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.
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.
Lot numbers, UPCs & expiration codes
Stock No: 1086; Case UPC: 3 10742 91086 (5); Item UPC 3 10742 01086 2
Where it was sold
Nationwide and Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1038-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 16, 2014
- FDA report date
- Feb 5, 2014
- Quantity
- 94,080 units Total (432 units held in stock, quarantined)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- The Mentholatum Co.
Original FDA data
Every field from FDA enforcement report D-1038-2014, exactly as published.
Show all FDA fields
- City
- Orchard Park
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 67314
- Address
- 707 Sterling Drive
- Code information
- Stock No: 1086; Case UPC: 3 10742 91086 (5); Item UPC 3 10742 01086 2
- Postal code
- 14127
- Report date
- Feb 5, 2014
- Product type
- Drugs
- Recall number
- D-1038-2014
- Classification
- Class II
- Recalling firm
- The Mentholatum Co.
- Product quantity
- 94,080 units Total (432 units held in stock, quarantined)
- Termination date
- Jun 1, 2018
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Jan 16, 2014
- Initial firm notification
- Press Release
- Center classification date
- Jan 28, 2014