Poseidon Platinum 4500 Recalled for Undeclared Sildenafil and Tadalafil
Shoreside Enterprises Inc. is recalling Poseidon Xtreme PLATINUM 4500 because FDA analysis found undeclared sildenafil and tadalafil, making it an unapproved drug.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.
Plain-English summary
Shoreside Enterprises Inc. is recalling POSEIDON Xtreme PLATINUM 4500, 1000mg, packaged in single packs sold in 24-count boxes. The product is distributed by Poseidon Distribution in Atlanta, GA, and carries UPC 638632428857. The specific lot number is 201117BL with an expiration date of 01/2020. The recall is nationwide.
The FDA initiated this recall because analysis found the products contain undeclared sildenafil and tadalafil. The presence of these ingredients makes the product an unapproved drug for which safety and efficacy have not been established. Consequently, the product is subject to recall under FDA regulations.
Consumers who possess this product should stop using it and contact the recalling firm or their healthcare provider for further instructions. The source text does not specify the number of units recalled or report any specific illnesses or injuries associated with the product.
The recalled product
- Product
- POSEIDON Xtreme PLATINUM 4500,1000mg, packaged in single packs sold in 24-count boxes, Distributed by: Poseidon Distribution Atlanta, GA, UPC 638632428857
- Manufacturer
- Shoreside Enterprises Inc.
- Category
- Drug — Unapproved Drug
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 #: 201117BL
- Exp. 01/2020
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Shoreside Enterprises Inc. 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 2 products in this recall →Related recalls
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