The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1038-2014·Announced 2014-02-05

Mentholatum Recalls Rohto Eye Drops Due to Sterility Concerns

The Mentholatum Company is recalling Rohto eye drops because of concerns about the quality assurance of sterility controls.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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, an FDA Class II recall with potential for adverse health consequences (such as sterility failure in eye drops) corresponds to a severity score of 4 (Severe), especially given the lack of reported illnesses but the inherent risk of infection.

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 due to concerns related to the quality assurance of sterility controls for these products.

The affected products are sterile eye drops manufactured by Rohto-Mentholatum (Vietnam) Co., Ltd. for The Mentholatum Company. The recall covers 94,080 units in total, with 432 units held in stock and quarantined. The products were distributed nationwide and in Puerto Rico.

Consumers should stop using the recalled eye drops and contact The Mentholatum Company for further instructions or a refund. The recall is classified as FDA Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
ROHTO Redness Relief, ice, Redness Reliever, Lubricant, Astringent Eye Drops, Sterile, Net. Wt. 0.4 FL OZ (13 mL). UPC 3 10742 01086 2, 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: 1086
  • Case UPC: 3 10742 91086 (5)
  • Item UPC 3 10742 01086 2

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 →

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