers the white part of the eye; eye pain; flashes of light (photopsia); blurred vision; unclear vision; vision loss; retinal edema (swelling); and macular edema.

Jetrea is manufactured by Iselin, N.J.-based ThromboGenics Inc.

For more information:

FDA Approved Drugs: Questions and Answers

1

FDA: Drug Innovation

2

John

For me another gathering is over. I just got back home safely and trying to digest everything that I experienced. I'll post pics as soon as I can.

John

Let me sit the record straight on this "chili reciepe", I brought all of the goodies to make MY chili and then I was informed that "SHE" was going to make it "HER" way. So if it don't turn out right then I am innocent!

Lovinit and Hubby got here and Mt.Rider came sliding in about 4:30. Everyone is settling in and getting ready to go feed the animals before dinner. GunPlumer, Darlenes son, and me cut, split, hauled, and stacked lots of wood today. Something bit me on my arm during the night so I am not happy about the pain but hey, I will survive...

More breaking news when it happens

John

Hey guys, I,m using MomM,s tablet for this since Darlene,s computer kicked me out I will have lots of pictures to share but not until I get back home Sunday. Gotta go feed the puppies and help put down more gravel.

John

I'll throw in 5 boxes of 7.62x49, a box of 22lr, and a few loose rounds of .45 acp. It's not much but it will help out.

John

I wonder if they can stop a person from taking donations for items? Instead of a selling items take donations for them.

John

Three more days!

John

http://www.cpsc.gov/cpscpub/prerel/prhtml13/13003.html

FOR IMMEDIATE RELEASE

October 3, 2012

Release #13-003

Firm's Recall Hotline: (888) 641-9739

CPSC Recall Hotline: (800) 638-2772

CPSC Media Contact: (301) 504-7908

GE Media Contact: (888) 240-2749

GE Recalls Front Load Washers Due to Injury Hazard

WASHINGTON, D.C. - 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. It is illegal to resell or attempt to resell a recalled consumer product.

Name of Product: GE Profile™ Front Load Washers

Units: About 62,000

Importer: GE Appliances, of Louisville, Ky.

Hazard: The washer’s basket can separate during use and break the washer’s top panel, posing an injury hazard to consumers.

Incidents/Injuries: GE has received 19 reports of washer baskets separating, including 10 reports of top panel breakage. No injuries have been reported.

Description: This recall involves GE Profile™ frontload washing machines with model numbers beginning with WPDH8800, WPDH8900 and WPDH8910. All serial numbers with these models are included in this recall. The washers were sold in gold, red and white colors. The model number is located on the washer’s right side near the bottom and behind the door near the door frame visible when the door is opened.

Brand

Model Number Begins With:

And Serial Number Begins With:

GE Profile™

WPDH8800

All serial numbers with these models are included.

GE Profile™

WPDH8900

All serial numbers with these models are included.

GE Profile™

WPDH8910

All serial numbers with these models are included.

Sold at: Best Buy, Lowe’s, Sears, The Home Depot and other department and retail stores nationwide, from July 2008 to August 2011 for between $1,199 and $1,599.

Manufactured in: China

Remedy: Consumers should immediately stop using the recalled washers and contact GE for a free repair.

Consumer Contact: For additional information, contact GE Appliances at (888) 641-9739 between 8 a.m. and 5 p.m. ET Monday through Friday or visit the firm’s website at www.geappliances.com/products/recall

John

http://www.cpsc.gov/cpscpub/prerel/prhtml13/13004.html

FOR IMMEDIATE RELEASE

October 4, 2012

Release #13-004

Firm's Recall Hotline: (877) 328-9222

CPSC Recall Hotline: (800) 638-2772

CPSC Media Contact: (301) 504-7908

Pink Angel Embroidered Girls' Denim Shorts Recalled by Buy Buy Baby Due to Choking Hazard

WASHINGTON, D.C. - 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. It is illegal to resell or attempt to resell a recalled consumer product.

Name of Product: Pink Angel Embroidered Girls’ Denim Shorts

Units: About 1,170

Importer: Franshaw, Inc., of New York, N.Y.

Hazard: Decorative studs on the denim shorts’ pockets can detach and pose a choking hazard to young children.

