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The National Agency for Food and Drugs Administration and Control (NAFDAC) on Sunday warned users/consumers against using PrimeZen Black 6000mg, a male performance enhancement capsule recalled from the market.
This is contained in a public alert with No. 015/2023, signed by its director-general, Mojisola Adeyeye, in Abuja.
Ms Adeyeye said that Volt Candy is 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 the 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.”
She said the drugs may interact with nitrate found in some prescription drugs and reduce blood pressure, which could be life-threatening.
“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.
“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: 728175521891, the expiration date is August 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.
Ms Adeyeye added that the product can be identified by the card colour in black with the name on it PrimeZen Black 6000.
She said, “NAFDAC hereby implores members of the public in possession of the above product to stop the sale or use, as well as handover the product to the nearest agency office.”
She advised healthcare professionals and consumers to report any suspected adverse drug reactions or substandard and falsified medicines to the nearest NAFDAC office.
(NAN)
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