Reduce Weight Fruta Planta: Recall - Undeclared Drug Ingredient
Audience: Consumer
[Posted 02/14/2014]
ISSUE: MyNicKnaxs, LLC notified the public it is recalling all lots of "Reduce Weight Fruta Planta". FDA lab analysis of the product found Reduce Weight Fruta Planta to contain 10.2 mg of Phenolphthalein. Phenolphthalein was once an ingredient used in over-the-counter laxatives. Due to concerns of carcinogenicity, Phenolphthalein 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.
BACKGROUND: See the Press release for product photos.
RECOMMENDATION: Customers are advised to immediately discontinue use. Consumers with questions should contact mynicknaxs at 386-337-8142 or via e-mail at nicnaxs@yahoo.com Monday - Friday, 2pm - 7:00 pm, EDT
[02/14/2014 - Press Release - MyNicKnaxs, LLC]
[02/14/2014 - Product Photos - MyNicKnaxs, LLC]
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