被 发 现 含 有 未 标 示 西 药 的 产 品
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| The United States: Natural Remedy Store issues voluntary worldwide recall of Active Male due to presence of undeclared tadalafil (English only) |
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The US Food and Drug Administration (FDA) announces that Natural Remedy Store is voluntarily recalling all lots of Active Male, 500mg capsules to the consumer level. FDA analysis has found the product to be tainted with undeclared tadalafil. Tadalafil is an FDA approved drug indicated for the treatment of male erectile dysfunction. The presence of tadalafil in this product renders it an unapproved drug for which safety and efficacy has not been established and, therefore, subject to recall.
Consumption of a product with undeclared tadalafil may pose a risk to consumers who take prescription medications containing nitrates (such as nitroglycerin). The combination of tadalafil and nitrates 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, Natural Remedy Store has not received any adverse events related to this recall.
The tainted Active Male product is marketed as a dietary supplement for male enhancement to boost sexual performance and is packaged in small foldable cardboard with the image of a Trojan helmet and the name Active Male with BN: Nd6332. The product was distributed at the Natural Remedy Store in San Antonio TX and through the NaturalRemedyStore.com website.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/natural-remedy-store-issues-voluntary-worldwide-recall-active-male-due-presence-undeclared-tadalafil
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Tuesday, Mar 17, 2020
Issued at HKT 15:00
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