The National Agency for Food and Drug Administration and Control (NAFDAC) has been informed by the U.S Food and Drug Administration that Irving, Texas, Miracle8989 is voluntarily recalling all lots of PremierZen Gold 7000, PremierZen Platinum 8000 and MaxxZEN Platinum 12000, capsules to the consumer level.
FDA analysis has reportedly found the products to contain undeclared sildenafil and tadalafil. 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 Sildenafil and Tadalafil in PremierZen Gold 7000, PremierZen Platinum 8000, and MaxxZEN Platinum 12000 renders them unapproved drugs for which safety and efficacy have not been established and, therefore, subject to recall.
The agency reportedly said that consumers who take these drugs may experience serious health risks.
Sildenafil and tadalafil are known as PDE-5 inhibitors found in FDA-approved products for the treatment of male erectile dysfunction. These tainted products are marketed as a dietary supplement for male sexual enhancement.
|COMPANY NAME||PRODUCTS||LOT NUMBER|
|Miracle8989||PremierZen Gold 7000||728175421832|
|Miracle8989||PremierZen Platinum 8000||728175421832|
|Miracle8989||MaxxZEN Platinum 12000||718122040728|
NAFDAC reportedly implored consumers, distributors, importers in possession of the recalled PremierZen Gold 7000, PremierZen Platinum 8000, and MaxxZEN Platinum 12000 to discontinue the sale or use and handover remaining stock to the nearest NAFDAC office.