Namoo Enterprise PremierZen Black 5000: recall – due to undeclared presence of sildenafil and tadalafil
Namoo Enterprise LLC is recalling all lots before the expiration date of PremierZen Black 5000 capsules because an FDA analysis found the product to contain undeclared sildenafil and tadalafil. The presence of sildenafil and tadalafil in PremierZen Black 5000 products makes them new, unapproved drugs for which the safety and efficacy have not been established and therefore subject to recall.
Consumers with underlying medical conditions who take PremierZen Black 5000 with undeclared sildenafil and tadalafil may present serious health risks. For example, phosphodiesterase (PDE-5) inhibitors may interact with nitrates found in some prescription drugs (like nitroglycerin) by lowering blood pressure to dangerous, life-threatening levels. 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.
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BACKGROUND: Sildenafil and tadalafil, known as PDE-5 inhibitors, are found in products approved by the FDA for the treatment of erectile dysfunction in men. The contaminated product is marketed as a dietary supplement for male sexual enhancement.
Consumers who have PremierZen Black 5000 should stop using them and destroy them.
Consumers should contact their doctor or health care provider if they have had any problems that may be related to taking or using this medication.
Healthcare professionals and consumers are encouraged to report any adverse events or side effects associated with the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.
Complete and submit the report online.
Download the form or call 1-800-332-1088 to request a report form, then fill it out and return it to the address on the form, or fax it to 1-800-FDA- 0178.