Public Alert No. 025/2021- Alert on Recall of Poseidon Platinum 3500 by Yamtun7 Due to the Presence of Undeclared Tadalafil and Sildenafil
July 30, 2021,
The National Agency for Food and Drug Administration and Control has been informed by the U.S. Food and Drug Administration that Yamtun7 is voluntarily recalling all lots of Poseidon Platinum 3500. The result of analysis by FDA 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.
Poseidon Platinum 3500 is marketed as a dietary supplement for male sexual enhancement.
These undeclared ingredients may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.
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.
Product Detail: The details of the recalled products are as follows;
Product Name: Poseidon Platinum 3500
Product Manufacturer: Yamtun7, Delray Beach, Florida.
NAFDAC implores consumers to stop the purchase and use of Poseidon Platinum 3500. Members of the public in possession of the implicated product are implored to handover product to the nearest NAFDAC office.
Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to using the implicated products.
NAFDAC encourages healthcare professionals, consumers and patients to report adverse events related to the use of this product to the nearest NAFDAC office, NAFDAC PRASCOR (20543 TOLLS FREE from all networks) or via firstname.lastname@example.org, E- reporting platforms available on the NAFDAC website or via the Med- safety application available for download on android and IOS stores.