The US Food and Drug Administration (FDA) announces that Today The World is voluntarily recalling Sustain herbal dietary supplement capsules and Schwinnng capsules to the consumer level. FDA analysis has found the products to contain undeclared tadalafil and nortadalafil (structurally similar to tadalafil). Tadalafil and nortadalafil are active drug ingredients known for treatment of male erectile dysfunction. The presence of tadalafil and nortadalafil in Sustain capsules and Schwinnng capsules makes them unapproved new drugs for which the safety and efficacy have not been established and, therefore subject to recall.
Consumption of products with undeclared tadalafil or nortadalafil 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, no adverse events have been reported.
These tainted products are marketed as dietary supplements for male sexual enhancement.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/today-world-issues-voluntary-nationwide-recall-all-lots-sustain-and-schwinnng-brand-dietary
In Hong Kong, the above products are not registered pharmaceutical products. Related news was previously issued by FDA, and was posted on the Drug Office website on 27 Dec 2023 and 31 Jan 2024.
Ends/Tuesday, Feb 6, 2024
Issued at HKT 15:00
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