# FDA recall D-0105-2018

> **Gadget Island, Inc** · Class I · drug recall initiated 2017-09-15.

## Product

FIFTY SHADES 6000 capsule, Proprietary Raw Material 4550, 1-capsule packets, distributed by Express Pac Trading, UPC 4026666146056

## Reason for recall

Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0105-2018
- **Recalling firm:** Gadget Island, Inc
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-09-15
- **Report date:** 2017-12-13
- **Termination date:** 2018-12-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Newark, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0105-2018

## Citation

> AI Analytics. FDA recall D-0105-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0105-2018. Source: US FDA. Licensed CC0.

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