Incidents/Injuries: Buy Buy Baby received one report of the decorative studs detaching from the shorts. No injuries have been reported.

Description: This recall involves “Pink Angel” branded embroidered denim shorts for girl infants and toddlers in sizes 12M to 4T. The shorts come with a bright pink lace belt and feature two embroidered butterflies on the left front panel with decorative studs attached to the front and rear pockets. Style numbers B91540 or B11540 can be found on the hangtag of the shorts.

Sold at: Buy Buy Baby retail locations from January 2012 to July 2012 for about $10 to $12.

Manufactured in: China

Remedy: Refund.

Consumer Contact: Buy Buy Baby toll-free at (877) 328-9222 any time, or visit the firm’s website www.buybuybaby.com and go to the link Safety and Recalls at the bottom of the homepage for more information.

John

http://www.cpsc.gov/cpscpub/prerel/prhtml13/13002.html

FOR IMMEDIATE RELEASE

October 2, 2012

Release #13-002

Firm's Recall Hotline: (877) 813-8516

CPSC Recall Hotline: (800) 638-2772

CPSC Media Contact: (301) 504-7908

Haier America Recalls 42-inch LED-TVs Due to Risk of Injury

WASHINGTON, D.C. - 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. It is illegal to resell or attempt to resell a recalled consumer product.

Name of Product: Haier® 42-inch LED TVs

Units: About 5,000

Importer: Haier America Trading L.L.C., of New York, N.Y.

Hazard: The TV stand's neck support can break and cause the TV to tip over, posing a risk of injury to the consumer.

Incidents/Injuries: Haier America and CPSC have received 184 reports of the TV stand's neck cracking or breaking. No injuries have been reported.

Description: This recall involves Haier 42-inch LED TVs with model number LE42B1380. "Haier" is printed on the front of the TV and the model number is printed on a label on the back of the unit.

Sold at: Fry's Electronics and other retail stores nationwide and online at Amazon.com and other online retailers from September 2011 through March 2012 for about $450.

Manufactured in: China

Remedy: Consumers should immediately stop using and detach the TV from the stand and keep both the TV and the base in a safe location. Consumers should contact Haier America to request a free replacement stand neck to be used with the original base. Consumers with a wall-mounted TV may continue to use it but should request a free replacement stand neck in case the TV is used with the stand in the future.

Consumer Contact: For more information, contact Haier America toll-free at (877) 813-8516 between 7 a.m. and 10 p.m. ET Monday through Friday, between 8 a.m. and 9 p.m. ET Saturday and between 8 a.m. and 8 p.m. ET Sundays. Consumers can visit the firm's website at www.haieramerica.com and click on Product Recalls.

John

http://www.cpsc.gov/cpscpub/prerel/prhtml13/13001.html

FOR IMMEDIATE RELEASE

October 2, 2012

Release #13-001

Firm's Recall Hotline: (888) 221-7417

CPSC Recall Hotline: (800) 638-2772

CPSC Media Contact: (301) 504-7908

Fitness Anywhere Recalls Early Model Suspension Trainer Devices Due to Fall Hazard

WASHINGTON, D.C. - 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. It is illegal to resell or attempt to resell a recalled consumer product.

Name of Product: Suspension Trainer Devices

Units: About 40,000

Importer: Fitness Anywhere LLC, of San Francisco, Calif.

Hazard: The strap length-adjustment buckles can break, posing a fall hazard.

Incidents/Injuries: Fitness Anywhere has received 570 reports of the strap length-adjustment buckles breaking with 82 reports of the user falling, including 13 reports of head, face, shoulder and hip injuries.

Description: This recall involves older model "Professional" (P1) and "Tactical" (T1) TRX Suspension Trainer devices manufactured between January 2006 and July 2007. The recalled products' anchor straps are yellow or khaki nylon with a carabiner at the top end and a black nylon loop on the bottom end. A black and yellow or black and khaki nylon strap is threaded through the black nylon loop on the anchor strap to form a "Y." On each side of the "Y," the strap has a cam buckle, which is used to adjust the length of the straps. Each end of the "Y" strap has a foam-covered hand grip and a foot cradle. The recalled devices have hand grips with no end bumpers, which are black plastic caps covering the ends and preventing the plastic under the foam from being exposed. They do not have an extra nylon loop, called a locking loop, attached at the point where the anchor strap and the "Y" straps are joined and designed to limit the slippage of the straps. The recalled products also have badges on the straps with the TRX logo and the word "Professional" (for P1 devices) or "Tactical" (for T1 devices) on them. The words and logo are surrounded by raised dots or have double lines through them.

