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FDARecalled Jul 29, 2026 · #D-0717-2026

Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 80 0.2%), Sterile, TWIN PACK, 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, ...

Hazard

Class II — temporary health risk

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Description

Lack of Assurance of Sterility Classification: Class II Distribution: Nationwide within the United States

Product details

Product
Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 80 0.2%), Sterile, TWIN PACK, 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011210, NDC 10742-8158-2
Type
Drugs
Manufacturer
Rohto-Mentholatum (Vietnam) Co., Ltd.
Model numbers
3H1V
UPCs