被 发 现 含 有 未 标 示 西 药 的 产 品
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| The United States: Yolo Studio issues voluntary nationwide recall of PremierZEN Extreme 3000, PremierZEN Plus 5000 & Triple SupremeZEN Plus 3500 due to the presence of undeclared tadalafil (English Only) |
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The US Food and Drug Administration (FDA) announces that Yolo Studio is voluntarily recalling all lots of PremierZEN Extreme 3000, PremierZEN Plus 5000 and Triple SupremeZEN Plus 3500 to the consumer level. FDA analysis has found the product to contain undeclared tadalafil. Tadalafil is ingredient known as a phosphodiesterase (PDE-5) inhibitor found in FDA approved products for the treatment of male erectile dysfunction. The presence of tadalafil in PremierZEN Extreme 3000, PremierZEN Plus 5000 and Triple SupremeZEN Plus 3500 makes these unapproved new drugs for which the safety and efficacy have not been established and, therefore subject to recall.
Consumers with underlying medical issues who take PremierZEN Extreme 3000, PremierZEN Plus 5000 and Triple SupremeZEN Plus 3500 with undeclared tadalafil may experience serious health risks. For example, PDE- 5 inhibitors may interact with nitrates found in some prescription drugs (such as nitroglycerin) lowering blood pressure to dangerous levels that may be life-threatening. Consumers with diabetes, high blood pressure, or heart disease often take nitrates. To date, Yolo Studio has not received any reports of adverse events related to this recall.
These tainted products are marketed as dietary supplements for male sexual enhancement and are packaged in cardboard blisters containing one pill per card.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/yolo-studio-issues-voluntary-nationwide-recall-premierzen-extreme-3000-premierzen-plus-5000-triple
In Hong Kong, the above products are not registered pharmaceutical products.
Ends/Wednesday, Apr 7, 2021
Issued at HKT 16:00
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