FDAFDA · Food and drugs·Recall number D-1041-2014
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.
Published February 5, 2014 · Recall initiated: January 16, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Press Release
Recall details
- Manufacturer
- The Mentholatum Co.
- Distributor
- Nationwide and Puerto Rico
- Lot
- Stock No: 1074; Case UPC: 3 10742 81074 (5); Item UPC 3 10742 01074 9
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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