被 發 現 含 有 未 標 示 西 藥 的 產 品
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| The United States: QMART issues voluntary nationwide recall of IMPERIAL Gold 2000, PremierZEN Extreme 3000, BURRO en PRIMAVERA 60000 & IMPERIAL Platinum 2000 due to presence of undeclared sildenafil and/or tadalafil (English Only) |
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The US Food and Drug Administration (FDA) announces that QMART is voluntarily recalling all lots of IMPERIAL Gold 2000, PremierZEN Extreme 3000, BURRO en PRIMAVERA 60000 and IMPERIAL Platinum 2000 to the consumer level. FDA analysis has found the products to be tainted with undeclared sildenafil and/or tadalafil. Sildenafil and tadalafil are ingredients known as phosphodiesterase (PDE-5) inhibitors found in FDA approved products for the treatment of male erectile dysfunction. The presence of sildenafil and/or tadalafil in IMPERIAL Gold 2000, PremierZEN Extreme 3000, BURRO en PRIMAVERA 60000 and IMPERIAL Platinum 2000 renders them unapproved drugs for which the safety and efficacy have not been established and, therefore, subject to recall.
Consumers with underlying medical issues who take IMPERIAL Gold 2000, PremierZEN Extreme 3000, BURRO en PRIMAVERA 60000 and IMPERIAL Platinum 2000 capsules with undeclared sildenafil and/or 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, QMART has not received any reports of adverse events related to this recall.
These tainted products are marketed as dietary supplements for male sexual performance enhancement and are packaged in cardboard blisters.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/qmart-issues-voluntary-nationwide-recall-imperial-gold-2000-premierzen-extreme-3000-burro-en
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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