# FDA recall D-0855-2017

> **Sato Pharmaceutical Inc.** · Class II · drug recall initiated 2017-02-16.

## Product

SATO CLEAR (naphazoline hydrochloride) Redness Reliever Eye Drops, packaged in 0.5 FL OZ (15mL) bottles, Manufactured by SATO Pharmaceuticals CO., LTD. 1-5-27 Motoakasaka Minato-Ku Tokyo, Japan, NDC 49873-044-01

## Reason for recall

Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.

## Distribution

US: Hawaii, Guam, Saipan, SPI

## Key facts

- **Recall number:** D-0855-2017
- **Recalling firm:** Sato Pharmaceutical Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-02-16
- **Report date:** 2017-05-31
- **Termination date:** 2018-03-13

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0855-2017

## Citation

> AI Analytics. FDA recall D-0855-2017. Retrieved 2026-06-01 from https://api.ai-analytics.org/recall/D-0855-2017. Source: US FDA. Licensed CC0.

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