FDA Recalls PremierZen Extreme 3000 for Unapproved Active Ingredients
QMart is recalling PremierZen Extreme 3000 capsules because FDA analysis found unapproved drugs tadalafil and/or sildenafil.
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 under the rubric for significant injury or health risk potential.
Plain-English summary
QMart is recalling 500 boxes of PremierZen Extreme 3000, Male Sexual Performance Enhancement, 1 Capsule (UPC 728175421887). The product was distributed nationwide in the United States.
The recall was initiated because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). FDA analysis results indicated the presence of tadalafil and/or sildenafil, which are prescription medications not approved for use in this over-the-counter product.
Consumers who have purchased this product should stop using it and contact the manufacturer or return it to the place of purchase for a refund. The recall covers all codes for the affected product.
The recalled product
- Product
- PremierZen Extreme 3000, Male Sexual Performance Enhancement, 1 Capsule, UPC 728175421887
- Manufacturer
- QMart
- Category
- Drug — 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
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by QMart 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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