Hydroxycut Recall

Attorney Rob Bunch is investigating these potential claims, and his number is 888-422-2882:

 

Hydroxycut Recall

 

The Recall:

The U.S. Food and Drug Administration is warning consumers to immediately stop using Hydroxycut products by Iovate Health Sciences Inc., of Oakville, Ontario and distributed by Iovate Health Sciences USA Inc. of Blasdell, N.Y. Some Hydroxycut products are associated with a number of serious liver injuries. Iovate has agreed to recall Hydroxycut products from the market.

The FDA has received 23 reports of serious health problems ranging from jaundice and elevated liver enzymes, an indicator of potential liver injury, to liver damage requiring liver transplant. One death due to liver failure has been reported to the FDA. Other health problems reported include seizures; cardiovascular disorders; and rhabdomyolysis, a type of muscle damage that can lead to other serious health problems such as kidney failure.

Liver injury, although rare, was reported by patients at the doses of Hydroxycut recommended on the bottle. Symptoms of liver injury include jaundice (yellowing of the skin or whites of the eyes) and brown urine. Other symptoms include nausea, vomiting, light-colored stools, excessive fatigue, weakness, stomach or abdominal pain, itching, and loss of appetite.

“The FDA urges consumers to discontinue use of Hydroxycut products in order to avoid any undue risk. Adverse events are rare, but exist. Consumers should consult a physician or other health care professional if they are experiencing symptoms possibly associated with these products,” said Linda Katz, M.D., interim chief medical officer of the FDA’s Center for Food Safety and Applied Nutrition.

Hydroxycut products are dietary supplements that are marketed for weight-loss, as fat burners, as energy-enhancers, as low carb diet aids, and for water loss under the Iovate and MuscleTech brand names.  The list of products being recalled by Iovate currently includes:

Hydroxycut Regular Rapid Release Caplets
Hydroxycut Caffeine-Free Rapid Release Caplets
Hydroxycut Hardcore Liquid Caplets
Hydroxycut Max Liquid Caplets
Hydroxycut Regular Drink Packets
Hydroxycut Caffeine-Free Drink Packets
Hydroxycut Hardcore Drink Packets (Ignition Stix)
Hydroxycut Max Drink Packets
Hydroxycut Liquid Shots
Hydroxycut Hardcore RTDs (Ready-to-Drink)
Hydroxycut Max Aqua Shed
Hydroxycut 24
Hydroxycut Carb Control
Hydroxycut Natural

Although the FDA has not received reports of serious liver-related adverse reactions for all Hydroxycut products, Iovate has agreed to recall all the products listed above. Hydroxycut Cleanse and Hoodia products are not affected by the recall. Consumers who have any of the products involved in the recall are advised to stop using them and to return them to the place of purchase. The agency has not yet determined which ingredients, dosages, or other health-related factors may be associated with risks related to these Hydroxycut products. The products contain a variety of ingredients and herbal extracts.

Health care professionals and consumers are encouraged to report serious adverse events (side effects) or product quality problems with the use of these products to the FDA’s MedWatch Adverse Event Reporting program online, by regular mail, fax or phone.
The FDA continues to investigate the potential relationship between Hydroxycut dietary supplements and liver injury or other potentially serious side effects.

FDA News: Healon D Recall

The U.S. Food and Drug Administration announced a Class I recall of lot no. UD30654 of Healon D, an ophthalmic viscosurgical device (OVD) manufactured by Advanced Medical Optics Inc. (AMO) of Santa Ana, Calif. OVDs are viscoelastic materials used to maintain space in the eye during surgery. Typically, OVDs are pre-packaged in a syringe and are applied using a small tube.

 AMO received 66 adverse event reports associated with the recalled products. Tests of this lot revealed elevated levels of endotoxin, which has been associated with post-operative intraocular inflammation and TASS.

TASS is a post-operative, acute inflammation of the anterior segment of the eye (the front third of the eye including the cornea, iris and lens). TASS has been linked to solutions and devices used during eye surgery, such as OVDs, intraocular lenses and irrigation solutions.


Toxic Anterior Segment Syndrome (TASS) is an acute, sterile inflammation following generally uneventful cataract and anterior segment surgery.

One of the main factors in differentiating TASS from an infectious other condition is the rapid onset. Most patients with TASS will develop symptoms within 12 to 24 hours of the surgery. . Patients may show signs of diffuse corneal edema  and they may also show signs of iris atrophy  with pupillary abnormalities and eventual increased intraocular pressure.

 

The degree of damage caused by TASS depends on many factors, including the type and amount of substance introduced into the eye, the duration of exposure, and how quickly treatment begins. An especially acute form of TASS, called toxic endothelial cell destruction syndrome, predominantly affects the corneal endothelium,7 whereas toxic endophthalmitis or sterile endophthalmitis significantly affects the posterior segment.