Products found to contain undeclared medicines
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| The United States: Love My Tru Body issues voluntary nationwide recall of Skinny Bee Diet due to presence of undeclared sibutramine, desmethylsibutramine and/phenolphthalein |
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McDonough, Georgia, 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. The product is used as a weight loss dietary supplement and is packaged in white silver bottle with red capsules. To date Love My Tru Body has not received any reports of adverse events related to this recall.
Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010.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. Phenolphthalein 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.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/Recalls/ucm528429.htm
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/ Wednesday, November 09, 2016
Issued at HKT 15:00
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