D-0879-2018 Class I Terminated

Recalled by Shoreside Enterprises Inc. — Tampa, FL

Recall Details

Product Type
Drugs
Report Date
June 6, 2018
Initiation Date
May 17, 2018
Termination Date
June 10, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
Unknown

Product Description

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

Reason for Recall

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.

Distribution Pattern

Nationwide.

Code Information

Lot #: 201117BL, Exp. 01/2020