/* mobile /* end mobile MEDDESKTOP: January 2008

Thursday, January 31, 2008

NuCel Labs Announces Nationwide Recall of NuCel Labs Eye Drops and Eye/Ear Wash Products

FDA news lead me to the following recall notice by NuCel Labs of Idaho Falls. The reason for recall is that the products contain bacteria and other particles thus proving to be non-sterile. If you use any of these products, please follow the guide lines.

Nationwide Recall of NuCel Labs Eye Drops and Eye/Ear Wash Products

Contact:
Kevin Lundquist
208-542-0325

FOR IMMEDIATE RELEASE -- January 29, 2008 -- NuCel Labs of Idaho Falls, Idaho announced today that it is conducting a voluntary nationwide recall of all Eye Drops and Eye/Ear Wash. This recall follows an FDA inspection in which product testing indicated that there was bacteria and particulate matter in the product deeming these products non-sterile. Non-sterile eye drops pose an unacceptable risk of causing eye infections, which in rare cases could lead to blindness.

Products are packaged in 1/4 oz plastic bottles. Eye drops are labeled: Eye Drops Caution: Do Not Use With Implants. Wash is labeled Eye/Ear Wash. All products labeled "Eye Drops Caution: Do Not Use With Implants" or "Eye/Ear Wash" are subject to the recall action. There are no lot numbers or expiration dates on the product. Approximately 500 units of these products have been distributed nationwide through retail outlets and the internet.

No illnesses or injuries have been reported to date.

The company has ceased the production and distribution of the product. Consumers who may have any of these products on hand are advised not to use them. Consumers are asked to return them to NuCel Lab, 1380 Curtis Ave, Idaho Falls, Idaho 83402 or discard them and send NuCel Lab a purchase receipt for a full. Consumers with questions may call NuCel Lab at 208-542-0325.


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CPSC Recalls For 31st January, 2008


bullet Baby Sterling Silver Teethers Recalled by Elegant Baby Due to Choking Hazard
In cooperation with the U.S. Consumer Product Safety Commission (CPSC), Elegant Baby and Baby Needs Inc., of Burlington, N.C., is voluntarily recalling about 200 Heart and Car Sterling Silver Teethers. The hearts and cars on the teethers can break off, posing a choking hazard to infants.
bullet Girls' Hooded Jackets with Drawstrings Sold Exclusively at Marshalls Stores Recalled by Apollo Jeans Due to Strangulation Hazard
In cooperation with the U.S. Consumer Product Safety Commission (CPSC), AJBlue LLC, dba Apollo Jeans, of New York, N.Y., is voluntarily recalling about 14,000 Girls’ Hooded Jackets. The jackets have a drawstring through the hood which poses a strangulation hazard to children. In February 1996, CPSC issued guidelines to help prevent children from strangling or getting entangled on the neck and waist by drawstrings in upper garments, such as jackets and sweatshirts.
bullet RR Donnelley Recalls Classroom Reading and Math Aids Due to Violation of Lead Paint Standard
In cooperation with the U.S. Consumer Product Safety Commission (CPSC), RR Donnelley, of Chicago, Ill., is voluntarily recalling about 185,000 Classroom Reading and Math Aids. Surface paint on the products contains excessive levels of lead, violating the federal lead paint standard.
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Wednesday, January 30, 2008

Vending machines (MVM) that dispense medical marijuana.

Vending machines that dispense medical marijuana.
Available at:
Melrose Quality Pain Relief, 4906 Melrose Ave, Mid-Wilshire; 323.957.7777

Herbal Nutrition Center, 1435 S. La Cienega Blvd. Suite G, Mid-Wilshire; 310.855.9484


Most of your essentials are already distributed by vending machines: condoms, electronics, luscious 1-calorie Tab... But now, you can finally get what you really need: medical marijuana, from Anytime Vending Machines.
But to use the AVMs, you need to;
• Bring your prescriptions for approval at the AVMs, housed in enclosed room guarded 24/7.
• You are fingerprinted and photographed.
• You receive a pre-paid credit carded loaded with their individual profiles.
• You choose their dosage (3.5 grams or 7 grams) and one of five strains of marijuana.
• The marijuana is in capsule form and dispensed in vacuum-sealed packages.
• You can buy no more than 1 ounce a week.
What is this medical marijuana? here is an explanation.

source
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Fetal Doppler Lets You Hear And Monitor Your Unborn Baby.

Fetal Doppler system for home use is a anytime heartbeat monitoring the baby in the womb. As one of the most wonderful things could happen to a woman might be pregnancy, and many may have missed a heart beat when they heard the little heartbeat the first time. With a fetal Doppler, you can repeat that experience any time you want anytime anywhere. Following is a news release about mother who manage to have a peace of mind through four pregnancies.


WEBWIRE – Wednesday, January 30, 2008
After three heartbreaking miscarriages, Jacqueline Harris is certainly no stranger to the worry and fear that comes along with each new, hopeful pregnancy. After discovering a medical device known as a fetal heart doppler monitor, which allows one to hear a baby’s heartbeat from inside the womb, Harris was thrilled with the peace of mind this little piece of technology brought. Happily, Jacqueline is now the mother of four healthy children and desperately wanted to find a way to share her newfound knowledge of baby doppler monitors and the peace of mind they bring with the rest of the world, which led to the launch of her new site DopplerFetal.net.

Jacqueline says, "The FDA regulates the sale of baby dopplers and has deemed them safe for use. There are many legitimate companies out there doing business, but there are still those making a profit from selling the equipment illegally, and without the required prescription" Feeling strongly about providing the vital information people must know before purchasing their own doppler monitor, Harris launched her new site so all parents could be empowered with the knowledge they really need.

With in depth articles, tips, product reviews, and medical information about ultrasound technology, the site aims to fully enlighten parents-to-be about the benefits of fetal heart dopplers, and "how they help to make the experience of pregnancy even more wonderful than it already is" said Harris.

As Jacqueline found out during her research, consumers also need to be aware of "dopplers" that are labeled as a medical device, when in reality, they’re nothing more than "powerful microphones with medical grade prices and poor quality" said Harris who went on to say, "These are just some of the important things I wanted to be sure all consumers knew about"

For more useful information and helpful facts about purchasing or renting fetal heart dopplers, visit the site at http://www.dopplerfetal.net.


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Dollar Tree Stores Recalls Glue Guns

FOR IMMEDIATE RELEASE
January 29, 2008
Release #08-175

Firm’s Recall Hotline: (800) 876-8077
CPSC Recall Hotline: (800) 638-2772
CPSC Media Contact: (301) 504-7908


Glue Guns Recalled by Dollar Tree Stores Due to Fire, Burn and Shock 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.

