Class II
Terminated
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.
This recall has been terminated (originally issued February 5, 2014).
- Company
- The Mentholatum Co.
- Recall Initiated
- January 16, 2014
- Posted
- February 5, 2014
- Recall Number
- D-1039-2014
- Voluntary / Mandated
- Voluntary: Firm initiated
- Firm Location
- Orchard Park, NY, United States
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Nationwide and Puerto Rico
Lot / Code Info
Stock No: 1096; Case UPC: 3 10742 91096 (4); Item UPC 3 10742 01096 1
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