{
  "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": [
          "LUBRICANT DROPS"
        ],
        "generic_name": [
          "CARBOXYMETHYLCELLULOSE SODIUM"
        ],
        "manufacturer_name": [
          "CARDINAL HEALTH 110, LLC. DBA LEADER"
        ],
        "product_ndc": [
          "70000-0090"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "OPHTHALMIC"
        ],
        "substance_name": [
          "CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED"
        ],
        "rxcui": [
          "1188426"
        ],
        "spl_id": [
          "7032f298-3bfe-4fd2-b240-36ec6015ffbe"
        ],
        "spl_set_id": [
          "1ac2fe24-9ff6-48c1-b123-fbc0e48f5304"
        ],
        "package_ndc": [
          "70000-0090-1",
          "70000-0090-2"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "K679OBS311"
        ]
      },
      "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-0134-2024",
      "product_description": "LEADER brand Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%); 2 bottles, 0.5 FL OZ (15 mL) dropper bottles, Sterile, Distributed By Cardinal Health, Dublin, Ohio 43017,  Made in India NDC:70000-0090-2 (Carton); 70000-0090-1 (Bottle)",
      "product_quantity": "28477 cartons",
      "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": ""
    }
  ]
}