The National Agency for Food and Drugs Administration and Control, on Sunday, raised the alarm over the use of PrimeZen Black 6000mg, a male sex enhancement pill manufactured in the United States.
NAFDAC revealed that the pill contains undeclared ingredients and has since been recalled following an analysis by the Food and Drug Agency.
The agency made this known in a public alert with No. 015/2023, signed by the Director-General, Professor Moji Adeyeye in Abuja.
It stated, “The recall followed the analysis of the drug by the Food and Drug Agency of the United States of America, an FDA, which found the PrimeZen capsules to contain undeclared tadalafil and sildenafil.
“Sildenafil and tadalafil are phosphodiesterase (PDE-5) inhibitors found in FDA-approved products for the treatment of male erectile dysfunction.
“The presence of sildenafil and tadalafil in PrimeZen Black 6000mg capsules renders them unapproved drugs for which safety and efficacy have not been established and, therefore, subject to recall.
“Risk Statement, PrimeZen Black 6000 capsules containing sildenafil and tadalafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may cause a significant drop in blood pressure that may be life-threatening.
“People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.
“Among the adult male population who are most likely to use these products, adult males who use nitrates for cardiac conditions are most at risk from these products.”
According to the statement, “The product details are as follows; PrimeZEN Black 6000 male enhancement capsules, manufactured by Volt Candy, 324 S. Diamond Bar Blvd #212, USA.
The statement further revealed, “Lot Number: NPINPB 1003, UPC code: 728175521891, the expiration date is August 16, 2025. PrimeZen Black 6000mg is being marketed online as a dietary supplement for male enhancement and is packaged in a blister card with one capsule.”
NAFDAC pointed out that the product can be identified by the card colour, which is black.
“NAFDAC, hereby, implores members of the public in possession of the above product to stop the sale or use, as well as hand over the product to the nearest agency office. Please do not use it.
“If you, or someone you know, have used the product, or suffered any adverse reaction after use, please seek immediate medical advice,” the agency advised.
NAFDAC implored healthcare professionals and consumers to report any suspicion of adverse drug reactions, or substandard and falsified medicines to its nearest office or through the E-reporting platforms on its NAFDAC website.