D-1041-2014 Class II Terminated
FDA drug recall D-1041-2014 was initiated by The Mentholatum Co. on January 16, 2014 and is designated Class II. 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 st… The recall status is terminated (terminated June 1, 2018).
Recall Details
- Product Type
- Drugs
- Report Date
- February 5, 2014
- Initiation Date
- January 16, 2014
- Termination Date
- June 1, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
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.
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 Pattern
Nationwide and Puerto Rico
Code Information
Stock No: 1074; Case UPC: 3 10742 81074 (5); Item UPC 3 10742 01074 9