- Company Announcement Date:
- May 11, 2021
- FDA Publish Date:
- May 11, 2021
- Product Type:
- Reason for Announcement:
Recall Reason Description
Undeclared Tadalafil and Sildenafil
- Company Name:
- Brand Name:
- Product Description:
Male Sexual Enhancement Dietary Supplement
Delray Beach, Florida, 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 and is packaged in a blue pack which contains one single blue pill with blue label and gold text with barcode 0 95842 05876 0. The affected lot numbers include all lots. Poseidon Platinum 3500 was distributed via internet and by eBay at www.ebay.com/usr/yamtun7store from July 1, 2019 to September 28, 2020 to nationwide in the USA. On December 17, 2020, 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.
Yamtun7 is notifying its customers by this press announcement and via e-mail of this recall. Consumers that have Poseidon Platinum 3500, which is being recalled should stop using and destroy them. Consumers with questions regarding this recall can contact Yamtun7 by phone at 561-674-3203 7 days of week from 9 am to 5 pm EDT or e-mail [email protected]. 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.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online
- Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.