The Recall Desk
SevereFDA (Drugs)·D-1039-2014·Announced 2014-02-05

Mentholatum Recalls Rohto Eye Drops Due to Sterility Concerns

The Mentholatum Company is recalling several Rohto eye drop products due to concerns about the quality assurance of sterility controls.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, FDA Class II recalls involving significant injury/property-damage reports or hospitalization are Severe. While specific injury reports are not detailed in the text, the agency classification of Class II for a sterile medical product places it in the Severe category (Score 4) as it is not Class I (Critical) but involves a significant quality assurance failure regarding sterility.

Plain-English summary

The Mentholatum Company has issued a recall for Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief, and Rohto Cool eye drops. The recall is being conducted due to concerns related to the quality assurance of sterility controls for these products.

The recalled products are sterile lubricant eye drops manufactured by Rohto-Mentholatum (Vietnam) Co., Ltd. for The Mentholatum Company. The specific product identified in the structured data is ROHTO Dry Eye, hydra, Lubricant Eye Drops, Sterile, Net. Wt. 0.4 FL OZ (13 mL), with Stock No. 1096 and Item UPC 3 10742 01096 1.

Consumers who have purchased these products should stop using them and contact The Mentholatum Company for further instructions or a refund. The recall covers distribution nationwide and in Puerto Rico.

The recalled product

Product
ROHTO Dry Eye, hydra, Lubricant Eye Drops, Sterile, Net. Wt. 0.4 FL OZ (13 mL). UPC 3 10742 01096 1, Manufactured by Rohto-Mentholatum (Vietnam) Co., Ltd. for The Mentholatum Company, Orchard Park, NY 14127. Made in Vietnam.
Manufacturer
The Mentholatum Co.
Category
Drug — Ophthalmic
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Stock No: 1096
  • Case UPC: 3 10742 91096 (4)
  • Item UPC 3 10742 01096 1

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 5 recalled by The Mentholatum Co. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

Related recalls

Same manufacturer · The Mentholatum Co.

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Same hazard · sterility failure

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