Home / Recalls / Shoreside Enterprises Inc. / D-0880-2018

D-0880-2018 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

7K capsules packaged in single packs sold in 24-count boxes, Distributed by SX Power Co. San Diego, CA 92108, UPC 601577513148

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 #: RO, Exp. 12/31/2021