被 发 现 含 有 未 标 示 西 药 的 产 品
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| The United States: Natural Dior LLC issues voluntary nationwide recall of Vitafer-L Gold Liquid due to presence of undeclared tadalafil (English only) |
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The United States Food and Drug Administration (FDA) announces that Natural Dior LLC is voluntarily recalling 10 lots of Vitafer-L Gold Liquid (lot number: 7021-2304, 7017-2304, 7040-2305, 10020-2402, 10011-2404, 7695-2307, R6715-2303, 7292-2305, 9669-2403, 10060-2404), a dietary supplement with iron and vitamins, to the consumer level. 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. The product is used as a state indication and is packaged in 16.9 fl oz (1.06 pt) 500 mL bottles in a folding cardboard box.
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. To date, Natural Dior LLC has not received any reports of adverse events related to this recall.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/natural-dior-llc-issues-voluntary-nationwide-recall-vitafer-l-gold-liquid-due-presence-undeclared
In Hong Kong, the above product is not a registered pharmaceutical product. Related news was previously issued by FDA, and was posted on the Drug Office website on 9 Nov 2024.
Ends/Friday, Feb 28, 2025
Issued at HKT 15:45
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