A new weight loss supplement has been recalledbecause it is tainted with two undeclared ingredients, including one commonly used as a pesticide, according to a U.S. Food and Drug Administration notificationpublished on Aug. 31
Ana Salazar Modela Tu Cuerpo Inc. issued the recall of Lipofit Extreme Fat Burner 2.0 following the FDA’s determination that the daytime (AM) tablets contained fluoxetine and the nighttime (PM) tablets had 2,4-dinitrophenol (DNP), which is used as a pesticide and herbicide, the FDA reported
Both ingredients were undeclared in the affected product, which has an expiration date of September 2027
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Fluoxetine is an FDA-approved active ingredient used targeted for the treatment of depression, obsessive-compulsive disorder and bulimia. However, dinitrophenol is a toxic substance illegally marketed as a weight-loss product and not approved for use by the FDA
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The combination of both ingredients can lead to serious and potentially life-threatening health effects, including heart problems and cardiac arrest, the FDA said in its report
The recallwas prompted after laboratory analysis by the FDA determined the undeclared presence of the substances in the Lipofit Extreme Fat Burner 2.0
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The FDA report states that Lipofit Extreme Fat Burner 2.0 is an unapproved new drug marketed as a weight loss supplement and for which “safety and efficacy have not been established and, therefore, subject to recall.”
The supplement was distributed in the U.S. to individual consumers and through online platforms
Ana Salazar Modela Tu Cuerpo Inc. stopped all distribution and promotion of the affected product and has quarantined the remaining inventory, according to the FDA report
The Houston Chronicle has reached out to Ana Salazar Modela Tu Cuerpo Inc
The company urged consumers to stop using the recalled supplement and to keep it away from children and other people. People should not sell or transfer it to anyone else
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Consumers can contact Ana Salazar Modela Tu Cuerpo Inc. at 954-305-1004 or
The recalled product is Lot 25M12F, with an expiration date of 09/2027
