The FDA has announced a recall of the Maxiloss Weight Advanced Softgels as an unapproved new drug. Olaax Corp is conducting a voluntary nationwide recall of the dietary supplement because testing revealed the product contains undeclared Sibutramine—a drug that has been withdrawn from U.S marketplace. Although Sibutramine was a previously approved controlled substance for the treatment of obesity, it was removed from the U.S. market in October 2010 for safety reasons.
Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk to patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.
Maxiloss Weight Advanced is a “slimming” product manufactured and marketed by various vendors and is made available to customers through various outlets and websites. The product comes in the form of capsule and consumers usually take one capsule on a daily basis. According to the label the products are made-up of herbal and natural ingredients that are safe for human body. The active drug ingredient sibutramine is not listed on the label.
The recall includes all authentic Lot numbers and also known to be counterfeit lot numbers of authentic lots. Any packaging types that are different from listed are counterfeit. Any lot numbers not listed are counterfeit and are also part of the recall.
The lawyers at Heygood, Orr & Pearson have made it a career priority to hold drug manufacturers accountable and responsible for their actions. As a result, we have spent years holding drug companies and medical device manufacturers responsible for the injuries and deaths caused by their reckless conduct. We have represented hundreds of people regarding dangerous fentanyl pain patches, defective hip and knee implant devices, Yaz, Actos, Avandia and Accutane—to name just some examples.
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At Heygood, Orr & Pearson, we believe that when a drug company sells a drug or medical device that is dangerous and unsafe, they should be held responsible for the damage. In addition, we have the resources and experience to protect a person’s rights and the rights of their loved ones against irresponsible pharmaceutical companies and medical device manufacturers.
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* Michael Heygood, James Craig Orr, Jr. and Eric Pearson were selected to the Super Lawyers List, a Thomson Reuters publication, for the years 2003 through 2013.