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

Recall Number: D-0880-2018

Firm: Shoreside Enterprises Inc.

Classification: Class I

Status: Terminated

Report Date: 20180606

Initiation Date: 20180517

Termination Date: 20200610

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.

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