Drug 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.
D-1041-2014
Product summary
- Event
- Event 67314
- Status
- Terminated
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
drug-enforcement:D-1041-2014
Official wording
Reason: 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.
Code information: Stock No: 1074; Case UPC: 3 10742 81074 (5); Item UPC 3 10742 01074 9
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility