ISSUE: Olaax Corp announced a nationwide recall of the company's dietary supplement sold under the brand name Maxiloss Weight Advanced Softgels to the user level, because FDA testing found the Maxiloss Weight Advanced product to contain Sibutramine. Sibutramine was a previously approved controlled substance for the treatment of obesity that was removed from the U.S. market in October 2010 for safety reasons, making this product an unapproved new drug.
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. Sibutramine has been withdrawn from U.S marketplace. The active drug ingredient is not listed on the label for these products.
The recall includes ALL authentic lot numbers and 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.
BACKGROUND: Maxiloss Weight Advanced Softgels is marketed as a Natural Herb for Weight Loss. The product is packaged in a green or blue box containing 3 X 12 blister packs per box and bears "Batch Number: 001". The product was sold to distributors nationwide, and known-to-be counterfeit versions are sold on various online sites. This product was distributed nationwide in US from January 2011 to November 2012.
RECOMMENDATION: Consumers with questions regarding this recall can contact Olaax Corporation at 1-863-648-9581, Monday through Friday, 9:00 am to 5:30 pm, EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking this drug product.
[02/25/2013 - Press Release - Olaax Corp]