The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1041-2014·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.

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 agency classification is FDA Class II. The hazard involves a lack of assurance of sterility in eye drops, which is a significant risk of harm (infection) even without reported illnesses, fitting the 'Severe' criteria for significant injury risk or high-risk contamination.

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 lubricant eye drops manufactured by Rohto-Mentholatum (Vietnam) Co., Ltd. for The Mentholatum Company. The recall covers products 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 recalled product

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.
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: 1074
  • Case UPC: 3 10742 81074 (5)
  • Item UPC 3 10742 01074 9

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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