WASHINGTON, Feb. 26 (UPI) -- Olaax Corp. is recalling its dietary supplement Maxiloss Weight Advanced in the United States because it contains a banned substance, officials say.
The U.S. Food and Drug Administration said its testing found the Maxiloss Weight Advanced product contains Sibutramine -- an appetite suppressant removed from the U.S. market in October 2010 for safety reasons -- making the supplement 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, the FDA said.
Sibutramine has been withdrawn from U.S marketplace and this active drug ingredient is not listed on the label for the Maxiloss products. No illnesses or injuries have been reported to the company to date related to this product, the FDA said.
Olaax Corp. said it cannot guarantee the authenticity of the products in the marketplace and advises any customers in possession of any Maxiloss Weight Advanced, regardless of lot number, to throw it away.
Consumers with questions regarding this recall can contact Olaax Corp. at 1-863-648-9581, Monday through Friday, 9 a.m. to 5:30 p.m., EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking this drug product.