FDAClass IIFebruary 5, 2014

ROHTO Redness Relief recall: Sterility Concern

ROHTO Redness Relief, arctic, Redness Reliever, Lubricant Eye Drops, Sterile, Net. Wt. 0.4 FL OZ (13 mL). UPC 3 10742 10909 2, Manufactured by…

Why was ROHTO Redness Relief recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Stock No: 1090; Case UPC: 3 10742 91080 (2); Item UPC 3 10742 10909 2

Product
ROHTO Redness Relief, arctic, Redness Reliever, Lubricant Eye Drops, Sterile, Net. Wt. 0.4 FL OZ (13 mL). UPC 3 10742 10909 2, Manufactured by…
Recalling firm
The Mentholatum Co.
Quantity
59, 376 units Total (32,184 units held in stock, quarantined)
Distribution
Nationwide and Puerto Rico
Recall date
February 5, 2014
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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