The Body Shot Bar Unapproved Weight Loss Drug
Step 2,a weight-loss supplement sold by The Body Shot Bar, was found to contain unapproved ingredients, according to the U.S. Food and Drug Administraion (FDA). Subsequently, The Body Shot Bar has recalled all lots of Step 2 in order to prevent any continuing consumption of the potentially dangerous ingredidients, Sibutramine and Phenolphthalein.
The FDA provides the following details regarding these unapproved elements:
The Body Shot Bar Unapproved Weight Loss Drug: Sibutramine
Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010. Sibutramine is known to 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.
The Body Shot Bar Unapproved Weight Loss Drug: Phenolphthalein
Phenolphthalein is an ingredient previously used in over-the-counter laxatives, but because of concerns of carcinogenicity, it is not currently approved for marketing in the United States. Health risks associated with phenolphthalein could include potentially serious gastrointestinal disturbances, irregular heartbeat, and cancer with long-term use.
Unapproved Ingredients in Product
These undeclared ingredients make these products unapproved new drugs for which safety and efficacy have not been established. These products may also interact in life-threatening ways with other medications a consumer may be taking.
Details of Body Shot Bar Recall
The product is used as a weight loss dietary supplement and is packaged in a white bottle in blue and gold. The affected lots of Step 2 were distributed March 1- May 6 2016 of Step 2 60 gold capsule (350MG per) capsules to the consumer level and include the following expiration date 7/30/2017. Product was distributed nationwide to consumers via www.thebodyshotbar.com
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