被 發 現 含 有 未 標 示 西 藥 的 產 品
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| The United States: Med Man expands voluntary nationwide recall of Up2 and Bow & Arrow due to presence of undeclared sildenafil (English only) |
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The US Food and Drug Administration (FDA) announces that Med Man Distribution voluntarily recalled all lots of Up2 dietary supplement on 8 Nov 2019. The recall has expanded to include all lots of dietary supplement Bow and Arrow libido enhancer for men to the consumer level.
FDA laboratory analysis has found Up2 dietary supplement and Bow and Arrow to contain undeclared sildenafil. Sildenafil is an FDA-approved prescription drug for erectile dysfunction. The presence of sildenafil in Up2 and Bow and Arrow 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.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/med-man-expands-voluntary-nationwide-recall-up2-and-bow-arrow-due-presence-undeclared-sildenafil
In Hong Kong, the above products are not registered pharmaceutical products. Related news was previously issued by FDA, and was posted on the Drug Office website on 17 Oct 2019 and 9 Nov 2019.
Ends/Tuesday, Feb 25, 2020
Issued at HKT 15:00
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