Name of Product: Crafters Square Hot Melt Mini Glue Guns

Units: About 253,000

Retailer: Dollar Tree Stores Inc., of Chesapeake, Va.

Importer: Greenbrier International Inc., of Chesapeake, Va.

Hazard: The recalled glue guns can short circuit, causing the gun to smoke and catch fire. This poses fire, burn and shock hazards to consumers.

Incidents/Injuries: Dollar Tree is aware of seven incidents in which these glue guns short circuited resulting in two injuries, including electrical shock and burns.

Description: The glue guns dispense hot glue and are intended for craft projects. The recalled glue gun is black with a yellow trigger and is approximately 4 1/2 inches from the back of the gun to the tip. Attached is a 44-inch electrical cord. "Crafters Square" and product number 818261-72 or 818261-75 are located on the guns' packaging.

Manufactured in: China

Sold at: Dollar Tree, Dollar Bill$, Dollar Express, Greenbacks, Only One $1, and Deal$ stores nationwide from February 2007 through August 2007 for about $1.

Remedy: Consumers should immediately stop using the recalled glue guns and return them to the store where purchased for a full refund.

Consumer Contact: For additional information, contact Dollar Tree Stores Inc. at (800) 876-8077 between 9 a.m. and 5 p.m. ET Monday through Friday, or visit the firm’s Web site at www.dollartree.com


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Tuesday, January 29, 2008

California State Senate Rejects Universal Healthcare

SACRAMENTO -- Gov. Arnold Schwarzenegger's audacious plan to arrange medical insurance for nearly all Californians -- one watched as a potential model for the nation -- was rejected Monday by the state Senate, obliterating the chance of anything but piecemeal healthcare changes from the Legislature this year.

The Senate Health Committee voted down the $14.9-billion proposal, which would have required people to hold private insurance and subsidized the premiums for those who could not afford them. The repudiation came from Republicans and Democrats, with only one of 11 senators backing the plan that Schwarzenegger and Assembly Speaker Fabian Nuñez (D-Los Angeles) spent much of 2007 putting together.

LA Times Article.
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Flu Shots Without Needles! Via Mucosal delivery.

If you are like me, who cringes even to see a needle, is going to be presented with good news. We might be able to receive the flu vaccine without needles. According to new research conducted by an International team of researchers from Korea, Japan and France, we might receive the flu doze in the future through our noses or just dropping it under our tongues. Mucosal delivery, where the vaccine is administered in either the mouth or nose, is very welcomed by some health professionals - in part because it makes it so much easier to deliver, than trying to stab a child with a needle.
Experiments on mice showed that delivering the vaccine "sublingually" protected the rodents against flu without any obvious side-effects. It is thought this method may prove more effective than jabs as it protects the area where the virus first enters. The study appears in the Proceedings of the National Academy of Sciences.
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Monday, January 28, 2008

Shiloh Farms Recalls Shiloh Farms Organic Unhulled Sesame Seeds Due To Salmonella Risk

FDA Announced today that Shiloh farms of New Holland, Pennsylvania has recalled "Shiloh Farms Organic Unhulled Sesame Seeds" Because of Possible Salmonella contamination.

Shiloh Farms Recalls "Shiloh Farms Organic Unhulled Sesame Seeds" Because of Possible Health Risk

Contact:
Peter Horvath
(800) 362-6832 xt102

FOR IMMEDIATE RELEASE -- New Holland, PA – January 28, 2008 – Shiloh Farms, of New Holland, Pennsylvania, is recalling Shiloh Farms Organic Unhulled Sesame Seeds, 12-oz., because it may be contaminated with Salmonella.

Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people and others with weakened immune systems.Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstance, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis. Consumers with the above symptoms should consult their physician.

No illnesses have been reported in connection with this product.

This product comes in a 12 oz blue and white 5” x 8” plastic bag with a Shiloh Farms logo and USDA organic symbol. The UPC bar code number is 047593303545. The firm’s name and address appears on the back of the plastic bag. Product distributed between November 1, 2007 and January 25, 2008 is being recalled. Only product with lot codes 17503 and 17133 are affected.

The contamination was identified when FDA testing revealed the presence of salmonella in a sample of organic sesame seeds from a Shiloh Farms supplier.

The recalled Shiloh Farms product was distributed to a total of 98 health food stores located in New York, Connecticut, New Jersey, Massachusetts, Virginia, Pennsylvania, Maryland and Arkansas.

The company is asking stores to discontinue distribution of this product and to promptly return the product and stock on hand to the company for credit. Consumers should not consume this product and return this product to the point of purchase for a refund.

Consumers with questions may contact Shiloh Farms, (800) 362-6832.


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Sunday, January 27, 2008

Perdue Farms, Inc., Recalls Chicken Products due to Undeclared Allergen

Recall Release CLASS I RECALL
FSIS-RC-003-2008 HEALTH RISK: HIGH

Congressional and Public Affairs
(202) 720-9113
Peggy Riek

WASHINGTON, Jan 26, 2008 - Perdue Farms, Inc., an Accomac, Va., establishment, is recalling approximately 24,710 pounds of boneless, skinless chicken breast products because they may contain an undeclared allergen. The products contain an Italian seasoning which includes milk, a known allergen, which is not declared on the label.

The following products are subject to recall: [View Labels (PDF Only)]
  • 28.8-ounce packages of “PERDUE Perfect Portions, 6 Individually Wrapped Boneless Skinless Chicken Breasts.” Each package bears the establishment number “EST. P-7903” inside the USDA mark of inspection as well as the UPC code “72745-06819.” Each package also bears a “Sell-by or Freeze-By” date of “FEB 02,” “FEB 03,” “FEB 04,” “FEB 05” or “FEB 06.”

The chicken products were produced on Jan.19, 2008, and were distributed to retail establishments in Connecticut, Florida, Georgia, Illinois, Maryland, Massachusetts, New Jersey, New York, North Carolina, Pennsylvania and Virginia.

The problem was discovered by the company. FSIS has received no reports of illness due to consumption of these products. Anyone concerned about an allergic reaction should contact a physician.

Media with questions about the recall should contact company Vice President of Corporate Communication Julie DeYoung at (410) 543-3166. Consumers with questions about the recall should contact the Perdue Consumer Relations hotline at (800) 473-7383.

Consumers with food safety questions can "Ask Karen," the FSIS virtual representative available 24 hours a day at AskKaren.gov. The toll-free USDA Meat and Poultry Hotline 1-888-MPHotline (1-888-674-6854) is available in English and Spanish and can be reached from l0 a.m. to 4 p.m. (Eastern Time) Monday through Friday. Recorded food safety messages are available 24 hours a day.

