7K capsules packaged in single packs sold in boxes 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 7K capsules packaged in single packs sold in 24-count boxes, Distributed by SX Power Co. San Diego, CA 92108, UPC 60157…

Recall number

D-0880-2018

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

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