02.14.14
Florida-based MyNicKnaxs, LLC., has recalled its supplement Reduce Weight Fruta Planta because the products contain an undeclared active pharmaceutical ingredient, Phenolphthalein. 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, but the company has voluntarily agreed to work with FDA in order to protect consumers.
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 U.S. 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.
According to the company, MyKnicKnaxs has taken this voluntary action because it is committed to providing accurate information to all customers and is concerned for the health and safety of all users of Reduce Weight Fruta Planta. All lots of the Reduce Weight Fruta Planta products are being recalled.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax (1-800-FDA-0178).
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 U.S. 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.
According to the company, MyKnicKnaxs has taken this voluntary action because it is committed to providing accurate information to all customers and is concerned for the health and safety of all users of Reduce Weight Fruta Planta. All lots of the Reduce Weight Fruta Planta products are being recalled.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax (1-800-FDA-0178).
