{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Navi Mumbai",
      "state": "",
      "country": "India",
      "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": "93357",
      "recalling_firm": "Kilitch Healthcare India Limited",
      "address_1": "R - 904 905 T T C Industrial Road",
      "address_2": "",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Press Release",
      "distribution_pattern": "Nationwide within the United States",
      "recall_number": "D-0291-2024",
      "product_description": "Leader brand Lubricant Eye Drops (Carboxymethylcellulose Sodium 0.5%), packaged in a) 0.5 FL OZ (15mL) bottles (Single Pack)  (NDC 70000-0090-1) and b) 0.5 FL OZ (15 mL) bottles (Twin pack) (NDC 70000-0090-2), Distributed by: Cardinal Health Dublin, Ohio 43017",
      "product_quantity": "210,192 bottles",
      "reason_for_recall": "Non-Sterility",
      "recall_initiation_date": "20231113",
      "center_classification_date": "20240205",
      "report_date": "20240214",
      "code_info": "All lots",
      "more_code_info": ""
    }
  ]
}