被 發 現 含 有 未 標 示 西 藥 的 產 品
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| The United States: Brian Richardson DBA “In Tha Pink” issues voluntary nationwide recall of Kopi Jantan Tradisional Natural Herbs Coffee due to presence of undeclared sildenafil and tadalafil (English Only) |
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The US Food and Drug Administration (FDA) announces that Brian Richardson DBA “In Tha Pink”, is voluntarily recalling lots with the expiration of October 13, 2020 (13/10/2020) of ground Kopi Jantan Tradisional Natural Herbs Coffee to the consumer level. FDA analysis has found the product to be tainted with sildenafil and tadalafil. Sildenafil and tadalafil are FDA approved drugs for the treatment of male erectile dysfunction. The presence of these undeclared active ingredients renders the product an unapproved drug for which safety and efficacy has not been established and, therefore, subject to recall.
Consumption of a product with undeclared sildenafil and tadalafil may pose a threat to consumers because these active ingredients 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. Consumers 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, “In Tha Pink” has not received any reports of adverse events related to this recall.
The product is marketed as a dietary supplement for sexual enhancement and sold in individual 13 gram packages, with an expiration date of October 13, 2020 (13/10/2020) stamped on the back of the package. The recalled Kopi Jantan Tradisional Natural Herbs Coffee was distributed nationwide in the USA by online retail sites, including but not limited to Ebay and through mail orders, since September, 2017.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/Recalls/ucm635520.htm
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Tuesday, Apr 9, 2019
Issued at HKT 16:00
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