He National Agency for Food and Drug Administration and Control (NAFDAC) on Sunday warned users/consumers against the use of PrimeZen Black 6000mg, a recalled male performance enhancement capsule. its Director General, Mojisola Adeyeye, and issued to the News Agency of Nigeria (NAN) in Abuja.
Ms. Adeyeye, a professor, said that Volt Candy is voluntarily recalling the batch of the PrimeZen Black 6000mg capsule along with the 2000mg capsule due to undeclared ingredients that their US manufacturer made from them.
“The recall followed an analysis by the United States Food and Drug Administration (FDA), an FDA, which found that PrimeZen capsules contained 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 6000 mg capsules makes them unapproved drugs for which safety and efficacy have not been established and therefore subject to withdrawal.
“Risk Statement, PrimeZen Black 6000 capsules containing sildenafil and tadalafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and cause a significant drop in blood pressure that can be life-threatening.
“People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.
“Among the adult male population most likely to use these products, adult men who use nitrates for heart conditions are at higher risk with these products,” he said.
She said: “The details of the product are as follows; PrimeZEN Black 6000 male enhancement capsules, manufactured by Volt Candy, 324 S. Diamond Bar Blvd #212, USA.”
The head of NAFDAC said the Lot Number: NPINPB 1003, UPC Code: 728175521891, Expiration Date is August 16, 2025, for PrimeZen Black 6000mg which is marketed online as a male enhancement dietary supplement and It is packed in a blister pack with one capsule.
Ms. Adeyeye added that the product can be identified by the color of the black card under the name 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 to turn the product over to the nearest agency office.”
The DG called on those with the counterfeit product to “DO NOT use it.”
“If you, or someone you know, has used the product or experienced any adverse reaction after use, seek immediate medical attention,” he advised.
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He advised healthcare professionals and consumers to report suspected adverse reactions to counterfeit and substandard medications or medications to the nearest NAFDAC office.
Ms Adeyeye also advised the public to report any adverse reactions to the product to NAFDAC at 0800-162-3322 or via email: alert@nafdac.gov.ng
The Director General also encouraged healthcare professionals and patients to report adverse events or side effects related to the use of medicines by using the electronic reporting platforms available on the NAFDAC website “http://www.nafdac.gov.ng/”
(YAYA)