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.
Reported: February 5, 2014 Initiated: January 16, 2014 #D-1038-2014
Product Description
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.
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.
Details
- Recalling Firm
- The Mentholatum Co.
- Units Affected
- 94,080 units Total (432 units held in stock, quarantined)
- Distribution
- Nationwide and Puerto Rico
- Location
- Orchard Park, NY
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by The Mentholatum Co.. Units affected: 94,080 units Total (432 units held in stock, quarantined).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 5, 2014. Severity: Moderate. Recall number: D-1038-2014.
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