Recall D-1037-2014
Description: 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.
Recall D-1037-2014 Information
| Status | Terminated |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1037-2014 |
| Event ID | 67314 |
| Distribution | Nationwide and Puerto Rico |
| Quantity | 59, 376 units Total (32,184 units held in stock, quarantined) |
| Recall 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. |
| Drug Classification | Class II |
| Drug Code Info | 20140205 |
| Recall Initiation Date | 20140116 |
| Report Date | 20140205 |
| Termination Date | 20180601 |
| Classification Date | 20140128 |
| Address | 707 Sterling Drive Orchard Park, NY 14127 United States |
| Recalling Firm | The Mentholatum Co. |
| Initial Notification | Press Release |
| Similar To |