Namoo Enterprise Recalls PremierZen Black 5000 Capsules for Unapproved Ingredients
Namoo Enterprise LLC is recalling PremierZen Black 5000 capsules because FDA analysis found unapproved ingredients tadalafil and sildenafil.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric, particularly given the presence of unapproved prescription drug ingredients.
Plain-English summary
Namoo Enterprise LLC is recalling PremierZen Black 5000 capsules, distributed by New Premier Group in Los Angeles, California. The product is sold in boxes of 24 capsules, with each capsule on a separate card. The recall covers all lots within their expiration dates and was distributed nationwide within the United States.
The recall was initiated because FDA analysis results indicated the presence of tadalafil and sildenafil in the product. These ingredients are active pharmaceutical ingredients found in prescription medications for erectile dysfunction. 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 Black 5000 capsules should stop using the product immediately. Individuals should consult their healthcare provider before taking any product containing tadalafil or sildenafil, as these ingredients can interact with other medications and may cause serious health issues. The recalling firm, Namoo Enterprise LLC, is responsible for the recall.
The recalled product
- Product
- PremierZen Black 5000 capsules, 1 capsule per card/24 capsules per box, Distributed by New Premier Group Los Angeles CA 90006 UPC 7 2817542189 4
- Manufacturer
- Namoo Enterprise LLC
- Category
- Drug — Supplement
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 within expiry
Distribution
Distributed nationwide across the United States.
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