On January 13, 2020, the FDA issued a warning letter to Wave Miami, LLC because the company's weight loss supplement, Lipro Dietary Capsule was found to contain the prescription medication tadalafil.
Tadalafil, the active ingredient in Cialis, is prescribed for erectile dysfunction. This drug can cause symptoms like headache and flushing, and can interact with medications containing nitrates such as nitroglycerine, resulting in dangerously low blood pressure.
The FDA warned consumers not to buy or use Lipro in July 2019 after testing by the agency found it to contain tadalafil. According to the FDA's warning letter to Wave Miami, the company not issued a recall of the product.
The letter also states that Lipro is promoted with drug claims, including statements such as "Best Diet Pill for rapid weight loss," and "Lipro diet pills come with a high promise of effective weight lose [sic]. They promise that the user will lose up to 30 pounds in a span of 30 days."
The company has 15 days to notify the FDA of any corrective actions it has taken to address these violations, and was advised by the agency that "Failure to promptly correct these violations may result in legal action without further notice including, without limitation, seizure and injunction.
For other Recalls and Warnings click HERE.For information about reporting serious reactions and problems with medical products to the U.S. Food and Drug Administration through its MedWatch reporting program, please go to http://www.fda.gov/medwatch/how.htm.
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