Posts Tagged ‘Warning’

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KTM Off-Road Motorcycle Recall

Tuesday, February 2nd, 2010

KTM, maker of the defective off road motorcycle, conducted a voluntarily RECALL OF THE 2009 OFF ROAD MOTORCYCLES, in cooperation with The Consumer Product and Safety Commission. The recall was initiated because of the undue risk for injury or death from the motorcycle’s front fork failure. Consumers are advised to immediately stop using the off road motorcycle.

The KTM recall involves approximately 550 2009 Off Road Motorcycle models in orange and black, including: 125SX, 150SX, 250XC-W, and 300XC-W. The defective models were manufactured in Austria and sold in the U.S. from December of 2008 through April 2009. The hazard that has been identified is associated with the front fork inner tube. The front fork inner tube may crack and dislodge from the fork axle. The breakage of the inner tube poses a risk of injury or death to the driver or people surrounding the driver at the time of the breakage. The off road motorcycle costs between $6000. and $8000. Consumers are advised to immediately stop using the off road motorcycle, contact KTM at (888) 985-6090 for a free repair, or visit the KTM North America Inc., of Amherst, Ohio website.

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Posted in Auto Accidents, Consumer Awareness, Lawbits, Off Road Motorcycle Lawsuit, Personal Injury Lawsuit, Pharmaceutical Lawsuits, Product Liability Lawsuit, Recall | No Comments »

Recall: Toll House Cookie Dough

Friday, January 22nd, 2010

Contaminated Toll House cookie dough has been recalled because it was found to be laced with bacteria known as E. coli

Since March 2009, there have been personal injuries reported to the FDA Toll House’s refrigerated cookie dough across 28 states, including: 66 people with illnesses, 25 people hospitalized and 7 people inflicted with Hemolytic Uremic Syndrome, signified by hemolytic anemia and acute renal failure.

Cookie Dough Symptoms for Alarm:
Diarrhea, bloody or otherwise abnormal stools
Stomach cramps
Vomiting
Fever
High blood pressure
Seizures
Paralysis
Blindness

Warning: Protect from Harm
People who have the cookie dough in the refrigerator should throw it away immediately and cleanse surfaces that have come in contact with the cookie dough. It is advised not to touch the cookie dough as this can spread the disease.

Public Action
Lawsuits against Toll House have not been filed to date. The extent of injury has not been evaluated because Hemolytic Uremic Syndrome can become progressively worse over time. Many people recover within a week. However, some people are at high risk for long term debilitating injury. No one that is known to have suffered from Toll House Cookies has died to date.

Nestle has voluntarily recalled all varieties of prepackaged, refrigerated Toll House cookie dough because it has not been narrowed to a specific product at this time. The FDA is conducting an ongoing investigation. The CDC is conducting an ongoing study.

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Safety Warning on Certain Body building Products (October 2009)

Thursday, October 15th, 2009

Video originally created by FDA -- posted by Lawsuit.com on October 6, 2009

FDA is warning the public not to use body-building products that claim to contain steroids or steroid-like substances, because they can cause serious health problems. These products, which are sold online and in retail stores, are promoted as alternatives to anabolic steroids for increasing muscle mass and improving sports performance. Although these products are often marketed as dietary supplements, they are actually unapproved new drugs containing synthetic steroids or steroid-like substances that have not been reviewed for safety and effectiveness by the FDA.

FDA has received reports of serious injuries associated with these products, including liver damage, stroke, kidney failure and pulmonary embolism. It is also known that products containing anabolic steroids can cause a variety of long-term effects, including shrinkage of the testes, infertility and breast enlargement in men, masculinization in women, and short stature in children. They can also produce adverse effects on blood lipids, with increased risk of heart attack and stroke.

FDA has sent a warning letter to American Cellular Laboratories, a company that has marketed these body-building products under a number of brand names. A list of these products can be found below. FDA is also gathering additional information about other products that claim to contain steroids or steroid-like substances.

FDA recommends that healthcare professionals ask patients about their use of any over-the-counter products, including supplements, and that they be alert to patients presenting with the warning signs of steroid use.

Consumers should immediately stop taking any product that claims to contain steroids or steroid-like substances, or to have hormone-like effects in the body. They should seek medical attention if they experience symptoms that might be associated with these products, including nausea, weakness, fatigue, fever, abdominal or chest pain, shortness of breath, jaundice, or discolored urine.

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FDA Scrutiny for Ibuprofen Topical Agent Distribution

Monday, September 21st, 2009

It is illegal for companies to sell over-the-counter topical products that contain active   pharmaceutical agents. Perhaps, this is because active pharmaceutical agents may be linked to serious side effects when at certain concentration levels or in combination with other drugs. Fro example, Ibuprofen is linked to some serious side effects including, Steven’s Johnson Syndrome that leads to partial or total body skin sloughing and blisters resulting in ultimate in death under certain circumstances. Though, the risk of Steven’s Johnson syndrome is very low, it is because of risks like this that the FDA is apt to screen over-the-counter drugs, but regulates only with active pharmaceutical agents are discovered.

The topical Ibuprofen manufactured by some leading companies has been found to contain undeclared active pharmaceutical agents. Any time that active pharmaceutical agents are combined, there is a risk that the combination will produce an adverse reaction. Secondly, anytime an active pharmaceutical agent is contained in an over -the-counter medication, the medication falls under FDA regulation for the evaluation of the safety and efficacy of the drug. It is for this reason that warning letters have been sent to the manufacturers of topical Ibuprofen.

The eight companies that were identified by the FDA to fall under the FDA approval process include:

Emuprofen (Progressive Emu, Inc.)
BioEntopic 15% Ibuprofen Crème (BioCentric Laboratories, Inc.)
Ibunex Topical Ibuprofen (Core Products International, Inc.)
LoPain AF 15% Ibuprofen Crème (Geromatrix Health Products)
IB-RELIEF (MEKT LLC)
Profen HP (Ridge Medical Products)
IbuPRO-10 Plus (Meditrend, Inc. dba Progena Professional Formulations)

IBU-RELIEF 12 (Wonder Laboratories)

These companies’ claims of safety have not been formally reviewed by the FDA.

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Intelence HIV Users and SJS Lawsuits

Friday, September 11th, 2009

Risk of Steven’s Johnson Syndrome Uncovered

Intelence, manufactured by Tibotec Therapeutics, is a drug for people with HIV that has now been found to be associated with Steven’s Johnson Syndrome, a rare life threatening blistering and skin death condition, as well as erythema multiforme and toxic epidermal necrolysis (an advanced SJS condition).  Tibotec Therapeutics, a subsidiary of Johnson and Johnson, together with the Food and Drug Administration joined forces to alert infectious disease physicians so that they may be able to better educate candidates for Intelence. There will be a text change to the warning label of the Intelence bottle to alert consumers of the latest side effect as well.

Since January of 2008 when Intelence was first introduced to the market, there have been two reports of severe reaction and one death following use. Of the two suffering serious injury, one has seriously suffered from SJS and the other, SJS and liver failure. People using Intelence at this time may not be fully ware of the risks. People who are having any type of skin reaction during the use of Intelence should contact their physician immediately and inquire about changing medications.

Steven’s Johnson Syndrome can be a highly debilitating condition that affects people in varying degrees. In some cases, people experience blistering and skin death that progresses over time. People withsevere SJS are often treated in a burn unit to manage skin death which potentially leads to the person’s death when unresponsive to treatment.

At this time, it is not known how many other people will be affected by SJS, erythema multiforme and toxic epidermal necrolysis. Thus, it is unknown if, when or how many lawsuits against Intelence makers will follow.

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