Product Recalled Due to Presence of Undeclared Sibutramine, Desmethylsibutramine and/Phenolphthalein
McDonough, Georgia–(ENEWSPF)–November 8, 2016. Love My Tru Body McDonough, GA is voluntarily recalling all of Skinny Bee Diet 500 mg MFD: 03.07.2106 EXP: 03.06.2018 distributed March 23 – April 28, 2016 to the consumer level after FDA laboratory testing found Skinny Bee Diet to contain sibutramine, desmethylsibutramine, and/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Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010.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. To date Love My Tru Body has not received any reports of adverse events related to this recall.
The product is used as a weight loss dietary supplement and is packaged in white silver bottle with red capsules. The affected Skinny Bee Diet product includes bottles MFD: 03.07.2016 EXP: 03.06.2018 Love My Tru Body distributed Skinny Bee Diet capsules nationwide March 23 – April 28, 2016 to consumers via the internet www.lovemytrubody.com
Love My Tru Body notified its customers by US Mail. Consumers who are currently in possession of recalled Skinny Bee Diet capsules should stop using the product and discard.
Consumers with questions regarding this recall can contact Love My Tru Body by email at [email protected] phone at (800) 540-7315, Monday – Friday 8:00 am to 4:00 pm EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this 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.