Recall Record

Tampa, FL, United States

Shoreside Enterprises Inc. recalls

1 recall recorded since 2018, most recently on 17 May 2018. None are listed as ongoing. Status and classification are as published by the FDA.

Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)1

Terminated Class I Drugs

Recall started
17 May 2018
Terminated
10 June 2020
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.
Distribution
Nationwide.
Initiated
Voluntary: Firm initiated
Recall numbers
D-0880-2018, D-0879-2018

A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.