PremierZEN Platinum 8000 Capsules Recalled for Undeclared Drug Ingredients
PremierZEN Platinum 8000 capsules, distributed nationwide, are being recalled because the product contains undeclared pharmaceutical ingredients (Sildenafil and Tadalafil) and was marketed without FDA approval.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: This recall is classified FDA Class I by the agency, which corresponds to a Critical severity score per the rubric. Class I recalls indicate a serious health hazard where use of the product could cause serious adverse health consequences or death.
Plain-English summary
PremierZEN Platinum 8000 capsules, sold as 1-count blister cards (UPC 7 28175 42185 6) packaged in boxes of 12 (UPC 7 28175 42183 2), are being recalled due to the presence of undeclared Sildenafil and Tadalafil. The product was marketed and distributed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
The recall affects products distributed nationwide by New Premier Group, Los Angeles, CA 90006, which were manufactured by Miracle 8989. All lots remaining within expiration are included in this recall.
Consumers who have purchased this product should stop use immediately. Anyone experiencing adverse effects should consult a healthcare provider or contact poison control. Consumers may return the product to the place of purchase.
The recalled product
- Product
- PremierZEN Platinum 8000 capsule, 1-count blister card (UPC 7 28175 42185 6), packaged in 12 cards per box (UPC 7 28175 42183 2), Distributed by: New Premier Group, Los Angeles, CA 90006
- Manufacturer
- Miracle 8989
- Category
- Drug — Unapproved Drug Product
- Hazard
- unapproved-drug
- undeclared-sildenafil
- undeclared-tadalafil
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 remaining within expiry.
Distribution
Distributed nationwide across the United States.
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