FDA Analysis Prompts Recall of Several Weight Loss Products
New Life Nutritional Center, New York, NY, is recalling all lots of “Super Fat Burner capsules, Maxi Gold capsules and Esmeralda softgels” to the user level after FDA analysis revealed the products contain undeclared active pharmaceutical ingredients: sibutramine, phenolphthalein or a combination of both sibutramine and phenolphthalein.
Similarly, Toms River, NJ-based Pure Edge Nutrition, LLC is voluntarily recalling one lot of each: Bella Vi Insane Bee Pollen Capsules, Bella Vi BTrim Ultimate Boost, Bella Vi BTrim Max, Bella Vi Extreme Accelerator, Bella Vi Insane Amp’d, and two lots of Bella Vi Amp’d Up to the consumer level. The products were also found to contain undeclared sibutramine or a combination of both sibutramine and phenolphthalein through FDA laboratory analyses.
Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010 due to increased risk of seizures, heart attacks, arrhythmia and strokes.
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 U.S. These undeclared ingredients make these products unapproved new drugs for which safety and efficacy have not been established.
At this time no illnesses or injuries have been reported to New Life Nutritional Center or Pure Edge Nutrition in connection with these products.
New Life Nutritional Center’s products are used as weight loss aids and are packaged in 30 capsule bottles. All lots of these products are being recalled.
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