Recalled weight loss products are tainted with toxic substance, FDA says
Recalled weight loss product (FDA)
A product sold for weight loss has been recalled because it contains toxic substances that can cause "a wide range of serious and potentially life-threatening adverse effects."
The recall involves Lipofit Extreme Fat Burner 2.0, made by Ana Salazar Modela Tu Cuerpo Inc.
Weight loss drugs recalled
What we know:
The tainted Lipofit Extreme Fat Burner 2.0 is marketed as a dietary supplement and is packaged as AM and PM tablets. The recalled product is identified as Lot 25M12F, expiration date 09/2027. The product was sold online.
The Food and Drug administration says the weight loss product was found to have undeclared fluoxetine in the daytime pills and undeclared 2,4-Dinitrophenol in the nighttime tablets.
Fluoxetine is an FDA-approved drug used to treat depression and other conditions. Its common brand name is prozac. The FDA says 2,4-Dinitrophenol (DNP) is a toxic substance commonly used as a pesticide, dye, wood preservative and herbicide. It is illegally marketed as a weight-loss product and is not approved by the FDA for any use.
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Lipofit Extreme Fat Burner 2.0 is not an FDA-approved drug.
What we don’t know: It’s unclear how the products were tainted with fluoxetine and DNP.
What they're saying:
"When tainted with both fluoxetine and DNP, Lipofit Extreme 2.0 Fat Burner can cause a wide range of serious and potentially life-threatening adverse effects," the FDA says. "Users may experience 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.
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"Neurological effects including seizures may also occur, along with abnormal bleeding and suicidal thoughts. Long-term exposure carries additional risks, including damage to the eyes, skin, bone marrow, nervous system, and heart, as well as dangerously high body temperature and rapid breathing. When combined with certain other medications, the risk of fatal cardiac events is further elevated."
There are no reports of illness or death linked to the recalled product.
What you can do:
Consumers who have the affected product should stop using it immediately, keep it separated from children and other people, and should not sell or give it to anyone else.
Consumers who purchased the recalled product should contact Ana Salazar Modela Tu Cuerpo Inc. at (954) 305-1004 or yandrydy@gmail.com for further instructions. You can also report any adverse reactions or issues to the FDA's MedWatch Adverse Event Reporting program.
The Source: This report includes information from the Food and Drug Administration.