Super Herbs Capsules: Recall - Undeclared Drug Ingredients

[Posted 04/12/2016]

AUDIENCE: Consumer

ISSUE: Super Herbs is voluntarily recalling all bottles of SUPER HERBS, light green and dark green capsules to the consumer level after FDA laboratory testing found SUPER HERBS to contain sibutramine, desmethylsibutramine, and/or phenolphthalein.

Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010. Desmethylsibutramine is an active metabolite of sibutramine. Sibutramine and its active metabolites substantially increase 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. Phenolpthalein was previously used in over-the-counter laxatives, but because of concerns of carcinogenicity, it is no longer marketed in the U.S.

These undeclared ingredients make this product an unapproved new drug for which safety and efficacy have not been established.

BACKGROUND: The product is used as a weight loss dietary supplement and is packaged in clear bottle with light green and dark green capsules. The affected Super Herbs product includes all bottles which have been distributed nationwide to consumers via internet mysuperherbs.com. See the press release for product photos.

RECOMMENDATION: Super Herbs is notifying its customers by Email and is arranging for return. Consumers who are currently in possession of recalled Super Herbs light green and dark green capsules should stop using the product and contact Super Herbs. SUPER HERBS will be discontinued.

Consumers with questions regarding this recall can contact Super Herbs by email at superherbs101@gmail.com or by phone at (305) 204-7668, Monday - Friday. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[04/11/2016 - Press Release - Super Herbs]