Sold at: Health and fitness stores and studios nationwide and online at www.FitnessAnywhere.com from January 2006 through December 2009 for about $150 to $200.

Manufactured in: China

Remedy: Consumers should immediately stop using the recalled product and contact Fitness Anywhere to arrange to return the recalled product for a replacement TRX Suspension Trainer device. Return authorization is required prior to returning the units.

Consumer Contact: For additional information, contact Fitness Anywhere toll-free at (888)-221-7417 between 9 a.m. and 5 p.m. PT or CustomerCare@trxtraining.com, or visit the company's website at www.trxtraining.com

John

http://thechart.blogs.cnn.com/2012/10/02/popcorn-recalled-due-to-possible-listeria-contamination/?hpt=hp_t3

*Snip*

Popcorn recalled due to possible Listeria contamination

Dale and Thomas Popcorn is voluntarily recalling bags of its flavored, ready-to-eat Indiana-brand products due to a possible Listeria monocytogenes contamination, according to the Food and Drug Administration.

The recalled popcorn bags were distributed after August 8 and have "best by" dates of February 4, 2013 to March 12, 2013, according to the FDA. Consumers can check specific UPC codes from this list.

John

I have some in mylar bags and in jars. I think mine are about 4 years old and still good.

John

http://money.cnn.com/2012/10/01/autos/honda-accord-recall/index.html?hpt=hp_t3

*Snip*

NEW YORK (CNNMoney) -- Honda is recalling more than 500,000 of its popular Accord vehicles because of a potential fire risk in their engines.

Honda said roughly 572,000 Accord V6's from model years 2003-2007 are covered under the recall. The power steering hoses in these cars are at risk of leaking, creating smoke and potentially sparking engine fires, according to the National Highway Traffic Safety Administration.

John

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm321271.htm?source=govdelivery

FDA NEWS RELEASE

For Immediate Release: Sept. 27, 2012

Media Inquiries: Stephanie Yao, 301-796-0394, stephanie.yao@fda.hhs.gov

Consumer Inquiries: 888-INFO-FDA

FDA approves new treatment for advanced colorectal cancer

Priority review completed one month ahead of goal date

The U.S. Food and Drug Administration today approved Stivarga (regorafenib) to treat patients with colorectal cancer that has progressed after treatment and spread to other parts of the body (metastatic).

Stivarga is a multi-kinase inhibitor that blocks several enzymes that promote cancer growth. The drug was reviewed under the FDA’s priority review program that provides an expedited six-month review for drugs that offer major advances in treatment or that provide treatment when no adequate therapy exists.

Stivarga is being approved one month ahead of the product’s prescription drug user fee goal date of Oct. 27, 2012, the date the agency was scheduled to complete review of the drug application.

“Stivarga is the latest colorectal cancer treatment to demonstrate an ability to extend patients’ lives and is the second drug approved for patients with colorectal cancer in the past two months,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in FDA’s Center for Drug Evaluation and Research.

According to the Centers for Disease Control and Prevention, colorectal cancer is the third most common cancer in men and in women and the third leading cause of cancer death in men and in women in the United States. The National Institutes of Health estimates 143,460 Americans will be diagnosed with colorectal cancer, and 51,690 will die from the disease in 2012.

The safety and effectiveness of Stivarga were evaluated in a single clinical study of 760 patients with previously treated metastatic colorectal cancer. Patients were randomly assigned to receive Stivarga or placebo in addition to best supportive care (BSC), which includes treatments to help manage side effects and symptoms of cancer. Patients received treatment until their cancers progressed or side effects became unacceptable.

