Mentholatum Recalls Rohto Eye Drops Due to Sterility Concerns
The Mentholatum Company is recalling Rohto eye drops because of concerns about sterility controls. The recall covers nationwide distribution and Puerto Rico.
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, which corresponds to a Severe severity score according to the rubric.
Plain-English summary
The Mentholatum Company is recalling 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 59,376 units, with 32,184 units held in stock and quarantined. Distribution was nationwide and in Puerto Rico.
Consumers should stop using the recalled eye drops and contact The Mentholatum Company for further instructions. The FDA has classified this recall as Class II.
The recalled product
- 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 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: 1090
- Case UPC: 3 10742 91080 (2)
- Item UPC 3 10742 10909 2
Distribution
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.
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