TOPIC: Vitafer-L Gold Liquid by Natural Dior: Recall - Due to Presence of Undeclared Tadalafil
AUDIENCE: Consumer, Health Care Professional, Pharmacy
ISSUE: Natural Dior LLC is recalling the affected lots of Vitafer-L Gold Liquid, a dietary supplement with iron and vitamins because the product has been found to contain undeclared tadalafil, an ingredient in FDA approved products for treatment of male erectile dysfunction in the family of drugs known as phosphodiesterase (PDE-5) inhibitors. Products containing tadalafil cannot be marketed as dietary supplements. Vitafer-L Gold Liquid is an unapproved new drug for which safety and efficacy have not been established and, therefore, subject to recall.
Risk Statement: Consumption of products with undeclared tadalafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may cause a significant drop in blood pressure that may be life threatening. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Among the adult male population, who are most likely to use this product, adult males who use nitrates for cardiac conditions are most at risk.
The product was sold nationwide via Amazon and Walmart and distributed through wholesale accounts. The product was also exported to Miami, Florida, through an importer (Laboratorio Natural Dior LLC).
To date, Natural Dior LLC has not received any reports of adverse events related to this recall.
For more information about this recall, click on the red button "Read Recall" below.
BACKGROUND: The product being recalled is sold as a dietary supplement for male enhancement.
RECOMMENDATIONS:
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Consumers should contact their physician or health care provider if they have experienced any problems that may be related to taking or using this product.
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Consumers who have purchased this product should stop using it immediately and dispose of it properly or return it to the place of purchase for a refund.
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Consumers with questions regarding this recall can contact Natural Dior LLC at +57 315 2814091 or via email at vitafer.original@gmail.com.
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