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Recall Observatory FDA recall evidence

Drug product

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

D-0880-2018

May 17, 2018

Class I

Product summary

Firm
Shoreside Enterprises Inc.
Event
Event 80128
Status
Terminated
Classification
Class I
Quantity
Unknown
Official record key
drug-enforcement:D-0880-2018

Official wording

Reason: 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.

Code information: Lot #: RO, Exp. 12/31/2021

Distribution pattern: Nationwide.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.