PrimeZEN Black 6000 Capsule Recalled for Undeclared Pharmaceutical Ingredients
The FDA is recalling PrimeZEN Black 6000 capsules distributed nationwide because they contain undeclared sildenafil and tadalafil. The product is unapproved and was marketed without FDA authorization.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This product has been classified as FDA Class I. Per the severity rubric, FDA Class I recalls are never scored below 4. The source text does not report deaths, hospitalizations, or confirmed injuries, preventing a Critical designation.
Plain-English summary
The FDA is recalling PrimeZEN Black 6000 capsules, a male sexual performance enhancement product distributed by Prime Premier Group, Los Angeles, California. The recalled product consists of 2,000mg capsules in 1-count blister cards with Lot Number NPINPB 1003, UPC 7 28175 52189 1, and expiration date of August 16, 2025. The product was distributed nationwide in the United States.
FDA analysis found that the product contains undeclared sildenafil and tadalafil, pharmaceutical ingredients that are found in FDA-approved products for male sexual enhancement. The product was marketed without approval. Specifically, there is no approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) for this product, making it an unapproved drug.
The recalled product
- Product
- PrimeZEN Black 6000 capsule, 2000mg, Male Sexual Performance Enhancement, 1-count blister card, Distributed by: Prime Premier Group, Los Angeles, CA 90006, UPC 7 28175 52189 1.
- Manufacturer
- Volt Candy Wholesale Club
- Hazard
- undeclared-sildenafil
- undeclared-tadalafil
- unapproved-drug
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot number: NPINPB 1003
- Expiration date: 08/16/2025
Distribution
Distributed nationwide across the United States.
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