Study results showed patients treated with Stivarga plus BSC lived a median of 6.4 months compared to a median of five months in patients treated with placebo plus BSC. Results also showed patients treated with Stivarga plus BSC experienced a delay in tumor growth (progression-free survival) for a median of two months compared to a median of 1.7 months in patients receiving placebo plus BSC.

Stivarga is being approved with a Boxed Warning alerting patients and health care professionals that severe and fatal liver toxicity occurred in patients treated with Stivarga during clinical studies. The most common side effects reported in patients treated with Stivarga include weakness or fatigue, loss of appetite, hand-foot syndrome (also called palmar-plantar erythrodysesthesia), diarrhea, mouth sores (mucositis), weight loss, infection, high blood pressure, and changes in voice volume or quality (dysphonia).

In August 2012, the FDA approved Zaltrap (ziv-aflibercept) for use in combination with a FOLFIRI (folinic acid, fluorouracil and irinotecan) chemotherapy regimen to treat adults with metastatic colorectal cancer.

Stivarga is marketed by Bayer HealthCare Pharmaceuticals, based in Wayne, N.J. Zaltrap is marketed by Bridgewater, N.J.-based sanofi-aventis.

For more information:

FDA: Office of Hematology and Oncology Products¹

FDA: Approved Drugs: Questions and Answers²

FDA: Drug Innovation³

CDC: Colorectal (Colon) Cancer⁴

NIH: Colon and Rectal Cancer⁵

John

http://www.cpsc.gov/cpscpub/prerel/prhtml12/12286.html

FOR IMMEDIATE RELEASE

September 27, 2012

Release #12-286

Firm's Recall Hotline: (888) 270-8595

CPSC Recall Hotline: (800) 638-2772

CPSC Media Contact: (301) 504-7908

HC Media Contact: (613) 957-2983

Atomic Aquatics Recalls Cobalt Dive Computer Due to Impact and Drowning Hazard

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 consumer product. 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: Cobalt Dive Computer

Units: About 4,000 in the United States and 200 in Canada

Manufacturer: Atomic Aquatics, of Huntington Beach, Calif.

Hazard: The unit can leak and cause the lens of the computer to blow off suddenly, which could result in impact injuries, and can cause a gas leak, posing a drowning hazard.

Incidents/Injuries: The firm has received 23 reports of leaks caused by the lens being forcefully expelled from the computer due to excess air pressure inside the computer. No injuries were reported.

Description: This recall involves Atomic Aquatics brand Cobalt dive computers. These handheld, console-style dive computers have LCD screens and four magnetic control buttons located below the screen. A fitting at the bottom of the computer connects to the high pressure hose of a scuba diving regulator. The name Atomic Aquatics logo is imprinted on the front of the console, below the screen. The recalled products can be identified by the manufacture dates, which are determined by the first four numbers of the serial number with the first 2 digits signifying the week of manufacture (01 through 52) and the second 2 digits signifying the year of manufacture (10, 11 or 12). The dates of manufacture are between May 31, 2010 and April 16, 2012. Serial numbers, 2210-XXXX through 1612-XXXX, can be found by scrolling to the "System Info" screen on the computer.

The recall affects all Cobalt computers with serial numbers that start with any of the following numbers:

10 Series:

2210, 2910, 4010, 4710, 5010

11 Series: 1111, 1711, 2611, 2811, 3211, 3311, 3411, 3511, 3611, 3711, 3811, 3911, 4011, 4111, 4211, 4511, 4611, 5211

12 Series:

0812, 1112, 1212, 1312, 1412, 1612

Sold at: Authorized Atomic Aquatics dealers sold Cobalt dive computers from November 2010 through July 2012 for about $1200.

Manufactured in: United States

Remedy: Consumers should immediately stop using the recalled dive computers and return the unit to either an authorized Atomic Aquatics dealer or the Atomic Aquatics factory for inspection and repair.

Consumer Contact: For additional information, contact Atomic Aquatics toll-free at (888) 270-8595 between 8 a.m. and 5 p.m. PT Monday through Friday or on firm's website at www.atomicaquatics.com. Consumers can also email the firm at sales@atomicaquatics.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=1685

John

http://www.cpsc.gov/cpscpub/prerel/prhtml12/12285.html

FOR IMMEDIATE RELEASE

September 27, 2012

Release #12-285

Firm's Recall Hotline: (800) 654-3696

CPSC Recall Hotline: (800) 638-2772

CPSC Media Contact: (301) 504-7908

Captain Cutlass Pirate Toy Guns Recalled by Dillon Importing Due to Violation of Lead Paint Standard

WASHINGTON, D.C. - 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. It is illegal to resell or attempt to resell a recalled consumer product.

