{
  "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,
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    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Navi Mumbai",
      "state": "",
      "country": "India",
      "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": [
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        "substance_name": [
          "POLYETHYLENE GLYCOL 400",
          "PROPYLENE GLYCOL"
        ],
        "rxcui": [
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        "spl_id": [
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        "package_ndc": [
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        "is_original_packager": [
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        ],
        "unii": [
          "B697894SGQ",
          "6DC9Q167V3"
        ]
      },
      "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-0295-2024",
      "product_description": "Leader brand Dry Eye Relief (Polyethylene glycol 400 0.4% and Propylene glycol 0.3%) packaged in 0.33 FL OZ (10 mL) bottles, Distributed by Cardinal Health Dublin, Ohio 43017, NDC 70000-0088-1",
      "product_quantity": "12,960 bottles",
      "reason_for_recall": "Non-Sterility",
      "recall_initiation_date": "20231113",
      "center_classification_date": "20240205",
      "report_date": "20240214",
      "code_info": "All lots",
      "more_code_info": ""
    }
  ]
}