A weight loss supplement has been recalled over two undeclared ingredients, including a toxic substance commonly used as a pesticide and herbicide.
Florida-based Ana Salazar Modela Tu Cuerpo Inc. issued a nationwide recall for Lipofit Extreme Fat Burner 2.0. Affected products have a lot number of 25M12F and an expiration date of September 2027.
The recall was initiated after an analysis by the Food and Drug Administration revealed the supplement was “tainted with undeclared fluoxetine in the daytime (AM) tablets and undeclared 2,4-dinitrophenol (DNP) in the nighttime (PM) tablets.”
The FDA urged consumers in June not to purchase the supplements over the presence of the fluoxetine and DNP.
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Fluoxetine has been used in FDA-approved drugs to treat various conditions, including depression, obsessive-compulsive disorder, and bulimia.
But 2,4-Dinitrophenol (DNP) is a “toxic substance” that is illegally marketed as a weight-loss product and is not approved by the FDA for any use. It is commonly used as a pesticide, dye, wood preservative and herbicide.
“Products containing fluoxetine and DNP cannot be marketed as dietary supplements. Lipofit Extreme Fat Burner 2.0 is an unapproved new drug for which safety and efficacy have not been established and, therefore, subject to recall,” the company announcement reads.
A 2011 review by U.K. medical researchers found that DNP can lead to rapid weight loss, but can also cause adverse effects, including death.
Reports of deaths and blindness linked to DNP in the 1930s helped prompt stronger federal regulation of drugs. The FDA has described DNP as extremely dangerous and not fit for human consumption.
Lipofit Extreme Fat Burner 2.0 could cause a person to experience potentially life-threatening symptoms, including nausea, vomiting, sweating, dizziness and headaches, as well as dangerous heart rhythm problems, rapid heart rate and cardiac arrest, which can result in sudden death, the company announcement reads.
Seizures, abnormal bleeding and suicidal thoughts are also possible, the announcement reads, adding that long-term damage could impact the eyes, skin, bone marrow, nervous system and heart. It could also cause dangerously high body temperature and rapid breathing.
The risk of fatal heart events may increase if the supplement is taken with certain other medications.
Ana Salazar Modela Tu Cuerpo Inc. has not received any reports of adverse events in connection with the recall. Consumers should contact a healthcare provider if they have experienced any symptoms that may be related to the affected product.
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The tainted Lipofit Extreme Fat Burner 2.0, which was packaged as AM and PM tablets, was distributed across the country directly to consumers through online sales.
Consumers who have the recalled product are instructed to stop using it immediately and to keep it away from children and other people.
Anyone who purchased the product should contact Ana Salazar Modela Tu Cuerpo Inc. for instructions on how to dispose of it. Consumers should not mail or dispose of the product until appropriate return or disposition instructions are provided.
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