The Mentholatum Co. recalls ROHTO Cooling Eye Drops, Itch Relief, Soothes Itch & Burn, relief, Astringent, Lubricant, Redness Reliever Eye Drops, St
Recalled February 5, 2014 · FDA recall D-1040-2014 · The Mentholatum
Hazard
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. · FDA Class II
Sold at
Nationwide and Puerto Rico
Description
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.
Product
ROHTO Cooling Eye Drops, Itch Relief, Soothes Itch & Burn, relief, Astringent, Lubricant, Redness Reliever Eye Drops, Sterile, Net. Wt. 0.4 FL OZ (13 mL). UPC 3 10742 01099 2, Manufactured by Rohto-Mentholatum (Vietnam) Co., Ltd. for The Mentholatum Company, Orchard Park, NY 14127. Made in Vietnam.
Manufacturer(s)
The Mentholatum Co.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →