The National Agency for Food and Drugs Administration and Control (NAFDAC) has issued a public alert with No. 015/2023 warning Nigerians against the use of PrimeZen Black 6000mg capsules recalled from the market. The alert comes as a result of undeclared ingredients in the capsules, tadalafil, and sildenafil, found during an analysis by the Food and Drug Agency (FDA) of the United States of America.
Undeclared Ingredients Make PrimeZen Black 6000mg Capsules Unsafe
The presence of undeclared tadalafil and sildenafil in PrimeZen Black 6000mg capsules means that they are unapproved drugs. The safety and efficacy of the drugs have not been established, and hence the recall. NAFDAC Director-General, Prof Mojisola Adeyeye, has warned that the capsules may interact with nitrates found in some prescription drugs, causing a significant drop in blood pressure that may be life-threatening.
Members of the Public Urged to Report Any Adverse Reactions
NAFDAC has urged members of the public who are in possession of the recalled product to stop the sale or use and hand it over to the nearest agency office. Adeyeye also encouraged healthcare professionals and patients to report any adverse events or side effects related to the use of medicinal products through the E-reporting platforms available on the NAFDAC website. NAFDAC can also be reached on 0800-162-3322 or via email at email@example.com.
Recalled PrimeZen Black 6000mg Capsules Details
The details of the product are PrimeZEN Black 6000 male enhancement capsules, manufactured by Volt Candy, 324 S. Diamond Bar Blvd #212, USA. The lot number is NPINPB 1003, and the UPC code is 728175521891. The expiry date is Aug. 16, 2025. The capsules are being marketed online as a dietary supplement for male enhancement and are packaged in a blister card with one capsule.