被 发 现 含 有 未 标 示 西 药 的 产 品
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| The United States: Ummzy LLC issues voluntary nationwide recall of Thumbs up 7 Red 70K, Shogun-X 15000mg, and Krazy Night due to the presence of undeclared tadalafil, sildenafil and vardenafil (English only) |
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The US Food and Drug Administration (FDA) announces that Ummzy LLC is voluntarily recalling all lots of Thumbs up 7 Red 70K, Shogun-X 15000mg, and Krazy Night capsules to consumer level. FDA analysis has found the products to contain undeclared tadalafil, sildenafil and vardenafil. Tadalafil, sildenafil and vardenafil are ingredients known as phosphodiesterase (PD-5) inhibitors found in FDA approved products for the treatment of male erectile dysfunction.The presence of tadalafil, sildenafil and vardenafil in Thumbs up 7 Red 70K, Shogun-X 15000mg, and Krazy Night 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 Thumbs up 7 Red 70K, Shogun-X 15000mg, and Krazy Night capsules with undeclared tadalafil, sildenafil and vardenafil 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, Ummzy LLChas 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 blister foil sheets in a box containing 10 capsules.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/ummzy-llc-issues-voluntary-nationwide-recall-thumbs-7-red-70k-shogun-x-15000mg-and-krazy-night-due
In Hong Kong, the above products are not registered pharmaceutical products.
Ends/Thursday, Apr 1, 2021
Issued at HKT 16:00
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