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Saturday, January 26, 2008

Domega International Ltd., Inc. recalls Zebra brand sweetened lotus root seed and Zebra brand sweetened coconut

Domega International Ltd., Inc. Issues Alert on Undeclared Sulfites in Zebra Brand Sweetened Lotus Root Seed and Zebra Brand Sweetened Coconut

Contact:
Jing Hua Chen
646-938-7345

FOR IMMEDIATE RELEASE -- January 25, 2008 -- DOMEGA INERNATIONAL LTD., INC., 98 Bay 35th Street, Brooklyn, NY 11214 is recalling Zebra brand sweetened lotus root seed and Zebra brand sweetened coconut, because it contains undeclared sulfites. People who have severe sensitivity to sulfites run the risk of serious or life-threatening reactions if they consume this product.

The recalled Zebra brand sweetened lotus root seed is sold in 6 oz. un-coded plastic bags and is a product of China, packed by Hong Kong Ever Time Food & Grocery Co. Ltd. The product was sold nationwide.

The recalled Zebra brand sweetened coconut is sold in 6 oz. un-coded plastic bags and is a product of China, packed by Hong Kong Ever Time Food & Grocery Co. Ltd. The product was sold nationwide.

The recall was initiated after routine sampling by New York State Department of Agriculture and Markets Food Inspectors and subsequent analysis by Food Laboratory personnel revealed the presence of undeclared sulfites in Zebra brand sweetened lotus root seed and Zebra brand sweetened coconut which did not declare sulfites on the label. The consumption of 10 milligrams of sulfites per serving has been reported to elicit severe reactions in some asthmatics. Anaphylactic shock could occur in certain sulfite sensitive individuals upon ingesting 10 milligrams or more of sulfites.

No illnesses have been reported to date in connection with this product. Consumers who have purchased Zebra brand sweetened lotus root seed and Zebra brand sweetened coconut should return them to the place of purchase. Consumers with questions may contact the company at 1-646-938-7345.


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AM2 PAT, Inc., issues nationwide recall of all pre-filled syringe flushes

FDA today released a public warning and nationwide recall of contaminated syringes by AM2 PAT, Inc. These are pre-filled flush syringes with heparin and saline that have been found to be contaminated with Serratia marcescens, a bacterium that can cause serious injury or death. This is an update to an earlier recall of the same products.


FOR IMMEDIATE RELEASE
January 25, 2008

Media Inquiries:
Peper Long, 301-827-6242
Consumer Inquiries:
888-INFO-FDA


FDA Warns Public of Contaminated Syringes
AM2 PAT, Inc., issues nationwide recall of all pre-filled syringe flushes

The U.S. Food and Drug Administration (FDA) today announced a nationwide recall of all lots of heparin and saline pre-filled flush syringes manufactured by AM2 PAT, Inc., of Angier, N.C. Two lots have been found to be contaminated with Serratia marcescens, a bacterium that can cause serious injury or death.

These syringes are manufactured by AM2 PAT under the brand names Sierra Pre-filled, Inc. and B. Braun. They are sold in fill sizes of 3mL, 5mL and 10mL and syringe sizes of 6mL and 12mL.

Consumers and health care facilities with any of the recalled, pre-filled Heparin Lock or Normal Saline IV Flush syringes should stop using the product immediately. Health care facilities should immediately quarantine the products in their inventory and return them to their distributor. Individual consumers should return them to the location from which they were received, such as a pharmacy or hospital. They should also let their health care providers know that they have been exposed to syringes recalled by FDA.

The recall affects all lots of these products. The FDA received information that Heparin Lock Flush syringes from Lot 070926H and Normal Saline IV syringes from Lot 070917A have been found to be contaminated with Serratia marcescens, and have resulted in patient infections. The U.S. Centers for Disease Control and Prevention has confirmed growth of Serratia marcescens from unopened heparin syringes.

Traditionally, Serratia marcescens, a bacterium found in water and soil has been linked to pneumonia, blood infections, and urinary tract and wound infections. Some patients exposed to the recalled syringes have developed blood infections.

The company voluntarily recalled these products on Jan. 18 after confirming bacterial contamination in some user samples.

Consumers with questions may contact Sierra Pre-Filled at 919-552-9689, Monday through Friday, 10 a.m. to 5 p.m. EST.

Any adverse reactions experienced with the use of the products, and/or quality problems should also be reported to the FDA's MedWatch Program by phone at 800-FDA-1088, by fax at 800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, M.D. 20852-9787, or on the MedWatch Web site at www.fda.gov/medwatch.

MANUFACTURER: Sierra Pre-Filled, Inc., Angier, N.C.

PRODUCT DESCRIPTION:
Heparin Lock Flush Solution USP, All Strengths and Sizes
Normal Saline IV Flush Solution USP, All Strengths and Sizes

Sierra Pre-Filled Inc. Products:

NDC#

CATALOG #

Product

64054-1003-02

1003-02

Heparin Lock Flush 100units/mL 5mL

64054-1003-01

1003-01

Heparin Lock Flush 100units/mL 3mL

64054-3005-02

3005-02

Heparin Lock Flush 10units/mL 5mL

64054-3003-02

3003-02

Heparin Lock Flush 10units/mL 3mL

64054-3003-06

3003-06

Heparin Lock Flush 10units/mL 3mL (6mL syringe)

64054-3005-06

3005-06

Heparin Lock Flush 10units/mL 5mL (6mL syringe)

64054-0910-2

0910-12

Normal Saline IV Flush 10mL

64054-0905-2

0905-12

Normal Saline IV Flush 5mL

64054-0903-2

0903-12

Normal Saline IV Flush 3mL

B. Braun Products:

NDC#

CATALOG #

Product

64054-3005-02

513610

Heparin Lock Flush 10units/mL 5mL

64054-1003-01

513611

Heparin Lock Flush 100units/mL 3mL

64054-1003-02

513612

Heparin Lock Flush 100units/mL 5mL

64054-0903-2

513584

Normal Saline IV Flush 3mL

64054-0905-2

513586

Normal Saline IV Flush 5mL

64054-0910-2

513587

Normal Saline IV Flush 10mL

#


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Entire Synthetic Genome Stitched Together

Stitching DNA, yes it is not the same stitching your Grandma with clothes or your doctor with your gashes did. It is a whole new type of stitching according to a National Geographic Article.
Scientists yesterday announced that they have successfully created an entire synthetic genome in the lab by stitching together the DNA of the smallest known free-living bacterium, Mycoplasma genitalium. Experts are hailing the research as an important breakthrough in genetic manipulation that will one day lead to the "routine" creation of synthetic genomes—possibly including those of mammals.
This type of accomplishments would then allow scientists to create synthetic life-forms that may one day produce biofuels, clean up toxic waste, and fight global warming.
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Friday, January 25, 2008

Early Communication about an Ongoing Review of Vytorin By FDA

FOR IMMEDIATE RELEASE
January 25, 2008

Media Inquiries:
Susan Cruzan, 301-827-6242
Consumer Inquiries:
888-INFO-FDA


FDA Issues Early Communication about an Ongoing Review of Vytorin

The U.S. Food and Drug Administration today issued an Early Communication regarding the agency’s ongoing review of Vytorin based on preliminary results from a recently completed study – the Effect of Combination Ezetimibe and High-Dose Simvastatin vs. Simvastatin Alone on the Atherosclerotic Process in Patients with Heterozygous Familial Hypercholesterolemia (ENHANCE) – on this cholesterol lowering drug. Vytorin contains both Zetia (ezetimibe) and Zocor (simvastatin) in one tablet.

