{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-07-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Ho Chi Minh",
      "state": "N/A",
      "country": "Vietnam",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "M018"
        ],
        "brand_name": [
          "ROHTO"
        ],
        "generic_name": [
          "HYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATE"
        ],
        "manufacturer_name": [
          "The Mentholatum Company"
        ],
        "product_ndc": [
          "10742-8146"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "OPHTHALMIC"
        ],
        "substance_name": [
          "HYPROMELLOSE, UNSPECIFIED",
          "TETRAHYDROZOLINE HYDROCHLORIDE",
          "ZINC SULFATE, UNSPECIFIED FORM"
        ],
        "rxcui": [
          "1098640"
        ],
        "spl_id": [
          "53610d02-cacc-6819-e063-6294a90ab06e"
        ],
        "spl_set_id": [
          "43e690e4-b381-46e3-838c-33aef5bdadde"
        ],
        "package_ndc": [
          "10742-8146-1",
          "3107420108"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0310742010862",
          "310742010862"
        ],
        "unii": [
          "3NXW29V3WO",
          "0YZT43HS7D",
          "89DS0H96TB"
        ]
      },
      "product_type": "Drugs",
      "event_id": "99440",
      "recalling_firm": "Rohto-Mentholatum (Vietnam) Co., Ltd.",
      "address_1": "No. 16 Vsip, Street No. 5",
      "address_2": "Vietnam Singapore Industrial Park",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide within the United States",
      "recall_number": "D-0715-2026",
      "product_description": "Rohto Cooling Eye Drops ALL-IN-ONE (hypromellose 0.2%, tetrahydrozoline HCL 0.05%, zinc sulfate 0.25%), Sterile 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam UPC 310742010862, NDC 10742-8146-1",
      "product_quantity": "1.033,266 cartons",
      "reason_for_recall": "Lack of Assurance of Sterility",
      "recall_initiation_date": "20260714",
      "center_classification_date": "20260723",
      "report_date": "20260729",
      "code_info": "Lot #: 3H1V, Exp. Date 2026/07; 3J1V, 3J2V, Exp. Date 2026/09; 3K1V, Exp. Date 2026/10;  4A1V, 4A2V, Exp. Date 2026/12; 4B1V, 4B2V, Exp. Date 2027/01; 4G1V, 4G2V, 4G3V, Exp. Date 2027/06; 4I1V, 4I2V, 4I2VA Exp. Date 2027/08; 4J1V, 4J2V, Exp. Date 2027/09; 4K2V, 4K3V, 4K4V Exp. Date2027/10; 5B1V, 5B2V, 5B3V, Exp. Date 2028/01; 5D1V, Exp. Date 2028/03; 5E1V, 5E2V, 5E3V, Exp. Date 2028/04; 5H1V, Exp. Date 2028/07; 5I1V, Exp. Date 2028/08; 5J1V, 5J2V, Exp. Date 2028/09; 5L1V, 5L1VA, 5L1VB, 5L1VC, 5L1VD, 5L2V,Exp. Date 2028/11; 6A1V,  6A2V, Exp. Date 2028/12; 6B1V, Exp. Date 2029/01 & Lot 6C1V, Exp. Date 2029/02."
    }
  ]
}