{
  "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 DRY-AID"
        ],
        "generic_name": [
          "POVIDONE, PROPYLENE GLYCOL"
        ],
        "manufacturer_name": [
          "The Mentholatum Company"
        ],
        "product_ndc": [
          "10742-8162"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "OPHTHALMIC"
        ],
        "substance_name": [
          "POVIDONE, UNSPECIFIED",
          "PROPYLENE GLYCOL"
        ],
        "rxcui": [
          "1863574"
        ],
        "spl_id": [
          "297ac7ef-664e-b36e-e063-6394a90aa6b1"
        ],
        "spl_set_id": [
          "8ea5c6c9-48f4-406a-a2cb-9280c546d87d"
        ],
        "package_ndc": [
          "10742-8162-1",
          "10742-8162-2",
          "3107420111"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "FZ989GH94E",
          "6DC9Q167V3"
        ],
        "upc": [
          "310742011159"
        ]
      },
      "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-0721-2026",
      "product_description": "Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, TWIN PACK 0.34 FL OZ (10 mL) each, Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011159, NDC 10742-8162-2",
      "product_quantity": "353 cartons",
      "reason_for_recall": "Lack of Assurance of Sterility",
      "recall_initiation_date": "20260714",
      "center_classification_date": "20260723",
      "report_date": "20260729",
      "code_info": "Lot #: 4G1V, Exp 2027/06; 4J1V, 512VB 2027/09; 5D1V, 2028/03; 5G1V, 512VB 2028/06;  512V, 512VB 2028/08"
    }
  ]
}