The FDA is informing the public that the agency will conduct a review of Merck and Schering Plough’s recent trial once the FDA receives the final study results.

Merck/Schering Plough Pharmaceuticals issued a press release reporting preliminary results of the study and stated that the study demonstrated no significant differences between the combination product and Zocor on the build up of cholesterol plaque in the carotid (neck) arteries. The study was not designed to detect any difference in risk of having a heart attack or stroke between the two treatments. An ongoing trial called -- Improved Reduction of Outcomes: Vytorin Efficacy International Trial (IMPROVE IT) -- is underway which is designed to evaluate the effect of Vytorin versus Zocor on heart disease and stroke.

This Early Communication is in keeping with the FDA's commitment to inform the public about its ongoing review of drugs. Until the FDA reviews the data, the agency advises patients to talk with their health care providers if they have questions about the ENHANCE study.

Full text of the Early Communication about an Ongoing Data Review for the ENHANCE Study can be found at: http://www.fda.gov/cder/drug/early_comm/ezetimibe_simvastatin.htm.


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Seoul Shik Poom, Inc. Recalls Frozen Salted Yellow Croaker and / or Frozen Dried Yellow Croaker

Seoul Shik Poom, Inc. Recalls Frozen Salted Yellow Croaker and/or Frozen Dried Yellow Croaker Because of Possible Health Risk

Contact:
BJ Lee
(908) 810-7230

FOR IMMEDIATE RELEASE -- January 23, 2008 -- Seoul Shik Poom, Inc. of Hillside, NJ is recalling the following products because they have the potential to be contaminated with Clostridium botulinum, a bacterium, which can cause life-threatening illness or death:

Item #

Description

Weight (lbs)

BG1103

Bupsungpo) Fz. Salted Yellow Croaker (bag)

2.2Lbs

BG1121B

Polar) Fz. Dried Yellow Croaker (bag)

4.5Lbs

BG1121

Polar) Fz. Dried Yellow Croaker (bag)

2.2Lbs

BG1122B

Polar) Fz. Dried Yellow Croaker (bag)

4.5Lbs

BG1124

Choripdong) Fz. Yellow Croaker (bulk box)

29.73Lbs

BG1124A

Choripdong) Fz. Yellow Croaker (bulk box)

31.6Lbs

BG1123

Choripdong) Fz. Yellow Croaker (bulk box)

30.83Lbs

Consumers are warned not to use these products even if they do not look or smell spoiled.

Botulism, a potentially fatal form of food poisoning, can cause the following symptoms: general weakness, dizziness, double-vision, and trouble with speaking or swallowing. Difficulty in breathing, weakness of other muscles, abdominal distension and constipation may also be common symptoms. People experiencing these problems should seek immediate medical attention.

Frozen Salted/Dried Yellow Croaker was distributed in New York, New Jersey and Maryland area. It reached consumers through retail stores. This product comes in a clear plastic bag and is individually tied with rope.

The potential for contamination was noted after routine testing. No illnesses have been reported to date in connection with this problem.

Consumers who have purchased these Frozen Salted/Dried Yellow Croaker products are urged to return them to the place of purchase for a full refund. Consumers with questions may contact Seoul Shik Poom, Inc. at (908) 810-7230.


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CPSC Recalls For 25th January 2008


bullet Toy Wooden Block and Train Sets Recalled By Christmas Tree Shops Due to Violation of Lead Paint Standard
In cooperation with the U.S. Consumer Product Safety Commission (CPSC), Christmas Tree Shops, of South Yarmouth, Mass., is voluntarily recalling about 15,000 Big Wooden Blocks and Jumbo Wooden Train Sets. Surface paint on some pieces of the toys contains excessive levels of lead, violating the federal lead paint standard.
bullet Brian Smith Recalls Serene Float Tanks Due to Electrocution Hazard
In cooperation with the U.S. Consumer Product Safety Commission (CPSC), Brian Smith, dba Serene Float Tanks, of Lakewood, Calif., is voluntarily recalling 5 Serene Float Tanks. Electrical components in the float tank are not grounded, which can prevent the Ground Fault Circuit Interrupter (GFCI) from tripping when needed, posing an electrocution hazard to consumers.
bullet RR Donnelley Recalls Educational Assessment Blocks Due to Violation of Lead Paint Standard
In cooperation with the U.S. Consumer Product Safety Commission (CPSC), RR Donnelley, of Chicago, Ill., is voluntarily recalling about 18,000 sets of ESI-R Screening Materials. Surface paint on the green wooden blocks contains excessive levels of lead, violating the federal lead paint standard.
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Thursday, January 24, 2008

Dannon sued for claims!

Found at LA Times;
In a lawsuit filed Wednesday in U.S. District Court in Los Angeles, Trish Wiener accuses the yogurt maker, Dannon , of a "massive and comprehensive" false advertising campaign. The Suit said Dannon’s own studies failed to support its advertised claims that its Activia, Activia Light and DanActive were “clinically” and “scientifically” “proven” to have health benefits that other yogurts did not.

Dannon promotes them as clinically proven to help regulate digestion and boost immunity because they contain bacteria that Wiener's suit says aren't so special. "You're hearing these scientific terms and you're thinking that they have come up with something," said the Northridge resident, who owns a catering company. "But the only effect that it had on me was that it tasted poorly."
The suit seeks class-action status and demands that Dannon give refunds to everyone in the U.S. who purchased the products -- an amount that a lawyer for Wiener said could be as much as $300 million.
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Japan's Fisheries Agency says mercury found in tuna is not a health threat

Jan. 24 (Bloomberg) -- Japan's Fisheries Agency said mercury found in tuna is not at levels that pose a health threat, disputing a report in the New York Times yesterday that mercury in tuna sold in Manhattan exceeded safety levels.

The newspaper said tuna sushi servings it bought were tested in laboratories and some contained 1.4 parts per million of methyl mercury, in excess of the Food and Drug Administration's limit of 1 part per million. Both the U.S. and European Union use the same limit, the paper said.

