被 发 现 含 有 未 标 示 西 药 的 产 品
|
| |
| The United States: Today The World issues voluntary nationwide recall of all lots of Arize herbal dietary supplement capsules due to the presence of undeclared nortadalafil (English only) |
| |
The US Food and Drug Administration (FDA) announces that Today The World is voluntarily recalling Arize herbal dietary supplement capsules to the consumer level. FDA analysis has found the products to contain undeclared nortadalafil (structurally similar to tadalafil). Nortadalafil is an active drug ingredient known for treatment of male erectile dysfunction. The presence of nortadalafil in Arize makes this an unapproved new drug for which the safety and efficacy has not been established and, therefore subject to recall.
Consumption of products with undeclared nortadalafil 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. To date, no adverse events have been reported.
This tainted product is marketed as a dietary supplement for male sexual enhancement.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/today-world-issues-voluntary-nationwide-recall-all-lots-arize-herbal-dietary-supplement-capsules-due
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 31 Jan 2024.
Ends/Tuesday, Feb 6, 2024
Issued at HKT 15:00
|
| |
|
