The Mentholatum Co.: 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.

Agency Publication Date: January 28, 2014

Affected Products

Product: ROHTO Redness Relief, arctic, Redness Reliever, Lubricant Eye Drops, Sterile, Net. Wt. 0.4 FL OZ (13 mL). UPC 3 10742 10909 2, Manufactured by Rohto-Mentholatum (Vietnam) Co., Ltd. for The Mentholatum Company, Orchard Park, NY 14127. Made in Vietnam.

Stock No: 1090; Case UPC: 3 10742 91080 (2); Item UPC 3 10742 10909 2

Product: ROHTO Redness Relief, ice, Redness Reliever, Lubricant, Astringent Eye Drops, Sterile, Net. Wt. 0.4 FL OZ (13 mL). UPC 3 10742 01086 2, Manufactured by Rohto-Mentholatum (Vietnam) Co., Ltd. for The Mentholatum Company, Orchard Park, NY 14127. Made in Vietnam.

Stock No: 1086; Case UPC: 3 10742 91086 (5); Item UPC 3 10742 01086 2

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.

Stock No: 1096; Case UPC: 3 10742 91096 (4); Item UPC 3 10742 01096 1

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.

Stock No: 1099; Case UPC: 3 10742 91099 (5); Item UPC 3 10742 01099 2

Product: ROHTO Redness Relief, Cool, Redness Reliever, Lubricant Eye Drops, Sterile, Net. Wt. 0.4 FL OZ (13 mL). UPC 3 10742 01074 9, Manufactured by Rohto-Mentholatum (Vietnam) Co., Ltd. for The Mentholatum Company, Orchard Park, NY 14127. Made in Vietnam.

Stock No: 1074; Case UPC: 3 10742 81074 (5); Item UPC 3 10742 01074 9

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 67314

Status: Resolved

Manufacturer: The Mentholatum Co.

Manufactured In: United States

Units Affected: 2 products (59, 376 units Total (32,184 units held in stock, quarantined); 94,080 units Total (432 units held in stock, quarantined))

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Sources: FDA iRES · Raw API Response

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