Japan, the world's biggest market for tuna, isn't taking any action in response to the report because the government doesn't consider the reported mercury levels dangerous, said Teruo Tagaki, the chief of the Fisheries Agency's products safety office.

``The newspaper is exaggerating the risk,'' he said, adding Japan's government is aware some tuna contains more than 1 part per million of mercury. Tagaki cited a 2005 study by Japan's Food Safety Commission that found ingesting as much as 100 micrograms of mercury each week presented no risk to health for a person weighing 50 kilograms. Japan hasn't set a parts-per-million limit on mercury content in tuna, he said.

The New York Times report said eating six pieces of the sushi it tested would result in consumption of more than 49 micrograms of mercury. That's the amount the Environmental Protection Agency considers acceptable for weekly consumption over a period of several months by an adult of average weight.

Bloomberg Article


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Battat Recalls Magnetic Construction Sets



FOR IMMEDIATE RELEASE
January 23, 2008
Release #08-173

Firm’s Recall Hotline: (800) 247-6144
CPSC Recall Hotline: (800) 638-2772
CPSC Media Contact: (301) 504-7908


Battat Recalls Magnetic Construction Sets; Ingested Magnets Pose Aspiration and Intestinal 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.

Name of Product: Battat Magnabild Magnetic Building Systems

Units: About 125,000

Distributor: Battat Inc., of Plattsburgh, N.Y.

Hazard: Small magnets inside the building pieces can fall out. Magnets found by young children can be swallowed or aspirated. If more than one magnet is swallowed, the magnets can attract each other and cause intestinal perforations or blockages, which can be fatal.

Incidents/Injuries: CPSC and Battat have received 16 reports of magnets coming out of the long flexible rods, 1-inch rods, and of the corners of square building pieces. No injuries have been reported.

Description: This recall involves the 293-piece (item number BB1502H) and the 180-piece (item number BB1431H) Magnabild Magnetic Building System sets. Both sets come in rotating display cases that contain 1-inch and 4-inch rods with magnets, curved 1-inch rods, triangle and square pieces with magnets, square-shaped plastic building pieces, triangles and 5-sided pieces, and metal balls. The pieces come in different colors. All of the plastic building pieces, except the 4-inch flexible rods, have the word “Magnabild” in raised lettering on them. The item number is found on a hang tag attached to the set. The product is designed for children older than three years.

Manufactured in: China

Sold at: Various retailers nationwide and online sellers from 2005 through 2007 for between $30 and $40.

Remedy: Consumers should immediately take the recalled Magnabild Magnetic Building System away from children and contact Battat to receive a pre-paid mailer to return the toy and to receive a free replacement product.

Consumer Contact: For additional information, contact Battat at (800) 247-6144 between 8 a.m. and 4:30 p.m. ET Monday through Friday or visit the firm’s Web site at www.battatco.com


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OKK Trading Recalls Toy Racing Cars


FOR IMMEDIATE RELEASE
January 23, 2008
Release #08-172

Firm’s Recall Hotline: (877) 655-8697
CPSC Recall Hotline: (800) 638-2772
CPSC Media Contact: (301) 504-7908


Toy Racing Cars Recalled by OKK Trading 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.

Name of Product: Toy Racing Cars

Units: About 2,000

Manufacturer: OKK Trading Inc., of Commerce, Calif.

Hazard: Surface paint on the toy cars contains excessive levels of lead, violating the federal lead paint standard.

Incidents/Injuries: None reported.

Description: This recall involves toy racing cars that are operated with a remote control. The toy racing car comes with four additional tires and one remote control. “Formula 1” is printed on the packaging.

Manufactured in: China

Sold at: Retail dollar and discount stores nationwide from October 2007 through November 2007 for about $1.

Remedy: Consumers should immediately take this car away from children and return it to the store where purchased for a refund.

Consumer Contact: For additional information, contact the company toll-free at (877) 655-8697 between 8:30 a.m. and 5:30 p.m. PT Monday through Friday, or visit the firm’s Web site at www.okktrading.com



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Wednesday, January 23, 2008

Acceleron Pharma Receives Grant for ACE-011 from the Multiple Myeloma Research Foundation

Acceleron Pharma Receives Grant for ACE-011 from the Multiple Myeloma Research Foundation

Company Advances ACE-011 into a Multiple Dose Study

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Acceleron Pharma, Inc., a biopharmaceutical company developing novel therapeutics that modulate the growth of tissues including bone and muscle, today announced that it was selected to receive a Biotech Investment Award from the Multiple Myeloma Research Foundation to support the research and development of ACE-011, a novel bone forming agent, for the treatment of multiple myeloma. In addition, Acceleron announced that it began a randomized, double-blind, placebo-controlled multiple ascending dose study of ACE-011.

We are proud to receive this highly-regarded grant from the Multiple Myeloma Research Foundation, said John Knopf, Ph.D., Chief Executive Officer of Acceleron. With this grant, we will continue to aggressively pursue the development of ACE-011, which has shown encouraging preclinical and clinical effects on bone formation, to treat the complications of bone loss associated with multiple myeloma.

The multiple dose study will be conducted in healthy, post-menopausal women. Subjects will receive four monthly subcutaneous doses of either ACE-011 or placebo. The primary objective of the study is to assess the safety, tolerability and pharmacokinetics of ACE-011. The pharmacodynamic effects of ACE-011 on bone will also be measured.

We are excited to start this study with ACE-011 and expect to begin additional studies with this compound later this year for the treatment of cancer and cancer-related bone loss, said Matthew L. Sherman, M.D., Chief Medical Officer of Acceleron. Our product pipeline continues to make great progress and we look forward to announcing additional clinical milestones throughout 2008.

About ACE-011

ACE-011, a protein therapeutic based on the activin receptor type IIA, is a novel bone forming agent. In numerous preclinical models of bone loss, ACE-011 increased bone mineral density, improved bone architecture, increased the mineral apposition and bone formation rates and improved bone mechanical strength. These effects have been demonstrated in therapeutic models of bone loss in which ACE-011 stimulated bone formation a significant unmet medical need that is underserved by current treatments for bone loss. ACE-011 is currently in a phase 1b study and Acceleron expects to begin a phase 2a study in multiple myeloma in the middle of 2008.


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Animal Cloning Myths Per FDA

The responses to the questions provided in this document represent the FDA’s view in light of the conclusions and recommendations outlined in the Animal Cloning Risk Assessment, Risk Management Plan, and Guidance for Industry #179.


Myth: Cloning is a new technology.

