FDA Recalls PremierZen Platinum 5000 for Unapproved Active Ingredients
Na Na Collection is recalling PremierZen Platinum 5000 capsules because FDA analysis detected unapproved active ingredients 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. The presence of undeclared active pharmaceutical ingredients (tadalafil/sildenafil) in a consumer product represents a significant health risk, potentially leading to serious adverse health consequences for susceptible individuals.
Plain-English summary
Na Na Collection is recalling PremierZen Platinum 5000, a product packaged in paper packaging with a pill blister containing 1 capsule per box. The product is distributed by New Premier Group in Los Angeles, CA, and was distributed nationwide in the United States. The specific lot affected is GATCO 01671, with an expiration date of 12/30/2024 and serial number 728175421856.
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 confirmed the presence of tadalafil and/or sildenafil in the product. These are active pharmaceutical ingredients that were not declared on the product labeling.
Consumers who possess this specific lot of PremierZen Platinum 5000 should stop using the product and contact the recalling firm, Na Na Collection, for further instructions or a refund. The presence of undeclared prescription drug ingredients poses a risk to consumers, particularly those with certain medical conditions or those taking other medications that may interact with tadalafil or sildenafil.
The recalled product
- Product
- PremierZen Platinum 5000, Packaged in paper packaging with a pill blister, 1 capsule per box, Distributed by New Premier Group Los Angeles CA 90006
- Manufacturer
- Na Na Collection
- Category
- Drug — Unapproved 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 (2)
- Lot #: GATCO 01671
- Exp Date 12/30/2024 Serial # 728175421856
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Na Na Collection 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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