Products found to contain undeclared medicines
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| The United States: Bella Vi Brand Products by Pure Edge Nutrition: Recall - Undeclared Drug Ingredients Sibutramine or A Combination of Both Sibutramine and Phenolphthalein |
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The US Food and Drug Administration (FDA) announced that Pure Edge Nutrition, LLC is voluntarily recalling one lot of each: Bella Vi Insane Bee Pollen Capsules (lot # 201303), Bella Vi BTrim Ultimate Boost (lot # BTRM3452), Bella Vi BTrim Max (lot # BTX13), Bella Vi Extreme Accelerator (lot # BTRX7654), Bella Vi Insane Amp’d (lot # VINA2013), and two lots of Bella Vi Amp’d Up (lot # AU2013AB and BVAU813), to the consumer level.
FDA laboratory analyses found the products to contain undeclared sibutramine or a combination of both sibutramine and phenolphthalein. Sibutramine was removed from the US market in October 2010 for safety reasons and phenophthalein is used as a laxative and not approved for marketing in the US. Therefore, these products are unapproved new drugs. Products containing sibutramine and phenophthalein pose a threat to consumers because sibutramine can increase blood pressure and/or pulse rate in some patients and may present a risk for those with a history of coronary artery disease, congestive heart failure, arrhymias or stroke. These products may also interact in life threatening ways with other medications a consumer may be taking.
All affected products are marketed as dietary supplements for weight loss. 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.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/MedWatch/../ucm390748.htm
In Hong Kong, the above products are not registered pharmaceutical products.
Ends/ Thursday, March 27, 2014
Issued at HKT 15:00
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