Actually, cloning isn’t new at all. In fact, we eat fruit from plant clones all the time, in the form of bananas and grafted fruits. We’ve been cloning plants for decades, except that we refer to it as “vegetative propagation.” It takes about 30 years to breed a banana from seed, so, to speed the process of getting fruit to market, most bananas, potatoes, apples, grapes, pears, and peaches are from clones.

Some animals can reproduce themselves by vegetative propagation, including starfish and other relatively simple sea creatures. Amphibians such as frogs first underwent cloning in the 1950s. Identical twin mammals can be thought of as naturally occurring clones, but producing clones of mammals in the laboratory is relatively new. Using cells from animal embryos to make clones has been has been around since the early 1990s, but the first animal cloned from a cell from an adult animal was Dolly the sheep, who was born in 1996.

Myth: Clones are a specific animal’s DNA grafted onto another body.

Absolutely not. Despite science fiction books and movies, clones are born just like any other animal. The only difference is that clones don’t require a sperm and egg to come together to make an embryo. Clone embryos are made by using a whole cell or cell nucleus from a donor animal and fusing it to an egg cell that’s had its nucleus removed. That embryo is implanted into the uterus of a surrogate dam (a livestock term that breeders use to refer to the female parent of an animal) to grow just as if it came from embryo transfer or in vitro fertilization.

Myth: Offspring of clones are clones, and each generation gets weaker and weaker and has more and more problems.

No, not at all. A clone produces offspring by sexual reproduction just like any other animal. A farmer or breeder can use natural mating or any other assisted reproductive technology, such as artificial insemination or in vitro fertilization to breed clones, just as they do for other farm animals. The offspring are not clones, and are the same as any other sexually-reproduced animals.

Myth: Clones are always identical in looks.

Not necessarily. In fact, many clones have slight variations in coat color and markings.

Let’s think about the identical twin calves again. They have the same genes, but look a little different. That’s because of the way those genes are expressed—that is, how the information in that gene is seen in the actual animal. For example, if they’re Holstein cows, the pattern of their spots, or the shape of their ears may be different. Human identical twins also have the same genes, but because those genes are expressed differently in each person, they have different freckle and fingerprint patterns.

Myth: Clones have exactly the same temperament and personality as the animals from which they were cloned.

Temperament is only partly determined by genetics; a lot has to do with the way an animal has been raised. It’s the old “nature versus nurture” argument.

Say you want to clone your horse because of his gentle and sweet temperament. Although your horse’s clone may be easy-going, he would have to have exactly the same life experiences as your original horse in order to have the same temperament.

Your original horse isn’t afraid of loud noises because his experiences have taught him that they won’t hurt him. But if your clone has a bad experience with loud noises (for instance, a tree branch falls on him in a loud thunderstorm and hurts him), he may associate loud noises with pain and be afraid of them.

Myth: When clones are born, they’re the same age as their donors, and don’t live long.

Clones are born the same way as other newborn animals: as babies. No one really knows what causes aging in mammals, but most scientists think it has to do with a part of the chromosome called a telomere that functions as a kind of clock in the cell. Telomeres tend to be long at birth, and shorten as the animal ages.

A study on Dolly (the famous sheep clone) showed that her telomeres were the shorter length of her (older) donor, even though Dolly was much younger. Studies of other clones have shown that telomeres in clones are shorter in some tissues in the body, and are age-appropriate in other tissues. Still other studies of clones show that telomeres are age-appropriate in all of the tissues. Despite the length of telomeres reported in different studies, most clones appear to be aging normally. In fact, the first cattle clones ever produced are alive, healthy, and are 10 years old as of January 2008.

Myth: Cloning results in severely damaged animals that suffer, and continue to have health problems all their lives.

The vast majority of swine and goat clones are born healthy, grow normally, and are no more susceptible to health problems than their non-clone counterparts. During the early days of what is known as assisted reproductive technologies in livestock, veterinarians noticed that some calf and lamb fetuses grew too large during pregnancy, and had serious birth defects. This set of abnormalities is referred to as “large offspring syndrome,” or LOS. These same abnormalities have also been seen in calf and lamb clones, and have received a lot of attention because they occur at what appear to be higher rates than observed with other assisted reproductive technologies. The syndrome seems to be related to processes that take place outside the body (during the in vitro phase. As producers understand more about the cloning process, the rate at which LOS is observed in calf and lamb clones has been decreasing. The same kind of decrease in LOS rates was observed as people who used technologies such as in vitro fertilization in cattle learned more about the process. LOS hasn’t been seen in swine or goat clones.

Most clones that are normal at birth become as strong and healthy as any other young animals. Calf and lamb clones with abnormalities at birth may continue to have health problems for the first few months of life. But after the age of six months, they’re completely indistinguishable in appearance and blood measurements from conventionally bred animals of the same age.

Myth: Cow clones make human pharmaceuticals in their milk.

Lots of people get this confused. The clones we’re talking about here are “just clones.” They don’t have any new genes added to them, and they don’t make pharmaceuticals (or any other non-milk substances) in their milk. They just do the same thing as their conventionally bred counterparts. Cows that make pharmaceuticals in their milk are genetically engineered—that is, they have new genes added to them. Some of these genetically engineered animals can be reproduced by cloning, which is why some people get confused about this concept.

Myth: When a chicken clone lays eggs, the chicks that hatch are clones.

Neither chickens nor any other kind of bird have been cloned yet. So far, mice, rats, rabbits, cattle (and the closely related but endangered gaurs and bantengs), swine, sheep, goats, deer, horses, mules, cats, and dogs are the mammals that have been cloned.

Myth: Meat from clones is already in the food supply.

FDA asked clone producers and breeders to voluntarily keep milk and meat from clones out of the food and feed supplies until we finish assessing their safety. To the best of our knowledge, they have done so. After years of detailed study and analysis, FDA has concluded that meat and milk from clones of cattle, swine, and goats, and the offspring of clones from any species traditionally consumed as food, are as safe to eat as food from conventionally bred animals. We don’t expect food from clones to enter the food supply in any great amounts any time soon, as these animals will be used for breeding.

The U.S. Department of Agriculture (USDA) believes that it is unlikely that products from these animals would enter the meat supply for several years. Meat and milk products from the progeny of animal clones are several years off. USDA will convene stakeholders to discuss efforts to provide a smooth and orderly market transition, as industry determines next steps with respect to the existing voluntary moratorium.

Myth: Cloning can cure diseases in livestock.

Cloning can’t directly cure diseases in livestock, but the cloning process may be one way to make a healthy copy of a valuable animal that has contracted a disease, been injured, or died. In addition, cloning may also be a way to duplicate a disease-resistant animal, and over generations create a disease-resistant herd.

Myth: Scientists can bring back extinct species by cloning them.

