FDA MedWatch - Poseidon Platinum 3500 by Yamtun7:

Recall - Due to the Presence of Undeclared Tadalafil and Sildenafil

MedWatch - The FDA Safety Information and Adverse Event Reporting Program TOPIC: Poseidon Platinum 3500 by Yamtun7: Recall - Due to the Presence of Undeclared Tadalafil and Sildenafil AUDIENCE: Consumer, Health Professional  ISSUE: Yamtun7 is recalling all lots of Poseidon Platinum 3500 because FDA analysis found the product to contain undeclared tadalafil and sildenafil. 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, phosphodiesterase (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. For more information about this recall, click on the red button "Read Recall" below. BACKGROUND: Poseidon Platinum 3500 is marketed as a dietary supplement for male sexual enhancement. Tadalafil and sildenafil are drugs known as PDE-5 inhibitors found in FDA approved products for the treatment of male erectile dysfunction.  RECOMMENDATIONS: FDA issued a press release that warned consumers to avoid certain products found on Amazon, eBay and other retailers due to hidden and potentially dangerous drug ingredients. It also encouraged online marketplaces to ensure these products are not sold on their platforms. Consumers that have Poseidon Platinum 3500, which is being recalled should stop using and destroy them. Consumers should contact their physicians or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Health professionals and consumers are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report online. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

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