{
  "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": [
          "NAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80"
        ],
        "manufacturer_name": [
          "The Mentholatum Company"
        ],
        "product_ndc": [
          "10742-8158"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "OPHTHALMIC"
        ],
        "substance_name": [
          "NAPHAZOLINE HYDROCHLORIDE",
          "POLYSORBATE 80"
        ],
        "rxcui": [
          "1535485"
        ],
        "spl_id": [
          "53616875-c5b9-f20c-e063-6394a90a12d5"
        ],
        "spl_set_id": [
          "e4b49550-1ca3-4bd7-854d-409b53fa5e26"
        ],
        "package_ndc": [
          "10742-8158-1",
          "10742-8158-2",
          "3107420110"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0310742011012",
          "310742011012"
        ],
        "unii": [
          "MZ1131787D",
          "6OZP39ZG8H"
        ]
      },
      "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-0716-2026",
      "product_description": "Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polysorbate 90, 0.2%), Sterile 0.4 FL OZ (13 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127,  Made in Vietnam, UPC 310742011012,  NDC 10742-8158-1",
      "product_quantity": "6076306 cartons",
      "reason_for_recall": "Lack of Assurance of Sterility",
      "recall_initiation_date": "20260714",
      "center_classification_date": "20260723",
      "report_date": "20260729",
      "code_info": "Lot #: 3H2V, 3H3V, Exp. Date 2026/07; 3J1V,  3J3V, 3J4V, 3J5V, Exp. Date 2026/09; 3K1V, 3K2V, Exp. Date 2026/10; 4A2V, Exp. Date 2026/12; 4B1V, 4B2V, 4B3V, Exp. Date 2027/01; 4F1V, 4F2V, 4F2V, 4F3V, 4F4V, Exp. Date 2027/05; 4G2V, 4G3V, 4G4V, 4G5V, Exp. Date 2027/06; 4H1V, Exp. Date 2027/07; 4I1V, 4I2V, 4I4V, 4I5V, Exp. Date 2027/08."
    }
  ]
}