被 發 現 含 有 未 標 示 西 藥 的 產 品
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| The United States: SD Import issues voluntary nationwide recall of Aphrodisiac Capsules due to presence of undeclared sildenafil (English Only) |
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The US Food and Drug Administration (FDA) announces that SD Import, LLC is voluntarily recalling all lots of Aphrodisiac Capsules to the consumer level. The products have been found to be tainted with sildenafil. FDA analysis has found the product to be tainted with sildenafil. Sildenafil is an active pharmaceutical ingredient in FDA approved product used in the treatment of erectile dysfunction. The presence of sildenafil in Aphrodisiac Capsules renders it an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.
Consumers with diabetes, hypertension, high cholesterol or heart disease often take nitrates; consumption of undeclared sildenafil along with nitrates could result in a drop in blood pressure that is life-threatening and could result in serious adverse health consequences. To date, SD Imports, LLC has not received any reports of adverse events related to this recall.
Aphrodisiac Capsules are marketed as a dietary supplement for men for sexual enhancement and is packaged in a cardboard box with 12 plastic packs in a box. The product was distributed nationwide to retail stores, and a variety of online websites.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/Recalls/ucm635860.htm
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Friday, Apr 12, 2019
Issued at HKT 16:00
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