FDA MedWatch - PremierZen Black 5000 by Namoo Enterprise: Recall -

Due to the Presence of Undeclared Sildenafil and Tadalafil

MedWatch - The FDA Safety Information and Adverse Event Reporting Program TOPIC: PremierZen Black 5000 by Namoo Enterprise: Recall - Due to the Presence of Undeclared Sildenafil and Tadalafil AUDIENCE: Consumer, Health Professional, Risk Manager, Pharmacy ISSUE: Namoo Enterprise LLC is recalling all lots within expiry of PremierZen Black 5000 capsules because FDA analysis has found the product to contain undeclared sildenafil and tadalafil. The presence of sildenafil and tadalafil in PremierZen Black 5000 products makes them unapproved new drugs for which the safety and efficacy have not been established and therefore subject to recall. Consumers with underlying medical issues who take PremierZen Black 5000 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, Namoo Enterprise LLC 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, known as PDE-5 inhibitors, are found in FDA approved products for the treatment of male erectile dysfunction. The tainted product is marketed as a dietary supplement for male sexual enhancement.  RECOMMENDATIONS:  Consumers that have PremierZen Black 5000 should stop using and destroy them. 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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