Silver Spring, Maryland–(ENEWSPF)–April 12, 106. 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Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010.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. Super Herbs has not received any reports if adverse events related to this recall.
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 www.mysuperherbs.com.
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 [email protected] 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.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm 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
This voluntary recall is being conducted with the knowledge of the U.S. Food and Drug Administration.