Recall D-0717-2026

US Class II Ongoing · initiated 2026-07-14

Recalling firm

Rohto-Mentholatum (Vietnam) Co., Ltd.

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

Reason for recall

Lack of Assurance of Sterility

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