被 发 现 含 有 未 标 示 西 药 的 产 品
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| The United States: Med Man Issues Voluntary Nationwide Recall of Up2 Due to Presence of Undeclared Sildenafil (English only) |
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The United States Food and Drug Administration (FDA) announces that Med Man Distribution is voluntarily recalling all lots of “Up2 Dietary supplement There is no other all-natural libido for men and women” to the consumer level.
FDA laboratory analysis has found “Up2 Dietary supplement There is no other all natural libido for men and women” to be tainted with sildenafil. Sildenafil is an FDA-approved prescription drug for erectile dysfunction. The presence of sildenafil in Up2 products renders them unapproved drugs for which safety and efficacy have not been established, therefore subject to recall.
This undeclared ingredient 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. People 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, Med Man has not received any reports of adverse events related to this recall.
Med Man is notifying its distributors and their customers by written email and is arranging for destruction of all recalled products. Consumers that have “Up2 Dietary supplement There is no other all natural libido for men and women” which is being recalled should stop using and return to retailer for refund.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/med-man-issues-voluntary-nationwide-recall-up2-due-presence-undeclared-sildenafil
Local Situation in Hong Kong: In Hong Kong, the above product is not a registered pharmaceutical product. Related news was previously issued by the FDA, and was posted on the Drug Office website on 17 Oct 2019.
Ends/ Saturday, November 9, 2019
Issued at HKT 12:00
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