Recalls / Class II
Class IID-1037-2014
Product
ROHTO Redness Relief, arctic, Redness Reliever, Lubricant Eye Drops, Sterile, Net. Wt. 0.4 FL OZ (13 mL). UPC 3 10742 10909 2, Manufactured by Rohto-Mentholatum (Vietnam) Co., Ltd. for The Mentholatum Company, Orchard Park, NY 14127. Made in Vietnam.
- Affected lot / code info
- Stock No: 1090; Case UPC: 3 10742 91080 (2); Item UPC 3 10742 10909 2
Why it was 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.
Recalling firm
- Firm
- The Mentholatum Co.
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 707 Sterling Drive, Orchard Park, New York 14127
Distribution
- Quantity
- 59, 376 units Total (32,184 units held in stock, quarantined)
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2014-01-16
- FDA classified
- 2014-01-28
- Posted by FDA
- 2014-02-05
- Terminated
- 2018-06-01
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1037-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.