Products found to contain undeclared medicines
|
| |
| The United States: NANA Collection LLC issues voluntary nationwide recall of PremierZen Platinum 5000 & Triple SupremeZen Gold 3500 due to presence of undeclared drug tadalafil and sildenafil |
| |
The US Food and Drug Administration (FDA) announces that NANA Collection LLC is voluntarily recalling all lots of PremierZen Platinum 5000 and Triple SupremeZen Gold 3500 to the consumer level. FDA analysis has found the PremierZen Platinum 5000 to contain undeclared tadalafil and Triple SupremeZen Gold 3500 to contain undeclared tadalafil and sildenafil. Sildenafil and tadalafil are ingredients 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 PremierZen Platinum 5000 and Triple SupremeZen Gold 3500 renders them unapproved drugs for which safety and efficacy have not been established and, therefore, subject to recall.
Consumers with underlying medical issues who take PremierZen Platinum 5000 with tadalafil and Triple SupremeZen Gold 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, NANA Collection LLC has not received any reports of adverse events related to this recall.
This tainted PremierZen Platinum 5000 and Triple SupremeZen Gold 3500 are marketed as dietary supplements for male sexual enhancement and are packaged in paper packaging with a pill blister, 1 capsule per package.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/nana-collection-llc-issues-voluntary-nationwide-recall-premierzen-platinum-5000-triple-supremezen
In Hong Kong, the above products are not registered pharmaceutical products.
Ends/Wednesday, Apr 7, 2021
Issued at HKT 16:00
|
| |
