Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, 0.34 FL OZ (10 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011135, NDC 10742-8162-1
USRohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, 0.34 FL OZ (10 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011135, NDC 10742-8162-1
Recalling Firm: Rohto-Mentholatum (Vietnam) Co., Ltd.
Reason for Recall / Hazard
Lack of Assurance of Sterility
Product Description & Identification
Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, 0.34 FL OZ (10 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011135, NDC 10742-8162-1
Additional Source Details
| Field | Value |
|---|---|
| City | Ho Chi Minh |
| State | N/A |
| Openfda › Upc | 310742011135 |
| Openfda › Unii › 1 | FZ989GH94E |
| Openfda › Unii › 2 | 6DC9Q167V3 |
| Openfda › Route | OPHTHALMIC |
| Openfda › Rxcui | 1863574 |
| Openfda › Spl id | 297ac7ef-664e-b36e-e063-6394a90aa6b1 |
| Openfda › Brand name | ROHTO DRY-AID |
| Openfda › Spl set id | 8ea5c6c9-48f4-406a-a2cb-9280c546d87d |
| Openfda › Package ndc › 1 | 10742-8162-1 |
| Openfda › Package ndc › 2 | 10742-8162-2 |
| Openfda › Package ndc › 3 | 3107420111 |
| Openfda › Product ndc | 10742-8162 |
| Openfda › Generic name | POVIDONE, PROPYLENE GLYCOL |
| Openfda › Product type | HUMAN OTC DRUG |
| Openfda › Substance name › 1 | POVIDONE, UNSPECIFIED |
| Openfda › Substance name › 2 | PROPYLENE GLYCOL |
| Openfda › Manufacturer name | The Mentholatum Company |
| Openfda › Application number | M018 |
| Openfda › Is original packager | true |
| Event id | 99440 |
| Address 1 | No. 16 Vsip, Street No. 5 |
| Address 2 | Vietnam Singapore Industrial Park |
| Code info | Lot #: 4G1VA, Exp. Date 2027/06; 4J1VA, Exp. Date 2027/09; 5A1V, Exp. Date 2027/12; 5D1VA, Exp. Date 2028/03; 5G1VA, Exp. Date 2028/06; 512V, 512V, 512VB Exp. Date 2028/08; 5L2VA, 512VB 2028/11. |
| Postal code | N/A |
| Report date | 20260729 |
| Product type | Drugs |
| Product quantity | 97201 cartons |
| Reason for recall | Lack of Assurance of Sterility |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260714 |
| Initial firm notification | Letter |
| Center classification date | 20260723 |
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Overview
- Recalling FirmRohto-Mentholatum (Vietnam) Co., Ltd.
- StatusOngoing
- Risk LevelClass II
- DistributionNationwide within the United States
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🚨 SAFETY ALERT: Rohto-Mentholatum (Vietnam) Co., Ltd. - Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, 0.34 FL OZ (10 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011135, NDC 10742-8162-1 Check if your household is affected: https://therecallfile.com/recalls/rohto-cooling-eye-drops-dry-aid-povidone-0-68-propylene-glycol-0-3-ste/FDA-D-0720-2026
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