Three Undeclared Drugs Found in Weight Loss Capsules
Super Herbs announced a voluntary recall of its Super Herbs light green and dark green capsules after FDA laboratory testing found them to contain sibutramine, desmethylsibutramine, and/or phenolphthalein. Super Herbs has been marketed online as a weight loss dietary supplement.
Sibutramine is an appetite suppressant that was pulled from the U.S. market in 2010. Desmethylsibutramine is an active metabolite of sibutramine. Both ingredients substantially raise blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.
Phenolphthalein is no longer marketed in the U.S. due to concerns of carcinogenicity. It was used previously in over-the-counter laxatives.
Inclusion of these undeclared ingredients make Super Herbs capsules an unapproved new drug for which efficacy nor safety have been established. The company has recalled all bottles that have been nationally distributed. The light and dark green 350mg capsules are packaged in 30-count clear bottles.
Customers are being notified by email and Super Herbs are arranging for the return of affected products. Those in possession of the recalled light and dark green capsules should stop using the product. The capsules will be discontinued.
For more information call (305) 204-7668 or visit FDA.gov.