被 发 现 含 有 未 标 示 西 药 的 产 品
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| The United States: Positive-Health issues voluntary nationwide recall of Rise Up Red Edition Capsules due to the presence of undeclared tadalafil (English only) |
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The US Food and Drug Administration (FDA) announces that Positive-Health is voluntarily recalling Rise Up Red Edition Capsules (lot number: 48658908) packaged in 10-count blisters in a carton to the consumer level. Positive-Health was notified by Amazon that laboratory analysis has found the product to be tainted with tadalafil, an ingredient in FDA approved products for treatment of male erectile dysfunction in the family of drugs known as phosphodiesterase (PDE-5) inhibitors. The presence of tadalafil in Rise Up Red Edition Capsules makes this product an unapproved drug for which the safety and efficacy has not been established and therefore, subject to recall.
Consumers with underlying medical issues who take Rise Up Red Edition Capsules with undeclared tadalafil may experience serious health risks. For example, PDE-5 inhibitors may interact with nitrates found in some prescription drugs (such as nitroglycerin) lowering blood pressure to dangerous levels that may be life-threatening. Consumers with diabetes, high blood pressure, or heart disease often take nitrates. To date, Positive-Health has not received any reports of adverse events related to this recall.
The 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/positive-health-issues-voluntary-nationwide-recall-rise-red-edition-capsules-due-presence-undeclared
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Friday, Feb 11, 2022
Issued at HKT 14:00
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