PremierZen Black 5000

Finding published by the FDA

Finding date: 17 December 2020.

Undeclared sildenafil and tadalafil

FDA finding date: 17 December 2020
Company: Various Distributors; Recall by Namoo Enterprise LLC
Subject published by the FDA: Undeclared sildenafil and tadalafil
Published action: Public Notification
Programme: Drugs
Published follow-up: News ReleaseRecallUntitled Letter

This official finding is dated and does not necessarily describe the product currently sold under this name. It does not constitute an analysis of its complete composition.

The subject and action are reproduced as published by the FDA, without generalisation to all batches or other products from the company.

Substances named in the FDA finding

Published name	Published text and quantity	Recognised ingredient	Role or context
sildenafil	Undeclared sildenafil and tadalafil	Not recognised	Substance named by the FDA
tadalafil	Undeclared sildenafil and tadalafil	Not recognised	Substance named by the FDA

Substances named in the FDA finding do not constitute a complete composition. No quantity or dose is inferred.

Public register data after personal data protection

[
  {
    "action": "Public Notification",
    "company": "Various Distributors; Recall by Namoo Enterprise LLC",
    "date": "2020-12-17",
    "fda_urls": [
      "https://www.fda.gov/drugs/medication-health-fraud/public-notification-premierzen-black-5000-contains-hidden-drug-ingredients",
      "https://web.archive.org/web/20240112210928/https://www.fda.gov/news-events/press-announcements/fda-warns-consumers-avoid-certain-male-enhancement-and-weight-loss-products-sold-through-amazon-ebay",
      "https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/namoo-enterprise-llc-issues-voluntary-nationwide-recall-premierzen-black-5000-due-presence",
      "https://www.fda.gov/media/151096/download"
    ],
    "outcome": "News ReleaseRecallUntitled Letter",
    "product": "PremierZen Black 5000",
    "program": "Drugs",
    "source": "amazon.com",
    "subject": "Undeclared sildenafil and tadalafil"
  }
]

Official source

View the FDA finding