TOPIC: Lipofit Extreme Fat Burner 2.0 by Ana Salazar Modela Tu Cuerpo: Recall - Due to Presence of Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)
AUDIENCE: Consumer, Patient, Health Care Professional, Pharmacy, Gastroenterology, Cardiology, Neurology
ISSUE: Ana Salazar Modela Tu Cuerpo is recalling Lipofit Extreme Fat Burner 2.0, Lot 25M12F, expiration date 09/2027 because FDA laboratory analysis has found Lipofit Extreme Fat Burner 2.0 to be tainted with undeclared fluoxetine in the daytime (AM) tablets and undeclared 2,4-dinitrophenol (DNP) in the nighttime (PM) tablets. Fluoxetine is an active ingredient in an FDA-approved drug used to treat conditions including depression, bulimia, and obsessive-compulsive disorder. 2,4-Dinitrophenol (DNP) is a toxic substance (commonly used as a pesticide, dye, wood preservative and herbicide) that is illegally marketed as a weight-loss product and is not approved by the FDA for any use. 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, is subject to recall.
Risk Statement: Lipofit Extreme 2.0 Fat Burner, is a product promoted and sold for weight loss. 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. 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. 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.
The recalled product is identified as Lot 25M12F, expiration date 09/2027.
To date, Ana Salazar Modela Tu Cuerpo has not received any known reports of adverse events related to this recall.
For more information about this recall, click on the red button "Read Recall" below.
BACKGROUND: The tainted Lipofit Extreme Fat Burner 2.0 is marketed as a dietary supplement for weight loss.
RECOMMENDATIONS:
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Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.
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Consumers who have the affected product should stop using it immediately, keep it separated from children and other people, and should not sell, give, or transfer it to anyone else.
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Consumers who purchased the recalled product should contact Ana Salazar Modela Tu Cuerpo Inc. at (954) 305-1004 or yandrydy@gmail.com for instructions regarding the disposition of the recalled product.
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Consumers should not mail or dispose of the product until appropriate return or disposition instructions are provided.
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