Certain lots of Rohto Arctic, Rhoto Ice, Rohto Hydra, Rohto Relief and Rohto Cool eye drops have been recalled due to sterility concerns, which could pose a potential health risk for users.
The Rohto eye drops recall was announced by the U.S. Food and Drug Administration on January 16, after the production plant recognized the potential for the eye relief products may be unsanitary for use. To date, no injuries or reports of side effects have been reported.
The recall includes Mentholatum Company’s retail level Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief, and Rohto Cool eye drop made in Vietnam. The affected products have lot numbers with the letter “V” in the code that can be located on the bottom of the carton and also on the bottom of the eye drop bottle. Only products which have the marking “Made in Vietnam” are included in the recall.
The products were manufactured by The Mentholatum Company which is a Japanese owned manufacturer of nonprescription medication. The eye drops are sold over-the-counter nationwide.
The FDA announced the firm is initiating the recall out of an abundance of caution and is currently sending notification to all distributors and retailers to cease distribution and sale from store shelves.
According to the recall notice, customers with affected products should discontinue using the eye drops and contact The Mentholatum Company Customer Service Department at 1-877-636-2677 for instructions. Customers are also encouraged to report any adverse side effects to the FDA’s MedWatch Adverse Event Reporting program online or by calling (800) 332-1088.