FDA Drug recall D-1040-2014
ROHTO Cooling Eye Drops, Itch Relief, Soothes Itch & Burn, relief, Astringent, Lubricant, Redness Reliever Eye Drops, Sterile, Net
- FDA Drug
- Class II
- terminated
- Published 2014-02-05
On 2014-02-05 the FDA classified a Class II recall of ROHTO Cooling Eye Drops, Itch Relief, Soothes Itch & Burn, relief, Astringent, Lubricant, Redness Reliever Eye Drops, Sterile, Net by The Mentholatum, citing 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 qu….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1040-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-01-16 |
| Published | 2014-02-05 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | The Mentholatum |
| Distribution | US |
Product
ROHTO Cooling Eye Drops, Itch Relief, Soothes Itch & Burn, relief, Astringent, Lubricant, Redness Reliever Eye Drops, Sterile, Net. Wt. 0.4 FL OZ (13 mL). UPC 3 10742 01099 2, Manufactured by Rohto-Mentholatum (Vietnam) Co., Ltd. for The Mentholatum Company, Orchard Park, NY 14127. Made in Vietnam.
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.
Identifiers
| upc | 310742010992 |
|---|---|
| upc | 31074291099 |
| code_info | Stock No: 1099; Case UPC: 3 10742 91099 (5); Item UPC 3 10742 01099 2 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1040-2014%22
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