The Recall Desk
CriticalFDA (Drugs)·D-0879-2018·Announced 2018-06-06

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.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. 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
Hazard

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

Same manufacturer · Shoreside Enterprises Inc.

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Same hazard · undeclared ingredients

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