POSEIDON Xtreme PLATINUM 4500 recalled over undeclared sildenafil

Recall date

May 17, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Shoreside Enterprises Inc. recalls POSEIDON Xtreme PLATINUM 4500,1000mg, packaged in single packs sold in 24-count boxes, Distributed by: Poseidon Distrib…

Recall number

D-0879-2018

FDA classification

Class I

Brand / firm

Shoreside Enterprises Inc.

Sold / distributed

Nationwide.

Why it was recalled

Marketed Without An Approved NDA/ANDA: FDA analysis found products to contain undeclared sildenafil and tadalafil. The presence of sildenafil and tadalafil makes these products an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

POSEIDON Xtreme PLATINUM 4500,1000mg, packaged in single packs sold in 24-count boxes, Distributed by: Poseidon Distribution Atlanta, GA, UPC 638632428857