被 發 現 含 有 未 標 示 西 藥 的 產 品
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| The United States: Ultra Supplement LLC issues voluntary nationwide recall of Sustango due to the presence of undeclared tadalafil (English only) |
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The US Food and Drug Administration (FDA) announces that Ultra Supplement LLC is voluntarily recalling lot number DAP272109 of Sustango capsules to the consumer level. Ultra Supplement 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 Sustango 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 Sustango capsules with undeclared tadalafil may experience 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, Ultra Supplement has not received any reports of adverse events related to this recall.
The product is marketed as a dietary supplement for male enhancement and is packaged in 10-count blisters packaged in a carton.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/ultra-supplement-llc-issues-voluntary-nationwide-recall-sustango-due-presence-undeclared-tadalafil
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Tuesday, Jul 26, 2022
Issued at HKT 14:00
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