被 發 現 含 有 未 標 示 西 藥 的 產 品
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| The United States: STIFF BOY LLC. issues voluntary nationwide recall of THE BEAST capsules due to presence of undeclared sildenafil (English only) |
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The US Food and Drug Administration (FDA) announces that STIFF BOY LLC. is voluntarily recalling all lots within expiry of The Beast capsules to the consumer level. FDA analysis has found the product to be tainted with sildenafil. Sildenafil is an FDA approved drug for the treatment of male erectile dysfunction and is in a class of drugs called phosphodiesterase (PDE-5) inhibitors.
The presence of sildenafil in THE BEAST capsules renders it an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.
Consumption of a product with undeclared PDE-5 inhibitors may pose a threat to consumers because the active ingredients may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels which can be life threatening. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates and may be the population most likely to be affected. To date, STIFF BOY LLC. has not received any reports of adverse events related to this recall.
The product is marketed as a dietary supplement for male enhancement and is packaged in blue wrapping and blue box with an image of a beast, 4 capsules per package with no UPC barcode. All lots within expiry are being recalled. Product was distributed nationwide in the USA to online customers.
Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/stiff-boy-llc-issues-voluntary-nationwide-recall-beast-capsules-due-presence-undeclared-sildenafil
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Wednesday, May 8, 2019
Issued at HKT 15:00
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