Triple SupremeZen Gold 3500 Recalled for Unapproved Active Ingredients
Na Na Collection is recalling Triple SupremeZen Gold 3500 capsules because FDA analysis found unapproved active ingredients tadalafil and/or 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' rating under the rubric, particularly given the presence of unapproved active pharmaceutical ingredients that pose a risk of serious temporary or medically reversible adverse health consequences.
Plain-English summary
Na Na Collection is recalling Triple SupremeZen Gold 3500 capsules, which are packaged in paper packaging with a pill blister and contain one capsule per box. The product is distributed by VIEW LIFE Distributors in Los Angeles, California, and was distributed nationwide in the United States. The specific lot affected is GATCO 1805, with an expiration date of 12/30/2024 and serial number 715122050894.
The recall was initiated because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). FDA analysis of the product revealed the presence of tadalafil and/or sildenafil, which are active pharmaceutical ingredients not approved for this specific product listing.
Consumers who have purchased this product should stop using it and check their packaging for the specific lot number and expiration date listed above. If the product matches the recalled description, consumers should dispose of it or contact the distributor for further instructions.
The recalled product
- Product
- Triple SupremeZen Gold 3500, Packaged in paper packaging with a pill blister,1 capsule per box, Distributed by VIEW LIFE Distributors Los Angeles CA 90005 UPC 7 15122 05089 4
- 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 1805
- Exp. Date 12/30/2024 Serial # 715122050894
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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