Although it’s theoretically possible, at this time it’s not very likely to happen. There are multiple technical barriers to doing this. First, because of the relatively low success rate of cloning, you’d need hundreds to thousands of cells from the extinct animal. Further, those cells would have to have DNA that hadn’t degraded since the animals were last alive. Then you’d have to find a very, very closely related species to provide the egg cell whose nucleus would be removed. After that, you’d have to implant any dividing embryos into the “normal” development environment (You might be able to use an elephant to act as a surrogate dam for a wooly mammoth, but there is no modern animal comparable to a dinosaur.) Then, you’d have to hope that the surrogate dam didn’t reject the embryo as “too foreign.” So although it’s possible, we wouldn’t expect that you’d see this at this time or in the near future.

Well, okay, but how about cloning endangered species?

That’s not only possible, but it’s been done in some limited cases. Scientists have cloned sheep from very small populations, members of rare cattle breeds, and the gaur and banteng, two species closely related to domesticated cattle species.

More information from FDA on Cloning.

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Harry and David Issues Nationwide Recall On Harry and David Giant Cashews

Harry and David Issues Nationwide Allergy Alert on Undeclared Peanuts and Other Nuts in Harry and David Giant Cashews

Contact:
Mr. Bill Ihle
541-864-2145 (Media Calls Only)

FOR IMMEDIATE RELEASE -- January 22, 2008 -- Harry and David, of Medford, Oregon, is voluntarily recalling approximately 2130 boxes of 4 oz. Harry & David Giant Cashews because they may contain mixed nuts, including peanuts, almonds, pecans and Brazil nuts not declared on the ingredient statement. People who have an allergy or severe sensitivity to these ingredients (peanuts, almonds, pecans and/or Brazil nuts) run the risk of serious or life-threatening allergic reaction if they consume these products.

The affected product was distributed throughout the United States only through Harry and David Stores beginning 11/16/07.

Harry and David is recalling all 4 oz. boxes of Giant Cashews with lot codes 2507 MSL 15:00 through 2507 MSL 18:00 and a use by date of 6/28/08. The lot code and use by date are ink jetted on the bottom of the box. Affected boxes also can be recognized by the price sticker on the bottom, or lower portion of the back, of the box. The price sticker states "Nuts Mixed Nuts Box 4oz". These products are packaged in 4 oz. paperboard boxes with bags of metalized film containing nuts inside. The boxes are olive green with a pale green design in the background.

There have been no illnesses or injuries reported to date. Anyone concerned about an illness/injury should contact a physician immediately.

This problem occurred during a product changeover when packaging for cashews was comingled with packaging for the mixed nuts.

Consumers with product may return it to the any Harry and David retail store for a full refund. Consumers with questions about the recalled product may phone the Harry and David Customer Service division at 800-233-1101, 24 hours a day.


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Deli Chef Tri-Bean Salad Recalled From Some Kroger Stores

Deli Chef Tri-Bean Salad Recalled From Some Kroger Stores

Contact:
Meghan Glynn
(513) 762-1304

FOR IMMEDIATE RELEASE -- Cincinnati, Ohio, January 21, 2008 – Inter-American Products, a division of The Kroger Co. (NYSE: KR), today announced a voluntary recall on all codes of Deli Chef Tri-Bean Salad sold from store deli counters in some states because the product has the potential to be contaminated with Clostridium botulinum, a bacterium which can cause a potentially life threatening condition called botulism. Consumers should not consume this product even if it does not look or smell spoiled.

The Tri-Bean Salad was sold at deli counters in stores in Colorado, Illinois, Indiana, Kansas, Kentucky, Michigan, Missouri, Nebraska, Ohio, New Mexico, Utah, Washington, West Virginia, and Wyoming.

The green beans in the Tri-Bean Salad were processed by the New Era Canning Company, which has announced a recall of the beans. The text of the New Era Canning Company Recall can be found on the FDA website and our previous post.

No illnesses have been reported. No other salad products are affected by this recall.

Customers are encouraged to dispose of the product and should contact the store where the product was purchased to receive a refund.

Consumers with questions or concerns may call Inter-American Products at 1-800-697-2448.


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B. Braun Medical Inc. Recalls All Lots and All Sizes of Pre-Filled Heparin and Normal Saline Flush Syringes

B. Braun's Supplier Prompts Voluntary Recall of All Lots and All Sizes of Pre-Filled Heparin and Normal Saline Flush Syringes
AM2PAT Inc. manufactures these pre-filled syringes under both its private label, Sierra Pre-Filled Inc., as well as under the B. Braun Medical Inc. label

Contact:
Stephanie Euler, 908-276-4344 ext. 213
Susan Denby, 610-997-4856

FOR IMMEDIATE RELEASE -- January 18, 2008 -- B. Braun Medical Inc. was recently notified by its contract manufacturer, AM2PAT Inc., of a nationwide recall of all lots and sizes of Pre-filled Heparin and Saline Flush Syringes.

Catalog #

Lot #

Description

513584

All

Normal Saline 3mL in 12 mL Syringe

513586

All

Normal Saline 5mL in 12 mL Syringe

513587

All

Normal Saline 10mL in 12 mL Syringe

513610

All

10 units/mL Heparin, 5mL in 12 mL Syringe

513611

All

100 units/mL Heparin, 3mL in 12 mL Syringe

513612

All

100 units/mL Heparin, 5mL in 12 mL Syringe

Customers that have the recalled product in their possession should discontinue use immediately. If patients report any problems that may be related to usage of this product a physician should be contacted. Customers may contact the B. Braun Medical Inc. Customer Support Department at (800) 227-2862, Monday through Friday, 8 AM to 7 PM EST for instructions for handling the affected product and to arrange for replacement product.

Based on ongoing FDA inspection of AM2PAT Inc.'s facility, and CDC investigation it has been determined that there is a potential for the sterility of these affected products to be compromised, which may result in potential contamination. AM2PAT previously initiated a recall of one lot of Sierra Pre-Filled Heparin (lot #070926H) that was found to be contaminated with Serratia marcescens, which may lead to patient infections. CDC has confirmed growth of Serratia marcescens from several unopened syringes of this product in this specific AM2PAT lot. This type of bacterial infection could present a serious adverse health consequence that could lead to life-threatening injuries and/or death.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

  • Online: www.fda.gov/medwatch/report.htm
  • Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
  • Fax: 1-800-FDA-0178

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AM2 PAT, Inc. Issues Nationwide Recall of All Lots and All Sizes of Pre-Filled Heparin and Normal Saline Flushes

NATIONWIDE URGENT DEVICE RECALL
RECALL EXPANSION 2nd Notice

FOR IMMEDIATE RELEASE DATE 01/18/08

AM2PAT, INC. (doing business as Sierra Pre-Filled Inc)
455 W. DEPOT STREET
ANGIER, NC 27501
919-552-9689

AM2 PAT, Inc. Issues Nationwide Recall of All Lots and All Sizes of Pre-Filled Heparin and Normal Saline Flushes

AM2 PAT, Inc., Angier, North Carolina, is initiating a Nationwide recall of all lots of both Heparin and Saline pre-filled flushes manufactured by AM2 PAT. These products are distributed under two brand names, Sierra Pre-Filled Inc. and B. Braun. These products are sold in 3ml, 5ml sizes for Heparin and 3ml, 5ml and 10ml sizes for Normal Saline. Both products are sold as pre-filled syringes.

