被 发 现 含 有 未 标 示 西 药 的 产 品
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| The United States: Bit & Bet LLC issues voluntary nationwide recall of Thumbs Up 7 Blue 69K due to presence of undeclared sildenafil and tadalafil (English only) |
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The US Food and Drug Administration (FDA) announces that Bit & Bet LLC is voluntarily recalling all lots of Thumbs Up 7 Blue 69K capsules to consumer level. FDA analysis has found the 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 Thumbs Up 7 Blue 69K capsules make 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 Blue 69K 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, Bit & Bet has not received any reports of adverse events related to this recall.
This tainted product is marketed as a dietary supplement for male sexual enhancement and is packaged in blister foil sheets in a box. Each box contains 10 capsules.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bit-bet-llc-issues-voluntary-nationwide-recall-thumbs-7-blue-69k-due-presence-undeclared-sildenafil
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Wednesday, Mar 31, 2021
Issued at HKT 15:00
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