{
  "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 DIGI-EYE"
        ],
        "generic_name": [
          "HYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "The Mentholatum Company"
        ],
        "product_ndc": [
          "10742-8175"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "OPHTHALMIC"
        ],
        "substance_name": [
          "HYPROMELLOSE, UNSPECIFIED",
          "TETRAHYDROZOLINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1098644"
        ],
        "spl_id": [
          "5363969d-75c3-8036-e063-6394a90ae420"
        ],
        "spl_set_id": [
          "5d6f37b9-b568-4cb6-92de-eb40779f3f8c"
        ],
        "package_ndc": [
          "10742-8175-1",
          "3107420106"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "3NXW29V3WO",
          "0YZT43HS7D"
        ],
        "upc": [
          "310742010602"
        ]
      },
      "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-0719-2026",
      "product_description": "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",
      "product_quantity": "65219 cartons",
      "reason_for_recall": "Lack of Assurance of Sterility",
      "recall_initiation_date": "20260714",
      "center_classification_date": "20260723",
      "report_date": "20260729",
      "code_info": "Lot #: 4B1V, 4B1VA, Exp. Date 2027/01; 4J1V, Exp. Date 2027/09"
    }
  ]
}