Name of Product: Captain Cutlass Toy Pirate Pistols

Units: About 6,970

Importer: Dillon Importing Co., of Oklahoma City, Okla.

Manufacturer: Ko Lik Manufacturing Ltd., of Hong Kong, China

Hazard: The surface paints on the pirate toy pistols contain excessive levels of lead, a violation of the federal lead paint standard.

Incidents/Injuries: None reported.

Description: This recall involves Captain Cutlass Pirate Pistol toys with a brown plastic grip, a black metallic stock and barrel, and a muzzle with an orange cap. The double-barreled toy pistol has one trigger and two hammers. A skull and crossbones motif is engraved on the grip.

Sold at: Halloween and specialty stores nationwide from April 2008 through May 2012 for about $6.50.

Manufactured in: China

Remedy: Consumers should immediately take the recalled pistol toys away from children and contact Dillon Importing for instructions on returning the product for a full refund.

Consumer Contact: For additional information, contact toll-free at (800) 654-3696 between 9 a.m. and 5 p.m. CT Monday through Friday, or visit the firm's website at www.dillonimporting.com

John

http://www.cpsc.gov/cpscpub/prerel/prhtml12/12283.html

FOR IMMEDIATE RELEASE

September 27, 2012

Release #12-283

Firm's Recall Hotline: (877) 755-3336

CPSC Recall Hotline: (800) 638-2772

CPSC Media Contact: (301) 504-7908

Cabot Recalls Wood Cleaner and Wood Brightener With Spray Pump Due To Irritation and Burn Hazard

WASHINGTON, D.C. - 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. It is illegal to resell or attempt to resell a recalled consumer product.

Name of Product: Wood Cleaner and Wood Brightener in container with spray pump.

Units: About 17,500 units of the Wood Cleaner and 10,900 units of the Wood Brightener.

Manufacturer: Cabot Stains, a division of Valspar Corp., of Newburyport, Mass.

Hazard: The spray pump used for both products can lose its seal, causing the product to leak. Chemicals in these products can cause burning or other serious injuries if the product comes into contact with skin or eyes or is ingested.

Incidents/Injuries: Three incidents of leaks have been reported. No injuries have been reported.

Description: Both products come in 1.3 gallon white handle tanks with black pump assembly and sprayer hose. The front has a yellow Cabot label with the product name. The back panel label contains instructions for use and product information and UPC codes 080351810503 on the Wood Cleaner bottles and 080351810497 on the Wood Brightener bottles.

Sold at: Ace Hardware, Do It Best, Farm & Fleet, Lowes Home Improvement Stores, United Hardware, and other hardware stores nationwide from March 2011 until June 2012 for about $25.

Manufactured in: United States

Remedy: Consumers should immediately discontinue use of the products and return them to the store of purchase for a full refund. Consumers should also not attempt to reuse empty containers.

Consumer Contact: For additional information, contact Cabot toll-free at (877) 755-3336 between 8:00 a.m. and 8:00 p.m. 7 days a week, or log on to www.cabotstain.com/recall

John

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm321650.htm?source=govdelivery

FDA NEWS RELEASE

For Immediate Release: Sept. 28, 2012

Media Inquiries: Stephanie Yao, 301-796-0394, stephanie.yao@fda.hhs.gov

Consumer Inquiries: 888-INFO-FDA

FDA approves Humira to treat ulcerative colitis

The U.S. Food and Drug Administration today expanded the approved use of Humira (adalimumab) to include treatment of moderate-to-severe ulcerative colitis in adults.

Humira is approved to control ulcerative colitis when immunosuppressant medicines like corticosteroids, azathioprine, and 6-mercaptopurine have not worked. The drug is an anti-tumor necrosis factor (TNF) that blocks proteins that play an important role in abnormal inflammatory and immune responses.

