Products found to contain undeclared medicines
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| The United States: MyNicKnaxs, LLC. Issues a Voluntary Nationwide and International Recall of All Weight Loss Formulas of Reduce Weight Fruta Planta due to Undeclared Ingredient Phenolphthalein |
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FDA announced that MyNicKnaxs, LLC., located in Florida is announcing a recall of Reduce Weight Fruta Planta because the products contain an undeclared active pharmaceutical ingredient: Phenolphthalein. The FDA lab analysis of the product found Reduce Weight Fruta Planta to contain 10.2 mg of Phenolphthalein. No illnesses or injuries have been reported to MyKnicKnaxs, LLC., in connection with these products.
Phenolphthalein was once an ingredient used in over-the-counter laxatives, but because of concerns of carcinogenicity is not currently approved for marketing in the United States. This undeclared ingredient makes Reduce Weight Fruta Planta an unapproved new drug for which safety and efficacy have not been established. Consumption of this product could include potentially serious gastrointestinal disturbances, irregular heartbeat, and cancer with long-term use. All lots of the Reduce Weight Fruta Planta products are being recalled.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/Recalls/ucm385919.htm
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/ Friday, February 14, 2014
Issued at HKT 15:00
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