被 发 现 含 有 未 标 示 西 药 的 产 品
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| The United States: Alpha Male Plus Issues Voluntary Nationwide Recall of Alpha Male Plus Male Enhancer Due to the Presence of Undeclared Tadalafil (English only) |
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The United States Food and Drug Administration (FDA) announces that Alpha Male Plus of Tucson, AZ, is voluntarily recalling all lots within expiry of Alpha Male Plus Male Enhancer fruit chews to the consumer level. FDA analysis has found the product to be tainted with tadalafil, an ingredient known as a phosphodiesterase (PDE-5) inhibitor found in a FDA approved product for the treatment of male erectile dysfunction. The presence of tadalafil in Alpha Male Plus Male Enhancer renders the product an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.
Consumers with underlying medical conditions who take Alpha Male Plus Male Enhancer with undeclared 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. As of 19 July 2021, Alpha Male Plus had 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/alpha-male-plus-issues-voluntary-nationwide-recall-alpha-male-plus-male-enhancer-due-presence
In Hong Kong, the above product is not a registered pharmaceutical product. Related news was previously issued by FDA, and was posted on the Drug Office website on 25 Feb 2021.
Ends/ Thursday, July 22, 2021
Issued at HKT 12:30
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