Ulcerative colitis is a chronic disease that causes inflammation and ulcers in the inner lining of the large intestine. It is one of two main forms of chronic inflammatory bowel disease and affects about 620,000 Americans, according to the National Institutes of Health.

“Each patient with ulcerative colitis experiences the disease differently, and treatment must be adjusted to meet each individual’s needs,” said Donna Griebel, M.D., director of the Division of Gastroenterology and Inborn Errors Products in FDA’s Center for Drug Evaluation and Research. “Today’s approval provides an important new treatment option for patients who have had an inadequate response to conventional therapy.”

The FDA previously approved Humira to treat rheumatoid arthritis (2002), psoriatic arthritis (2005), ankylosing spondylitis (2006), Crohn’s disease (2007), plaque psoriasis (2008) and juvenile idiopathic arthritis (2008).

Patients with ulcerative colitis are normally evaluated for stool frequency, rectal bleeding, endoscopic findings and a physician’s assessment, which combined provide a score ranging from 0 to 12 to help assess the activity of ulcerative colitis. This scoring system is commonly referred to as the Mayo score.

Humira’s safety and effectiveness for ulcerative colitis were established in two clinical studies. A total of 908 patients who had never been treated with a TNF-blocker, or who lost response to or were intolerant to TNF-blockers participated in the studies. All patients enrolled in the studies had a Mayo score of 6 to 12 and an endoscopy subscore of 2 to 3. Patients were randomly assigned to take Humira or a placebo.

The studies were designed to measure the percentage of patients whose Mayo score decreased to 2 or less with no individual subscore of more than 1 after eight weeks of treatment. Patients who obtained such reductions in the Mayo score were determined to have achieved clinical remission.

Results from both studies showed 16.5 percent to 18.5 percent of patients treated with Humira achieved clinical remission compared with 9.2 percent to 9.3 percent of patients receiving placebo. Additionally, in the second study, 8.5 percent of patients treated with Humira sustained clinical remission compared with 4.1 percent of patients treated with placebo. The effectiveness of Humira has not been established in patients with ulcerative colitis who have lost response to or were intolerant to TNF blockers.

The FDA-approved dosing regimen for Humira for ulcerative colitis begins with an initial dose of 160 milligrams, a second dose two weeks later of 80 mg, and a maintenance dose of 40 mg every other week, thereafter. The drug should only continue to be used in patients who have shown evidence of clinical remission by eight weeks of therapy.

No new side effects were identified during clinical studies. Common side effects of Humira include infections, reactions at the injection site, headache, and rash.

Humira is manufactured by Abbott Laboratories, based in North Chicago, Ill.

For more information:

FDA Approved Drugs: Questions and Answers¹

NIH: Ulcerative Colitis²

John

http://money.cnn.com/2012/09/29/autos/gm-recall/index.html?hpt=hp_t3

:Snip:

NEW YORK (CNNMoney) -- General Motors is recalling more than 40,000 vehicles, citing concerns that a fuel pump module could crack and cause a fire in the event of a fuel leak.

The recall, disclosed in a letter by GM (GM, Fortune 500) to the National Highway Traffic Safety Administration (NHTSA) Friday, affects five models from 2007 through 2009: the Chevrolet Cobalt (2007-2009), Chevrolet Equinox (2007), Pontiac G5 (2007-2009), Pontiac Torrent (2007) and Saturn Ion (2007).

John

Oh trust me when I say it will not be as easy as it was last time. It is time to ramp up our security! I would suggest that everyone might want to make sure that they are up to date on their canning terminology, demonstrating proficiency in field stripping their personal carry weapon, the life expectancy of properly stored food items, and be able to identify herbs by picture. A failure on any of these or others that WILL be done could result in in-depth training and a delay in their participation with the group. Oh, and not to mention lack of sleep due to the training.

John

http://thechart.blogs.cnn.com/2012/09/26/company-recalls-products-in-wake-of-salmonella-outbreak/?hpt=hp_bn12

"Snip"

Sunland, Inc., has expanded its voluntary recall to include all of the products manufactured at its peanut butter and nut manufacturing plant in Portales, New Mexico.

