FDA Recalls PremierZen Extreme 3000 for Unapproved Tadalafil
Hyobin LLC is recalling PremierZen Extreme 3000 capsules because FDA analysis found the unapproved drug tadalafil. The product was marketed without an approved NDA or ANDA.
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: The recall is classified as FDA Class II, which corresponds to a Severe severity score (4) under the rubric. The presence of an unapproved prescription drug (tadalafil) in a consumer product represents a significant health risk.
Plain-English summary
Hyobin LLC is recalling PremierZen Extreme 3000, a product packaged in cardboard blisters containing one capsule per card. The product was distributed by Yolo Studio in Cliffside Park, NJ, and was available nationwide in the United States. The recall involves 500 cards across all lots.
The recall was initiated because FDA analysis results indicated the presence of tadalafil, a prescription drug. The product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA), meaning it was not approved by the FDA for sale.
Consumers who have purchased PremierZen Extreme 3000 should stop using the product and contact the distributor or retailer for a refund or further instructions. The presence of unapproved pharmaceutical ingredients in dietary supplements can pose health risks, particularly for individuals with certain medical conditions or those taking other medications.
The recalled product
- Product
- PremierZen Extreme 3000, packaged in cardboard blisters containing one capsule per card, Distributed by Yolo Studio, Cliffside Park, NJ
- Manufacturer
- Hyobin LLC
- Category
- Drug — Dietary Supplement
- Affected units
- 500
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 (1)
- all lots
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Hyobin LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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