Public Alert No. 0012/2021 – PremierZen Black 5000 by Namoo Enterprise: Recall – Due to Presence of Undeclared Sildenafil and Tadalafil
April 15, 2021,
The National Agency for Food and Drugs Administration and Control (NAFDAC) has received information from the US FDA that Namoo Enterprise LCC is recalling all lots of PremierZen Black 5000 capsules because FDA analysis has found out that the product contains undeclared Sildenafil and Tadalafil.
Sildenafil and Tadalafil are ingredients known as phosphodiesterase (PDE-5) inhibitors found in approved products for the treatment of male erectile dysfunction. The presence of Sildenafil and Tadalafil in PremierZen Black 5000 capsules make them unapproved drugs for which safety and efficacy have not been established.
Consumers with underlying medical issues who take PremierZen Black 5000 capsules with undeclared Sildenafil and Tadalafil 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.
PremierZen Black 5000 capsules are marketed as dietary supplements for male sexual enhancement. The products are being distributed via the internet.
PremierZen Black 5000 capsules is packaged in card form with one capsule per card.
|Product name||PremierZen Black 5000 capsules|
|Company Name||Namoo Enterprise LCC|
Below are product images for ease of identification:
- Consumers in possession of PremierZen Black 5000 capsules being recalled should stop using them and hand them over at the nearest NAFDAC office.
- Consumers should contact their physicians or healthcare provider if they have experienced any problems that may be related to taking or using these drug products.
- Online marketplaces are to ensure that the products being recalled are not sold on their platforms.
- All importers, wholesalers and retailers are implored to desist from illegal importation, distribution and sale of these products
Healthcare providers and Patients are advised to report adverse events and quality problems they experience with use of medicines and other medical products to the nearest NAFDAC office, NAFDAC PRASCOR (20543 TOLLS FREE from all networks), via firstname.lastname@example.org, the MedSafety app or via the e-reporting platform available on the NAFDAC website