{
  "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": "2026-07-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Dublin",
      "state": "OH",
      "country": "United States",
      "classification": "Class I",
      "openfda": {
        "application_number": [
          "M018"
        ],
        "brand_name": [
          "DRY EYE RELIEF"
        ],
        "generic_name": [
          "POLYETHYLENE GLYCOL AND PROPYLENE GLYCOL"
        ],
        "manufacturer_name": [
          "CARDINAL HEALTH 110, LLC. DBA LEADER"
        ],
        "product_ndc": [
          "70000-0088"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "OPHTHALMIC"
        ],
        "substance_name": [
          "POLYETHYLENE GLYCOL 400",
          "PROPYLENE GLYCOL"
        ],
        "rxcui": [
          "895753"
        ],
        "spl_id": [
          "424cccfb-27a9-43c8-9793-34bc5ddcb882"
        ],
        "spl_set_id": [
          "f8da3af5-9172-4023-be82-0fd5bd891616"
        ],
        "package_ndc": [
          "70000-0088-1"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "B697894SGQ",
          "6DC9Q167V3"
        ]
      },
      "product_type": "Drugs",
      "event_id": "93346",
      "recalling_firm": "Cardinal Health Inc.",
      "address_1": "7000 Cardinal Pl",
      "address_2": "N/A",
      "postal_code": "43017-1091",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Press Release",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0135-2024",
      "product_description": "LEADER brand Dry Eye Relief (Polyethylene Glycol 400, 0.4% Propylene Glycol, 0.3%); 0.33 FL OZ (10 mL) dropper bottle, Sterile, Distributed By Cardinal Health, Dublin, Ohio 43017, Made in India NDC: 70000-0088-1",
      "product_quantity": "11,782 bottles",
      "reason_for_recall": "Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.",
      "recall_initiation_date": "20231031",
      "center_classification_date": "20231201",
      "report_date": "20231129",
      "code_info": "ALL LOTS",
      "more_code_info": ""
    }
  ]
}