{
  "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": [
          "310742011135"
        ]
      },
      "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-0720-2026",
      "product_description": "Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, 0.34 FL OZ (10 mL), Distributed by: The Mentholatum Company, Orchard Park, NY 14127, Made in Vietnam, UPC 310742011135, NDC 10742-8162-1",
      "product_quantity": "97201 cartons",
      "reason_for_recall": "Lack of Assurance of Sterility",
      "recall_initiation_date": "20260714",
      "center_classification_date": "20260723",
      "report_date": "20260729",
      "code_info": "Lot #: 4G1VA, Exp. Date 2027/06; 4J1VA, Exp. Date 2027/09;  5A1V, Exp. Date 2027/12;  5D1VA, Exp. Date 2028/03; 5G1VA, Exp. Date 2028/06; 512V, 512V, 512VB Exp. Date 2028/08; 5L2VA, 512VB 2028/11."
    }
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}