FDA Recall D-0880-2018
Shoreside Enterprises Inc. · Tampa, FL
Class I — life-threatening Terminated 755 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
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.
Recall record
- Recall number
D-0880-2018- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Nationwide.
- Recall initiated
- 2018-05-17
- Classified by FDA Center
- 2018-06-18
- FDA published
- 2018-06-06
- Terminated
- 2020-06-10
- Recalling firm
- Shoreside Enterprises Inc.
- Firm location
- Tampa, FL