The National Agency for Food and Drugs Administration and Control (NAFDAC) Sunday warned consumers against the use of PrimeZen Black 6000mg, a male performance enhancement capsule, recalled from the market.
NAFDAC Director-General, Mojisola Adeyeye, in a statement, said Volt Candy was voluntarily recalling the one lot of PrimeZen Black 6000mg capsule alongside its 2000mg due to undeclared ingredients they were made of by their manufacturer in America.
“The recall followed the analysis of Food and Drug Agency (FDA) 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,” she said.
According to her, “The product details are as follows; PrimeZEN Black 6000 male enhancement capsules, manufactured by Volt Candy, 324 S. Diamond Bar Blvd #212, USA.”
The NAFDAC boss said that the lot Number: NPINPB 1003, UPC code: 728175521891, expiration date is Aug. 16, 2025 for PrimeZen Black 6000mg being marketed online as a dietary supplement for male enhancement and is packaged in a blister card with one capsule.
She said the product can be identified by the card color in black with the name on it PrimeZen Black 6000.
She implored members of the public in possession of the product to stop its sale or use and hand it over to the nearest NAFDAC office.
(NAN)
