被 发 现 含 有 未 标 示 西 药 的 产 品
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| The United States: S&B Shopper LLC issues voluntary nationwide recall of Imperial Extreme 2000mg due to presence of undeclared sildenafil and tadalafil (English only) |
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The US Food and Drug Administration (FDA) announces that S&B Shopper LLC is voluntarily recalling all lots of Imperial Extreme 2000mg capsules, to the consumer level. FDA analysis has found this product to contain undeclared sildenafil and 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 tadalafil in Imperial Extreme 2000mg capsules makes them 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 Imperial Extreme 2000mg capsules with undeclared sildenafil and 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, S&B Shopper 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/sb-shopper-llc-issues-voluntary-nationwide-recall-imperial-extreme-2000mg-due-presence-undeclared
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Friday, Mar 26, 2021
Issued at HKT 16:00
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