Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 80 0.2%), Sterile, TWIN PACK, 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011210, NDC 10742-8158-2
USRohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 80 0.2%), Sterile, TWIN PACK, 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011210, NDC 10742-8158-2
Recalling Firm: Rohto-Mentholatum (Vietnam) Co., Ltd.
Reason for Recall / Hazard
Lack of Assurance of Sterility
Product Description & Identification
Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 80 0.2%), Sterile, TWIN PACK, 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011210, NDC 10742-8158-2
Additional Source Details
| Field | Value |
|---|---|
| City | Ho Chi Minh |
| State | N/A |
| Openfda › Upc › 1 | 0310742011012 |
| Openfda › Upc › 2 | 310742011210 |
| Openfda › Unii › 1 | MZ1131787D |
| Openfda › Unii › 2 | 6OZP39ZG8H |
| Openfda › Route | OPHTHALMIC |
| Openfda › Rxcui | 1535485 |
| Openfda › Spl id | 53616875-c5b9-f20c-e063-6394a90a12d5 |
| Openfda › Brand name | ROHTO |
| Openfda › Spl set id | e4b49550-1ca3-4bd7-854d-409b53fa5e26 |
| Openfda › Package ndc › 1 | 10742-8158-1 |
| Openfda › Package ndc › 2 | 10742-8158-2 |
| Openfda › Package ndc › 3 | 3107420112 |
| Openfda › Product ndc | 10742-8158 |
| Openfda › Generic name | NAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80 |
| Openfda › Product type | HUMAN OTC DRUG |
| Openfda › Substance name › 1 | NAPHAZOLINE HYDROCHLORIDE |
| Openfda › Substance name › 2 | POLYSORBATE 80 |
| 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 #: 3H1V, Exp. Date2026/07; 3J2V, Exp. Date 2026/09; 4A1V, 4A1VA, Exp. Date 2026/12; 4G1V, Exp. Date 2027/06; 4I3V, Exp. Date 2027/08; 5A1V, Exp. Date 2027/12; 5B3V, Exp. Date2028/01; 5G3V, Exp. Date 2028/06; 5J1V, Exp. Date 2028/09; 5L1V, Exp. Date 2028/11; 6A1V, Exp. Date 2028/12; 6B4V, Exp. Date 2029/01; 6C2V, Exp. Date 2029/02. |
| Postal code | N/A |
| Report date | 20260729 |
| Product type | Drugs |
| Product quantity | 499,673 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 Max Strength (naphazoline hydrochloride 0.03%, polysorbate 80 0.2%), Sterile, TWIN PACK, 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011210, NDC 10742-8158-2 Check if your household is affected: https://therecallfile.com/recalls/rohto-cooling-eye-drops-max-strength-naphazoline-hydrochloride-0-03-po/FDA-D-0717-2026
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