Rohto Cooling Eye Drops Cool Relief (naphazoline hydrochloride 0.012%, polysorbate 80 0.2%), Sterile, 0.4 FL OZ (13 mL) each, Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742010749, NDC 10742-8141-1
USRohto Cooling Eye Drops Cool Relief (naphazoline hydrochloride 0.012%, polysorbate 80 0.2%), Sterile, 0.4 FL OZ (13 mL) each, Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742010749, NDC 10742-8141-1
Recalling Firm: Rohto-Mentholatum (Vietnam) Co., Ltd.
Reason for Recall / Hazard
Lack of Assurance of Sterility
Product Description & Identification
Rohto Cooling Eye Drops Cool Relief (naphazoline hydrochloride 0.012%, polysorbate 80 0.2%), Sterile, 0.4 FL OZ (13 mL) each, Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742010749, NDC 10742-8141-1
Additional Source Details
| Field | Value |
|---|---|
| City | Ho Chi Minh |
| State | N/A |
| Openfda › Upc › 1 | 0310742010749 |
| Openfda › Upc › 2 | 310742010749 |
| Openfda › Unii › 1 | MZ1131787D |
| Openfda › Unii › 2 | 6OZP39ZG8H |
| Openfda › Route | OPHTHALMIC |
| Openfda › Rxcui | 1098362 |
| Openfda › Spl id | 54a037ff-1157-92f5-e063-6294a90a4de0 |
| Openfda › Brand name | ROHTO |
| Openfda › Spl set id | dc8f1ff3-87ae-47ca-815f-5a0e34f8cf30 |
| Openfda › Package ndc › 1 | 10742-8141-1 |
| Openfda › Package ndc › 2 | 3107420107 |
| Openfda › Product ndc | 10742-8141 |
| 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 #: 3J1V, Exp. Date 2026/09; 4A1V, Exp. Date 2026/12; 4G1V, 4G2V, Exp. Date 2027/06; 4I1V, Exp. Date 2027/08; 4JIV, Exp. Date 2027/09; 5A1V, Exp. Date 2027/12 ; 5B1V, Exp. Date 2028/01; 5F1V, Exp. Date 2028/05; 5F1VA, Exp. Date 2028/05; 5H1V & 5H1VA, Exp. Date 2028/07; 5J1V, 5J1VA, Exp. Date 2028/09; 5L1V, Exp. Date 2028/11; 6B1V, Exp. Date 2029/01. |
| Postal code | N/A |
| Report date | 20260729 |
| Product type | Drugs |
| Product quantity | 2910148 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 Cool Relief (naphazoline hydrochloride 0.012%, polysorbate 80 0.2%), Sterile, 0.4 FL OZ (13 mL) each, Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742010749, NDC 10742-8141-1 Check if your household is affected: https://therecallfile.com/recalls/rohto-cooling-eye-drops-cool-relief-naphazoline-hydrochloride-0-012-po/FDA-D-0722-2026
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