Rohto Cooling Eye Drops Digi Eye (hypromellose 0.35%, tetrahydrozoline HCl 0.05%), Sterile, 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742010602, NDC 10742-8175-1
USRohto Cooling Eye Drops Digi Eye (hypromellose 0.35%, tetrahydrozoline HCl 0.05%), Sterile, 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742010602, NDC 10742-8175-1
Recalling Firm: Rohto-Mentholatum (Vietnam) Co., Ltd.
Reason for Recall / Hazard
Lack of Assurance of Sterility
Product Description & Identification
Rohto Cooling Eye Drops Digi Eye (hypromellose 0.35%, tetrahydrozoline HCl 0.05%), Sterile, 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742010602, NDC 10742-8175-1
Additional Source Details
| Field | Value |
|---|---|
| City | Ho Chi Minh |
| State | N/A |
| Openfda › Upc | 310742010602 |
| Openfda › Unii › 1 | 3NXW29V3WO |
| Openfda › Unii › 2 | 0YZT43HS7D |
| Openfda › Route | OPHTHALMIC |
| Openfda › Rxcui | 1098644 |
| Openfda › Spl id | 5363969d-75c3-8036-e063-6394a90ae420 |
| Openfda › Brand name | ROHTO DIGI-EYE |
| Openfda › Spl set id | 5d6f37b9-b568-4cb6-92de-eb40779f3f8c |
| Openfda › Package ndc › 1 | 10742-8175-1 |
| Openfda › Package ndc › 2 | 3107420106 |
| Openfda › Product ndc | 10742-8175 |
| Openfda › Generic name | HYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE |
| Openfda › Product type | HUMAN OTC DRUG |
| Openfda › Substance name › 1 | HYPROMELLOSE, UNSPECIFIED |
| Openfda › Substance name › 2 | TETRAHYDROZOLINE HYDROCHLORIDE |
| 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 #: 4B1V, 4B1VA, Exp. Date 2027/01; 4J1V, Exp. Date 2027/09 |
| Postal code | N/A |
| Report date | 20260729 |
| Product type | Drugs |
| Product quantity | 65219 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 Digi Eye (hypromellose 0.35%, tetrahydrozoline HCl 0.05%), Sterile, 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742010602, NDC 10742-8175-1 Check if your household is affected: https://therecallfile.com/recalls/rohto-cooling-eye-drops-digi-eye-hypromellose-0-35-tetrahydrozoline-hc/FDA-D-0719-2026
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