# FDA recall D-0218-2018

> **SHISEIDO AMERICA INC.** · Class II · drug recall initiated 2017-12-14.

## Product

Shiseido Future Solutions LX Triple Points Bonus contains SPF 50+ (octinoxate 4.9%, octocrylebe 3.0%, oxybenzone 1.0% and zinc oxide 15.4%), packaged in 15 mL tubes, Shiseido Americas Corporation Dist. New York, NY 10022, NDC 58411-256-60

## Reason for recall

GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.

## Distribution

Product was distributed nationwide.

## Key facts

- **Recall number:** D-0218-2018
- **Recalling firm:** SHISEIDO AMERICA INC.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-12-14
- **Report date:** 2018-01-24
- **Termination date:** 2021-06-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** East Windsor, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0218-2018

## Citation

> AI Analytics. FDA recall D-0218-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0218-2018. Source: US FDA. Licensed CC0.

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