PremierZEN Gold 7000 Capsule Recalled for Undisclosed Drug Contamination
PremierZEN Gold 7000 capsules are recalled nationwide because the product contains undisclosed pharmaceutical ingredients Sildenafil and Tadalafil and was marketed without FDA approval.
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 FDA classified this as Class I because the product was marketed without regulatory approval and contains undisclosed pharmaceutical ingredients that pose a safety risk. Undisclosed Sildenafil and Tadalafil can cause serious health effects in certain populations, particularly those taking blood pressure medications or with cardiovascular conditions.
Plain-English summary
PremierZEN Gold 7000 capsules, sold in 1-count blister cards packaged 12 per box, are being recalled nationwide. The product is manufactured by Miracle 8989 and distributed by New Premier Group, Los Angeles, CA.
The FDA classified this as a Class I recall because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) and contains the pharmaceutical ingredients Sildenafil and Tadalafil, which are not declared on the label.
Consumers who have purchased this product should not use it. Anyone who has consumed this product and experiences symptoms should consult a healthcare provider. All lots of this product that remain within their expiration date are subject to this recall.
The recalled product
- Product
- PremierZEN Gold 7000 capsule, 1-count blister card, packaged in 12 cards per box (UPC 7 28175 42183 2), Distributed by: New Premier Group, Los Angeles, CA 90006
- Manufacturer
- Miracle 8989
- Hazard
- undisclosed-sildenafil
- undisclosed-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 (1)
- All lots remaining within expiry.
Distribution
Distributed nationwide across the United States.
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