{
  "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": "2026-04-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Pomona",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "M018"
        ],
        "brand_name": [
          "LEADER ARTIFICIAL TEARS 15 ML",
          "GOOD SENSE ARTIFICIAL TEARS",
          "GOOD NEIGHBOR PHARMACY ARTIFICAL TEARS LUBRICANT EYE DROPS",
          "QUALITY CHOICE ARTIFICIAL TEARS LUBRICANT EYE DROPS"
        ],
        "generic_name": [
          "POLYVINYL ALCOHOL, POVIDONE"
        ],
        "manufacturer_name": [
          "Cardinal Health",
          "Geiss, Destin & Dunn, Inc.",
          "AmerisourceBergen",
          "Chain Drug Marketing Association, Inc."
        ],
        "product_ndc": [
          "70000-0011",
          "50804-110",
          "24385-006",
          "83324-189"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "OPHTHALMIC"
        ],
        "substance_name": [
          "POLYVINYL ALCOHOL, UNSPECIFIED",
          "POVIDONE",
          "POLYVINYL ALCOHOL"
        ],
        "rxcui": [
          "598050"
        ],
        "spl_id": [
          "0d376274-1a79-5fbc-e063-6394a90a2cf2",
          "47450941-e9fd-623c-e063-6294a90a940b",
          "0cfa48cc-26b5-c528-e063-6394a90a3aa9",
          "47494778-349f-6448-e063-6294a90a3c34"
        ],
        "spl_set_id": [
          "8cccc589-3a8e-baad-e053-2a95a90ab8c7",
          "9b243301-2e4b-5706-e053-2995a90a9b90",
          "ce6852a8-c5e6-403d-a7b4-a2e85d1ebb1f",
          "1f669655-4bc7-0175-e063-6294a90a305a"
        ],
        "package_ndc": [
          "70000-0011-1",
          "50804-110-01",
          "24385-006-05",
          "83324-189-14"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0096295137644",
          "0180410000163",
          "0087701104060",
          "0635515992238",
          "036800093317",
          "070038470083",
          "011110386007",
          "041415009769"
        ],
        "unii": [
          "532B59J990",
          "FZ989GH94E"
        ]
      },
      "product_type": "Drugs",
      "event_id": "98533",
      "recalling_firm": "K.C. Pharmaceuticals, Inc",
      "address_1": "3420 Pomona Blvd",
      "address_2": "",
      "postal_code": "91768-3236",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "Nationwide in the US",
      "recall_number": "D-0416-2026",
      "product_description": "Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5%, povidone 0.6%), 0.5 FL OZ (15 mL) bottles; a) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0011-1; b) Good Sense, Distributed By: Perrigo Direct, Inc., Peachtree City, GA 30269, www.PerrigoDirect.com, NDC 50804-110-01; c) Good Neighbor Pharmacy, Distributed By AmerisourceBergen, Conshohocken, PA 19428, NDC 24385-006-05; d) TopCare health, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELKGROVE VILLAGE, IL 60007, UPC 0 36800 09331 7; e) Best Choice, PROUDLY DISTRIBUTED BY: VALU MERCHANDISERS, CO., KANSAS CITY, KS 66106, UPC 0 70038 47008 3; f) Kroger, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202, UPC 0 11110 38600 7; g) P, DISTRIBUTED BY PUBLIX SUPER MARKETS, INC, LAKELAND, FL 33811, UPC 0 41415 00976 9; h) Quality Choice, Distributed by CDMA Inc, Novi, MI NDC 83324-189-14",
      "product_quantity": "589,848 bottles",
      "reason_for_recall": "Lack of Assurance of Sterility",
      "recall_initiation_date": "20260303",
      "center_classification_date": "20260331",
      "report_date": "20260408",
      "code_info": "Lot: a) AT24D01, Exp.: 04/30/26; AT24E01, Exp.: 05/31/26; AT24G01, Exp.: 07/31/26; b) AT24D01, Exp.: 04/30/26; AT24E01, AT24E02, Exp.: 05/31/26; AT24G01, Exp.: 07/31/26; c) AT24D01, Exp.: 04/30/26; AT24E01, Exp.: 05/31/26; AT24G01, Exp.: 07/31/26; d) AT24D01, Exp.: 04/30/26; AT24E01, AT24E02, Exp.: 05/31/26; AT24G01, Exp.: 07/31/26; e) AT24E01, Exp.: 05/31/26; AT24G01, Exp.: 07/31/26; f) AT24E01, AT24E02, Exp.: 05/31/26; AT24G01, Exp.: 07/31/26; g) AT24E02, Exp.: 05/31/26.",
      "more_code_info": ""
    }
  ]
}