PrimeZEN Black 6000, a male enhancement capsule, may cause a significant drop in blood pressure, which may be life-threatening.
The National Agency for Food and Drugs Administration and Control (NAFDAC) made a post on its Twitter page on Thursday to caution Nigerians against the sale and use of the product.
NAFDAC said the product is marketed online as a dietary supplement for male enhancement and is often packaged in a blister card with one capsule.
Public Alert No. 015/2023.
Recall of PrimeZEN Black 6000 male enhancement capsules due to undeclared ingredients #NafdacALERTShttps://t.co/7sD2bfXtiq pic.twitter.com/UgclOkghMX— NAFDAC NIGERIA (@NafdacAgency) May 11, 2023
“Volt Candy is voluntarily recalling one lot of PrimeZen Black 6000, 2000 mg capsule, to the consumer level,” NAFDAC stated.
The development came after an FDA analysis of PrimeZen Black 6000 capsules showed the presence of tadalafil and sildenafil, two undeclared ingredients.
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NAFDAC noted that adult males who use nitrates for cardiac conditions are primarily at risk if they use PrimeZEN Black 6000 male enhancement capsules.
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“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 capsules renders them unapproved drugs for which safety and efficacy have not been established and, therefore, subject to recall.”
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“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.”
