{
  "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": "2026-10-14",
    "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 NEIGHBOR PHARMACY ARTIFICAL TEARS LUBRICANT EYE DROPS",
          "GOOD SENSE ARTIFICIAL TEARS",
          "ARTIFICIAL TEARS",
          "QUALITY CHOICE ARTIFICIAL TEARS LUBRICANT EYE DROPS"
        ],
        "generic_name": [
          "POLYVINYL ALCOHOL, POVIDONE"
        ],
        "manufacturer_name": [
          "Cardinal Health",
          "AmerisourceBergen",
          "Geiss, Destin & Dunn, Inc.",
          "KC Pharmaceuticals, Inc.",
          "Chain Drug Marketing Association, Inc."
        ],
        "product_ndc": [
          "70000-0011",
          "24385-006",
          "50804-110",
          "55651-008",
          "83324-189"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "OPHTHALMIC"
        ],
        "substance_name": [
          "POLYVINYL ALCOHOL, UNSPECIFIED",
          "POVIDONE",
          "POVIDONE, UNSPECIFIED",
          "POLYVINYL ALCOHOL"
        ],
        "rxcui": [
          "598050"
        ],
        "spl_id": [
          "5b120e34-0a0e-e1ae-e063-6294a90a15bc",
          "5739a45b-5bf7-5db8-e063-6394a90a7ffc",
          "47450941-e9fd-623c-e063-6294a90a940b",
          "4748d0f4-e97c-a0c1-e063-6394a90ac311",
          "47494778-349f-6448-e063-6294a90a3c34"
        ],
        "spl_set_id": [
          "8cccc589-3a8e-baad-e053-2a95a90ab8c7",
          "ce6852a8-c5e6-403d-a7b4-a2e85d1ebb1f",
          "9b243301-2e4b-5706-e053-2995a90a9b90",
          "eb6eb6c4-1609-407b-84e4-c7509811f3c0",
          "1f669655-4bc7-0175-e063-6294a90a305a"
        ],
        "package_ndc": [
          "70000-0011-1",
          "24385-006-05",
          "50804-110-01",
          "55651-008-01",
          "83324-189-14"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0096295137644",
          "0087701104060",
          "0180410000163",
          "0095072015519",
          "0635515992238",
          "070038470083",
          "041415009769",
          "036800093317",
          "311917065038",
          "011110386007"
        ],
        "unii": [
          "532B59J990",
          "FZ989GH94E"
        ]
      },
      "product_type": "Drugs",
      "event_id": "99880",
      "recalling_firm": "K.C. Pharmaceuticals, Inc.",
      "address_1": "3420 Pomona Blvd",
      "address_2": "N/A",
      "postal_code": "91768-3236",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "US Nationwide",
      "recall_number": "D-0002-2027",
      "product_description": "Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5%, povidone 0.6%), 0.5 FL OZ (15 mL) bottles; a) Best Choice, PROUDLY DISTRIBUTED BY: VALU MERCHANDISERS, CO., 5000 KANSAS CITY, KS 66106, UPC 0 70038 47008 3; b) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0011-1; c) Good Neighbor Pharmacy, Distributed By AmerisourceBergen, 1 West First Avenue, Conshohocken, PA 19428, NDC 24385-006-05; d) Good Sense, Distributed By: Geiss, Destin& Dunn, Inc., A Perrigo Company, Peachtree City, GA 30269, NDC 50804-110-01; e) Medic'c Choice, Sterile 0.5 fl. oz. (15 mL), Manufactured by KC Pharmaceuticals, Inc., Pomona, CA 91768, NDC 55651-008-01; f) P, DISTRIBUTED BY PUBLIX SUPER MARKETS, INC, LAKELAND, FL 33811, UPC 0 41415 00976 9; g) Quality Choice, Distributed by CDMA Inc, Novi, MI NDC 83324-189-14; h) TopCare health, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELKGROVE VILLAGE, IL 60007, UPC 0 36800 09331 7; I) Walgreens, DISTRIBUTED BY: WALGREEN CO. DEERFIELD, IL 60015, UPC 3 11917 06503 8; J) Kroger, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202, UPC 0 11110 38600 7.",
      "product_quantity": "505,896 cartons",
      "reason_for_recall": "Lack of Assurance of Sterility",
      "recall_initiation_date": "20260911",
      "center_classification_date": "20261005",
      "report_date": "20261014",
      "code_info": "Lot: a) AT25B01, Exp.: 2/28/2027; b) AT24N01, Exp.: 11/30/2026; AT25B01, Exp.: 2/28/2027; AT25D01, Exp.: 04/30/27; AT25F01, Exp.: 6/30/2027; AT25F02, Exp.: 6/30/2027; AT25K02, Exp.: 9/30/2027; c) AT25D01, Exp.: 04/30/27; AT25K02, Exp.: 9/30/2027; d) AT24N01, Exp.: 11/30/2026; AT25B01, Exp.: 2/28/2027; AT25D01, Exp.: 04/30/27; AT25F01, Exp.: 6/30/2027; AT25F02, Exp.: 6/30/2027; AT25K01, Exp.: 9/30/2027; AT25K02, Exp.: 9/30/2027; e) AT25B01, Exp.: 2/28/2027; f) AT25B01, Exp.: 2/28/2027;  AT25D01, Exp.: 04/30/27; g) AT25B01, Exp.: 2/28/2027; AT25F02, Exp.: 6/30/2027;  AT25K01, Exp.: 9/30/2027; h) AT25B01, Exp.: 2/28/2027; AT25D01, Exp.: 04/30/27; I) AT25D01, Exp.: 04/30/27; AT25F01, Exp.: 6/30/2027; AT25K02, Exp.: 9/30/2027; J) AT24N01, Exp.: 11/30/2026."
    }
  ]
}