{
  "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 ULTRA LUBRICATING EYE DROPS",
          "GOODSENSE ULTRA LUBRICANT EYE DROPS"
        ],
        "generic_name": [
          "POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL"
        ],
        "manufacturer_name": [
          "Cardinal Health",
          "Geiss, Destin & Dunn, Inc."
        ],
        "product_ndc": [
          "70000-0457",
          "50804-160"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "OPHTHALMIC"
        ],
        "substance_name": [
          "POLYETHYLENE GLYCOL 400",
          "PROPYLENE GLYCOL"
        ],
        "rxcui": [
          "477589"
        ],
        "spl_id": [
          "4ccccdc5-a8f7-6d26-e063-6394a90a8795",
          "474511c4-1fbd-70b8-e063-6294a90af8e8"
        ],
        "spl_set_id": [
          "d7f011a2-05ba-47c3-9519-d31602e105c7",
          "9b45ebb5-c43b-c9fb-e053-2a95a90a3411"
        ],
        "package_ndc": [
          "70000-0457-1",
          "70000-0457-2",
          "50804-160-01",
          "1429905619"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0096295137101",
          "0846036008210",
          "614299056190",
          "311917201672"
        ],
        "unii": [
          "B697894SGQ",
          "6DC9Q167V3"
        ]
      },
      "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-0009-2027",
      "product_description": "Sterile High Performance Ultra Lubricating Eye Drops (Polyethylene Glycol 400, 0.4%   Relieves Dry and Irritated Eyes) Product size: 0.5 fl oz (15 mL); a) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0457-1; b) exchange select, Manufactured for your Military Exchange By: K.C Pharmaceuticals, Inc., Pomona, CA 9176, UPC: 6 1429905619 0; c) Good Sense, Distributed By: Perrigo Direct Inc., Peachtree City, GA 30269, NDC 50804-160-01; d) Walgreens, DISTRIBUTED BY: WALGREEN CO., 200 WILMOT RD, DEERFIELD, IL 60015, UPC 3 11917 20167 2.",
      "product_quantity": "163,008 cartons",
      "reason_for_recall": "Lack of Assurance of Sterility",
      "recall_initiation_date": "20260911",
      "center_classification_date": "20261005",
      "report_date": "20261014",
      "code_info": "Lot: a) SU25B01, Exp.: 02/28/2027; b) SU25N01, Exp.: 11/30/2027; c) SU25B01, Exp.: 02/28/2027; SU25N01, Exp.: 11/30/2027; SU25N02, Exp.: 11/30/2027; d) SU25B01, Exp.: 02/28/2027."
    }
  ]
}