被 发 现 含 有 未 标 示 西 药 的 产 品
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| The United States: Noah’s Wholesale, LLC issues voluntary nationwide recall of The Rock due to presence of undeclared sildenafil (English only) |
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The US Food and Drug Administration (FDA) announces that Noah’s Wholesale, LLC is voluntarily recalling one lot of The Rock 1200mg/capsule (lot number: 03032021) to the consumer level. FDA analysis has found the product to be tainted with sildenafil. Sildenafil is an ingredient known as a Phosphodiesterase Inhibitor (PDE-5) found in FDA-approved products for the treatment of male erectile dysfunction. The presence of sildenafil in this product renders The Rock an unapproved drug for which the safety and efficacy has not been established and, therefore, subject to recall.
Consumption of products with undeclared sildenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may cause a significant drop in blood pressure that may be life threatening. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Among the adult male population, who are most likely to use this product, adult males who use nitrates for cardiac conditions are most at risk. Noah’s Wholesale, LLC has not received any reports of adverse events related to this recall to date.
This tainted product, The Rock, is marketed as a dietary supplement for male sexual enhancement and is packaged as a single pill in a blister pack.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/noahs-wholesale-llc-issues-voluntary-nationwide-recall-rock-due-presence-undeclared-sildenafil
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 20 Oct 2023.
Ends/Wednesday, Nov 22, 2023
Issued at HKT 14:30
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