# FDA recall D-1041-2014

> **The Mentholatum Co.** · Class II · drug recall initiated 2014-01-16.

## Product

ROHTO Redness Relief, Cool, Redness Reliever, Lubricant Eye Drops, Sterile, Net. Wt. 0.4 FL OZ (13 mL).  UPC 3 10742  01074 9,  Manufactured by Rohto-Mentholatum (Vietnam) Co., Ltd. for The Mentholatum Company, Orchard Park, NY 14127.   Made in Vietnam.

## Reason for recall

Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief and Rohto Cool eye drops, due to concerns related to the quality assurance of sterility controls.

## Distribution

Nationwide and Puerto Rico

## Key facts

- **Recall number:** D-1041-2014
- **Recalling firm:** The Mentholatum Co.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2014-01-16
- **Report date:** 2014-02-05
- **Termination date:** 2018-06-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Orchard Park, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1041-2014

## Citation

> AI Analytics. FDA recall D-1041-2014. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-1041-2014. Source: US FDA. Licensed CC0.

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