{
  "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 ADVANCED RELIEF EYE DROPS",
          "GOODSENSE EYE DROPS ADVANCED RELIEF MOISTURIZER",
          "MEDICS CHOICE EYE DROPS ADVANCED",
          "FOSTER AND THRIVE ADVANCED RELIEF EYE DROPS",
          "QUALITY CHOICE MOISTURIZING RELIEF EYE DROPS"
        ],
        "generic_name": [
          "DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL",
          "DEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL",
          "TETRAHYDROZOLINE HYDROCHLORIDE, POLYETHYLENE GLYCOL 400, DEXTRAN 70, POVIDONE",
          "POLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL"
        ],
        "manufacturer_name": [
          "Cardinal Health",
          "Geiss, Derstin & Dunn, Inc.",
          "KC Pharmaceuticals, Inc.",
          "Strategic Sourcing Services LLC",
          "Chain Drug Marketing Association, Inc."
        ],
        "product_ndc": [
          "70000-0456",
          "50804-130",
          "55651-025",
          "70677-1158",
          "83324-191"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "OPHTHALMIC"
        ],
        "substance_name": [
          "DEXTRAN 70",
          "POLYETHYLENE GLYCOL 400",
          "POVIDONE",
          "TETRAHYDROZOLINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "996202",
          "996209"
        ],
        "spl_id": [
          "4ccce313-8eec-8a62-e063-6394a90aa128",
          "47450d1c-db32-92cd-e063-6394a90a0703",
          "4748d5b2-f2f1-e88b-e063-6394a90af39a",
          "474922b2-773c-4cff-e063-6394a90a6b3a",
          "4749597d-57d8-92b6-e063-6294a90ab574"
        ],
        "spl_set_id": [
          "5c5d6c13-9b51-48f0-8627-b60b0f707fd3",
          "9b34de99-13df-201a-e053-2a95a90ae559",
          "ab906fd8-265c-4359-a920-d626366e245c",
          "0019cd99-b245-2ffc-e063-6294a90a9f27",
          "1fb81759-5931-59c8-e063-6294a90a2277"
        ],
        "package_ndc": [
          "70000-0456-1",
          "50804-130-01",
          "55651-025-01",
          "70677-1158-1",
          "83324-191-14"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0096295136470",
          "0180410000194",
          "0095072012518",
          "0010939958273",
          "0635515903760",
          "041163253926",
          "041220437450",
          "184125000180",
          "041415067769",
          "036800036413"
        ],
        "nui": [
          "N0000184175",
          "N0000009361",
          "N0000010288"
        ],
        "pharm_class_epc": [
          "Plasma Volume Expander [EPC]"
        ],
        "pharm_class_pe": [
          "Increased Intravascular Volume [PE]"
        ],
        "pharm_class_moa": [
          "Osmotic Activity [MoA]"
        ],
        "unii": [
          "7SA290YK68",
          "B697894SGQ",
          "FZ989GH94E",
          "0YZT43HS7D"
        ]
      },
      "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-0004-2027",
      "product_description": "Sterile EYE DROPS Advanced Relief, (dextran 70, 0.1%, polyethylene glycol 400 1% and tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15 mL) bottles, Sterile; a) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0456-1; b) Equaline, DISTRIBUTED BY: UNFI, PROVIDENCE, RI 02908 UPC 0 41163 25392 6; c) GoodSense, Distributed By: Geiss, Destin& Dunn, Inc., A Perrigo Company, Peachtree City, GA 30269, www.PerrigoDirect.com, NDC 50804-130-01; d) H.E.B A.C. Eye Drops, MADE WITH PRIDE & CARE FOR H-E-B, SAN ANTONIO, TX 78204, UPC 0 41220 43745 0; e) Medic'c Choice, Manufactured by KC Pharmaceuticals, Inc., Pomona, CA 91768, NDC 55651-025-01; f) Foster & Thrive, Distributed by: McKesson Corp., via Strategic Sourcing Services LLC, Memphis, TN 38141, NDC 70677-1158-1; g) Colirio Manzanill A+, Distributed by: PRO-MEX, P.O Box 63-0716, Miami , FL 33163, UPC: 1 84125 00018 0; h) P, DISTRIBUTED BY PUBLIX SUPER MARKETS, INC, 3300 PUBLIX CORPORATE PARKWAY, LAKELAND, FL 33811, UPC 0 41415 06776 9; I) QC-Quality Choice, Distributed by: CDMA, Inc., Novi, MI 48375, NDC 83324-191-14; J) TopCare health, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELKGROVE VILLAGE, IL 60007, UPC 0 36800 03641 3.",
      "product_quantity": "208,896 cartons",
      "reason_for_recall": "Lack of Assurance of Sterility",
      "recall_initiation_date": "20260911",
      "center_classification_date": "20261005",
      "report_date": "20261014",
      "code_info": "Lot: a) AR25A02, Exp.: 1/1/2027; b) AR25A02, Exp.: 1/1/2027; c) AR25A01, Exp.: 1/1/2027; AR25N01, Exp.: 11/30/2027; d) AR25A02, Exp.: 1/1/2027; e) AR25A02, Exp.: 1/1/2027; f) AR25A02, Exp.: 1/1/2027; g) AR25F01, Exp.: 6/30/2027; AR25N01, Exp.: 11/30/2027; h) AR25A02, Exp.: 1/1/2027; I) AR25A01, Exp.: 1/1/2027; AR25N01, Exp.: 11/30/2027; J) AR25A01, Exp.: 1/1/2027."
    }
  ]
}