# FDA recall D-0880-2018

> **Shoreside Enterprises Inc.** · Class I · drug recall initiated 2018-05-17.

## 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.

## Distribution

Nationwide.

## Key facts

- **Recall number:** D-0880-2018
- **Recalling firm:** Shoreside Enterprises Inc.
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-05-17
- **Report date:** 2018-06-06
- **Termination date:** 2020-06-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Tampa, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0880-2018

## Citation

> AI Analytics. FDA recall D-0880-2018. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-0880-2018. Source: US FDA. Licensed CC0.

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