{
  "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": "Navi Mumbai",
      "state": "",
      "country": "India",
      "classification": "Class I",
      "openfda": {
        "application_number": [
          "M018"
        ],
        "brand_name": [
          "EYES IRRITATION RELIEF"
        ],
        "generic_name": [
          "POLYVINYL ALCOHOL AND POVIDONE AND TETRAHYDROZOLINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "CARDINAL HEALTH 110, LLC. DBA LEADER"
        ],
        "product_ndc": [
          "70000-0087"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "OPHTHALMIC"
        ],
        "substance_name": [
          "POLYVINYL ALCOHOL, UNSPECIFIED",
          "POVIDONE, UNSPECIFIED",
          "TETRAHYDROZOLINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1235569"
        ],
        "spl_id": [
          "aaaabf8c-8ca5-4fe3-8e21-ba270c7f3991"
        ],
        "spl_set_id": [
          "bd2608c6-ffdf-352a-e053-2995a90a26a8"
        ],
        "package_ndc": [
          "70000-0087-1"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "532B59J990",
          "FZ989GH94E",
          "0YZT43HS7D"
        ]
      },
      "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-0297-2024",
      "product_description": "Leader brand Eye Irritation Relief (Polyvinyl alcohol 0.5%, Povidone 0.6%, Tetrahydrozoline 0.05%), packaged in 0.5 FL OZ (15 mL) bottles, Cardinal Health Dublin, Ohio 43017, NDC 70000-0087-1",
      "product_quantity": "10,944 bottles",
      "reason_for_recall": "Non-Sterility",
      "recall_initiation_date": "20231113",
      "center_classification_date": "20240205",
      "report_date": "20240214",
      "code_info": "All lots",
      "more_code_info": ""
    }
  ]
}