drugs Class II Updated 2014-02-05

The Mentholatum Co. recalls ROHTO Dry Eye, hydra, Lubricant Eye Drops, Sterile, Net. Wt.

Recalled Product

ROHTO Dry Eye, hydra, Lubricant Eye Drops, Sterile, Net. Wt. 0.4 FL OZ (13 mL). UPC 3 10742 01096 1, Manufactured by Rohto-Mentholatum (Vietnam) Co., Ltd. for The Mentholatum Company, Orchard Park, NY 14127. Made in Vietnam.

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Stock No: 1096; Case UPC: 3 10742 91096 (4); Item UPC 3 10742 01096 1
View official government recall

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