One lot under recall of this product 1003-02, Lot 070926H, Heparin IV flush syringes has been found to be contaminated with Serratia marcescens, which has resulted in patient infections. CDC has confirmed growth of Serratia marcescens from several unopened syringes of this product.

This type of bacterial infection could present a serious adverse health consequence that could lead to life-threatening injuries and/or death.

Consumers and user facilities who have any of these recalled pre-filled syringes, Heparin or Saline Lock Flush Solution USP, should stop using the product immediately. These products should be immediately quarantined in your inventory and returned to your distributor immediately.

The following information for this recall includes:

MANUFACTURER: Sierra Pre-Filled, Inc., Angier, North Carolina

PRODUCT DESCRIPTION: Heparin Lock Flush Solution USP, All Strengths and Sizes

Saline Lock Flush Solution USP, All Strengths and Sizes

LOT # NDC # CATALOG # Product Brand Name
All 64054-1003-02 1003-02 Heparin Lock Flush 100units/ml 5ml

64054-1003-01 1003-01 Heparin Lock Flush 100units/ml 3ml

64054-3005-02 3005-02 Heparin Lock Flush 10units/ml 5ml

64054-3003-02 3003-02 Heparin Lock Flush 10units/ml 3ml

64054-3003-06 3003-06 Heparin Lock Flush 10units/mL 3ml (6ml syringe)

64054-3005-06 3005-06 Heparin Lock Flush 10units/mL 5ml (6ml syringe)

64054-0910-2 0910-12 Normal Saline Flush 10ml

64054-0905-2 0905-12 Normal Saline Flush 5ml

64054-0903-2 0903-12 Normal Saline Flush 3ml

The firm voluntarily recalled these products after confirming bacterial contamination in some end user samples of product code 1003-02, Lot 070926H.

These products have been distributed nationwide.

It appears from an ongoing Food and Drug Administration (FDA) inspection of AM2 PAT, Inc.’s facility that the firm is not in compliance with the Quality System regulation and failed to have adequate controls to ensure necessary sterility of its pre-filled syringes.

Consumers with questions may contact Sierra Pre-Filled at 919-552-9689, Monday through Friday, 10am-5pm Eastern Standard Time.

This recall is being conducted with the knowledge of the Food and Drug Administration.

Any adverse reactions experienced with the use of this product, and/or quality problems should also 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.


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Nordstrom Recalls Taper and Votive Candles Due To Fire Hazard

FOR IMMEDIATE RELEASE
January 22, 2008
Release #08-170

Firm’s Recall Hotline: (800) 804-0806
CPSC Recall Hotline: (800) 638-2772
CPSC Media Contact: (301) 504-7908
Nordstrom Media Contact: (206) 373-3038


Nordstrom Recalls Taper and Votive Candles Due To Fire 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.

Name of Product: Nordstrom “At Home” Taper and Votive Candles

Units: About 2,500

Importer: Nordstrom Inc., of Seattle, Wash.

Hazard: The candle's exterior coating can ignite, posing a fire hazard.

Incidents/Injuries: Nordstrom has received four reports of flames or smoke coming from the candle or the exterior coating. One instance of property damage was reported but no injuries have been reported.

Description: This recall involves Nordstrom “At Home” 10-inch taper candles and Nordstrom “At Home” votive candles. The taper candles were sold under style numbers NR-07059G and NR-07059S. The votive candles were sold under style numbers NR-07001G and NR-07001S. The candles came in silver and gold and were sold in a box of six. The style number can be found on a sticker at the bottom of the packaging.

Manufactured in: Taiwan

Sold at: Nordstrom stores nationwide from September 2007 through December 2007 for about $18 for the taper candles and about $12 for the votive candles.

Remedy: Consumers should stop using these candles immediately and return them to any Nordstrom store for a full refund.

Consumer Contact: For additional information, contact Nordstrom at (800) 804-0806, 24 hours per day, visit the company’s Web site at www.nordstrom.com, or email contact@nordstrom.com

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Tuesday, January 22, 2008

CoGenesys Inc. Acquired By Teva Pharmaceutical Industries Ltd.

Generic-drug giant Teva Pharmaceutical Industries Ltd. has agreed to acquire biopharmaceutical company CoGenesys Inc. for $400 million in cash, Teva announced Tuesday.

The deal, which is expected to close during the first half of 2008, is likely to stoke the debate about the role generic-drug makers should play in the emerging market for biological therapies.

CoGenesys Inc., a closely held spinoff of Human Genome Sciences Inc., would give Jerusalem-based Teva a foothold in the market for biologic therapies.

News Source,

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Stamina Products to Pay $105,000 Civil Penalty for Failure to Report Defects with Mini-Trampolines

FOR IMMEDIATE RELEASE
January 22, 2008
Release #08-171
CPSC Hotline: (800) 638-2772
CPSC Media Contact: (301) 504-7908

Stamina Products to Pay $105,000 Civil Penalty for Failure to Report Defects with Mini-Trampolines

WASHINGTON, D.C. - The U.S. Consumer Product Safety Commission (CPSC) announced today that a Missouri-based manufacturer of trampolines has agreed to pay the government a $105,000 civil penalty. The penalty settles allegations that Stamina Products, of Springfield, Mo., failed to report in a timely manner injuries from defective mini-trampolines. In April 2006, CPSC and Stamina Products announced the recall of about 668,000 mini-trampolines.

Between April 2002 and June 2005, Stamina Products received eight reports from consumers who alleged that the trampoline sprang back during the folding/unfolding process causing facial lacerations that required stitches, broken teeth, bruises, headaches, neck pain, broken facial bones, loss of mouth sensation, and blurred vision. Stamina Products failed to report these incidents to the CPSC in a timely manner. CPSC was finally informed of the incidents in July 2005.

Federal law requires firms to report to CPSC within 24 hours after obtaining information that a product contains a defect which could create a substantial product hazard, or creates an unreasonable risk of serious injury or death.

In agreeing to settle the matter, Stamina Products denies that it violated federal law.

Stamina Products to Pay $105,000 Civil Penalty for Failure to Report Defects with Mini-Trampolines
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