被 发 现 含 有 未 标 示 西 药 的 产 品
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| The United States: Ata Int. Inc. issues voluntary nationwide recall of BLUEFUSION Capsules, due to presence of undeclared sildenafil, tadalafil, desmethyl carbodenafil, dithiodesmethyl carbodenafil, scutellarin and daidzein (English Only) |
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The US Food and Drug Administration (FDA) announces that Ata Int. Inc. is voluntarily recalling all lots within expiry of BLUEFUSION Capsules to the consumer level. FDA analysis has found the product to be tainted with sildenafil, tadalafil, desmethyl carbodenafil, dithiodesmethyl carbodenafil, scutellarin and daidzein. Sildenafil and tadalafil are FDA approved drugs for the treatment of male erectile dysfunction and are in a class of drugs called phosphodiesterase (PDE-5) inhibitors. Desmethyl carbodenafil and dithiodesmethyl carbodenafil are analogues of PDE-5 inhibitors and are likely to have the same pharmacological activity as PDE-5 inhibitors and thus carry the same clinical risks. Scutellarin and daidzein are derived from plants or herbs.
The presence of the 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 PDE-5 inhibitors may pose a threat to consumers because the 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, Ata Int. Inc. has not received any reports of adverse events related to this recall.
BLUE FUSION capsules were marketed as a dietary supplement for male enhancement and is packaged in 1-count blister packs.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/Recalls/ucm634124.htm
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Friday, Mar 22, 2019
Issued at HKT 16:00
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