Poseidon Platinum 3500 Capsules Recalled for Undeclared Prescription Drugs
Poseidon Platinum 3500 capsules are being recalled because they contain undeclared sildenafil and tadalafil, which are prescription drugs that were not approved for this product. The safety and efficacy of these undeclared ingredients have not been established.
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 recall as Class I, which indicates a serious health hazard. Undeclared prescription drugs with unapproved formulations present significant risk due to unknown safety and efficacy profiles.
Plain-English summary
Yamtun7, the manufacturer, is recalling Poseidon Platinum 3500 capsules (1-count per blister card, UPC 0 95842 05876 0) distributed by Poseidon and made in the USA. The product was found to contain undeclared sildenafil and tadalafil, which are prescription drugs.
The product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). Because sildenafil and tadalafil are unapproved drugs in this formulation, their safety and efficacy have not been established. All lots distributed between July 1, 2019 and September 28, 2020 are affected by this recall.
Consumers who have purchased this product should not use it. The exact distribution scope is unknown because the firm's eBay account was closed. Consult a healthcare provider with questions about this product.
The recalled product
- Product
- Poseidon Platinum 3500 capsule, 1-count per blister card, Distributed by: Poseidon, Made in the USA, UPC 0 95842 05876 0
- Manufacturer
- Yamtun7
- Category
- Drug — Unapproved Drug
- Affected units
- 36
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 distributed 07/01/2019 through 09/28/2020.
Distribution
Distribution scope not specified by the agency.
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