被 发 现 含 有 未 标 示 西 药 的 产 品
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| The United States: Distributor RFR, LLC issues voluntary nationwide recall of Sangter Energy Supplement due to presence of undeclared sildenafil (English only) |
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The US Food and Drug Administration (FDA) announces that Distributor RFR, LLC is voluntarily recalling lot #48656 of Sangter Energy Supplement 3000 mg to the consumer level. FDA analysis has found the product to contain undeclared sildenafil. Sildenafil is a phosphodiesterase (PDE-5) inhibitor found in FDA-approved products for the treatment of male erectile dysfunction. The presence of sildenafil in Sangter makes it an unapproved new drug for which the safety and efficacy has not been established and, therefore subject to recall.
Use of Sangter with undeclared sildenafil may pose a threat to consumers because it 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. To date, Distributor RFR, LLC has not received any reports of adverse events related to this recall.
The tainted product is marketed as a dietary supplement for male sexual enhancement and is packaged in a 7-count blister pack within a carton.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/distributor-rfr-llc-voluntary-nationwide-recall-sangter-energy-supplement-due-presence-undeclared
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Wednesday, Aug 3, 2022
Issued at HKT 18:00
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