Products found to contain undeclared medicines
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| The United States: Yamtun7 issues voluntary nationwide recall of Poseidon Platinum 3500 due to the presence of undeclared tadalafil and sildenafil |
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The US Food and Drug Administration (FDA) announces that Yamtun7 is voluntarily recalling all lots of Poseidon Platinum 3500 to the consumer level. FDA analysis has found the product to contain undeclared tadalafil and sildenafil. Tadalafil and sildenafil are drugs known as phosphodiesterase (PDE-5) inhibitors found in FDA approved products for the treatment of male erectile dysfunction. The presence of tadalafil and sildenafil in Poseidon Platinum 3500 makes it an unapproved new drug for which the safety and efficacy have not been established and, therefore subject to recall.
Consumers with underlying medical issues who take Poseidon Platinum 3500 with undeclared tadalafil and sildenafil 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, Yamtun7 has not received any reports of adverse events related to this recall.
This tainted 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/yamtun7-issues-voluntary-nationwide-recall-poseidon-platinum-3500-due-presence-undeclared-tadalafil
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Wednesday, May 12, 2021
Issued at HKT 15:00
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