The plant was shut down on Saturday, after Trader Joe's recalled its Creamy Salted Valencia Peanut Butter because it was linked to potential contamination with Salmonella, according to Katalin Coburn, Sunland's vice president for media relations.

This company says the recall applies to the all products manufactured at this plant with a "best if used by" date between May 1, 2013 and September 24, 2013. Consumers can find this date stamped on the side of the jar's label below the lid of the jar.

John

http://www.cpsc.gov/cpscpub/prerel/prhtml12/12282.html

FOR IMMEDIATE RELEASE

September 26, 2012

Release #12-282

Firm's Recall Hotline: (866) 244-5687

CPSC Recall Hotline: (800) 638-2772

CPSC Media Contact: (301) 504-7908

Big Lots Recalls Garden Swings Due to Fall Hazard

WASHINGTON, D.C. - 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. It is illegal to resell or attempt to resell a recalled consumer product.

Name of Product: Wilson & Fisher Garden Swings

Units: About 6,900

Importer: Big Lots, of Columbus, Ohio

Manufacturer: Anji Jiayi Garden Supplies Company, Xiaofeng Town, China

Hazard: The wooden swing’s seat can break while in use, posing a fall hazard to the consumer.

Incidents/Injuries: Big Lots has received 14 reports of swing seats breaking, resulting in four reports of back pain and five reports of scratches and scrapes.

Description: This recall involves Wilson & Fisher log-style swing sets sold in a natural wood finish. The swing’s two-person bench seat is suspended between two wooden A-frame supports. Assembly instructions sold with the swings have item number JY1107 and SKU number 210020400 printed on the sheet.

Sold exclusively at: Big Lots stores nationwide from March 2012 through June 2012 for about $130.

Manufactured in: China

Remedy: Consumers should immediately stop using the recalled swing sets, detach the bench seat and return it to any Big Lots store for a full refund. Consumers should destroy the remaining components.

Consumer Contact: For additional information, contact the firm toll-free at (866) 244-5687 between 9 a.m. through 5 p.m. ET Monday through Friday, or visit the firm’s website at www.biglots.com and click on recalls.

John

http://www.cpsc.gov/cpscpub/prerel/prhtml12/12281.html

FOR IMMEDIATE RELEASE

September 25, 2012

Release #12-281

Firm's Recall Hotline: (877) 808-8154

CPSC Recall Hotline: (800) 638-2772

CPSC Media Contact: (301) 504-7908

Specialized Bicycle Components Recalls Bicycles Due to Fall and Injury Hazards

WASHINGTON, D.C. - 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. It is illegal to resell or attempt to resell a recalled consumer product.

Name of Product: Bicycles

Units: About 12,000

Distributor: Specialized Bicycle Components Inc., of Morgan Hill, Calif.

Manufacturer: Kinesis, of China

Hazard: The front fork can break, posing fall and injury hazards to riders.

Incidents/Injuries: Specialized has received four reports of front forks breaking, resulting in facial fractures, head and shoulder injuries and cuts.

Description: This recall involves some 2008 and 2009 models women's and men's Globe model bicycles. Recalled models include the Globe Elite, Globe Sport, Globe Sport Disc, Globe Centrum Comp, Globe Centrum Elite, Globe City 6, Globe Vienna 3, Globe Vienna 3 Disc, Globe Vienna 4, Globe Vienna Deluxe 3, Globe Vienna Deluxe 4, Globe Vienna Deluxe 5 and Globe Vienna Deluxe 6 bicycles. The bicycles were sold in various colors, including gun, silver, black, khaki, navy, bone, blue, charcoal, burgundy and gold. The brand name "Specialized" is on the lower frame tube and the model name is on various locations on the bicycle frame.

Sold at: Authorized Specialized retailers nationwide from July 2007 to July 2012 for between $550 and $1,100.

Manufactured in: China

Remedy: Consumers should immediately stop riding these bicycles and return them to an authorized Specialized retailer for the free installation of a free replacement fork.

Consumer Contact: For additional information, contact Specialized toll-free at (877) 808-8154 from 8 a.m. to 5 p.m. PT Monday through Friday, or visit the company's website at http://www.specialized.com and click on Support/Safety Notices.

John