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.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
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.
Part of a larger recall action
This product is one of 3 recalled by Miracle 8989 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.
See all 3 products in this recall →Related recalls
Same manufacturer · Miracle 8989
See all →- CriticalPremierZEN Platinum 8000 Capsules Recalled for Undeclared Drug Ingredients
FDA (Drugs) · 2021-06-30
- SeveremaXXzen Platinum 12000 Capsule Recalled for Undisclosed Drug Contaminants
FDA (Drugs) · 2021-06-30
Same hazard · undisclosed sildenafil
See all →- SevereWEFUN Capsules Recalled: Unapproved Drug with Undisclosed Sildenafil
FDA (Drugs) · 2023-09-20
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