FDA MedWatch - PremierZen Gold 7000, PremierZen Platinum 8000 and MaxxZEN Platinum 12000 by Miracle8989:

Recall - Due to Presence of Undeclared Sildenafil and Tadalafil

MedWatch - The FDA Safety Information and Adverse Event Reporting Program TOPIC: PremierZen Gold 7000, PremierZen Platinum 8000 and MaxxZEN Platinum 12000 by Miracle8989: Recall - Due to Presence of Undeclared Sildenafil and Tadalafil AUDIENCE: Consumer, Health Professional ISSUE: Miracle8989 is recalling all lots PremierZen Gold 7000, PremierZen Platinum 8000 and MaxxZEN Platinum 12000 - capsules because FDA analysis has found the products to contain undeclared sildenafil and tadalafil. 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. Consumers with underlying medical issues who take PremierZen Gold 7000, PremierZen Platinum 8000 and MaxxZEN Platinum 12000 with undeclared sildenafil and tadalafil 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, the company 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: Sildenafil and tadalafil are ingredients known as PDE-5 inhibitors found in FDA approved products for the treatment of male erectile dysfunction. The tainted PremierZen Gold 7000, PremierZen Platinum 8000 and MaxxZEN Platinum 12000 products are marketed as dietary supplements for male sexual enhancement. RECOMMENDATIONS:  Consumers that have PremierZen Gold 7000, PremierZen Platinum 8000 and MaxxZEN Platinum 12000 which is being recalled should stop using it. Consumers should contact their physician 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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