{
  "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 EYE DROPS REDNESS RELIEF",
          "EQUATE REDNESS AND DRY EYE RELIEF EYE DROPS"
        ],
        "generic_name": [
          "GLYCERIN, NAPHAZOLINE HYDROCHLORIDE",
          "GLYCERIN, NAPHAZOLINE HCL"
        ],
        "manufacturer_name": [
          "Cardinal Health",
          "Wal-Mart Stores, Inc."
        ],
        "product_ndc": [
          "70000-0010",
          "79903-012"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "OPHTHALMIC"
        ],
        "substance_name": [
          "GLYCERIN",
          "NAPHAZOLINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1046700"
        ],
        "spl_id": [
          "5b11dcac-4699-9567-e063-6294a90aadf3",
          "474945a2-ec0b-0a68-e063-6294a90a1088"
        ],
        "spl_set_id": [
          "aee4bbe2-4f11-4c54-be8b-df48b3ba4f3a",
          "ae228018-9238-2cbd-e053-2995a90a8d99"
        ],
        "package_ndc": [
          "70000-0010-1",
          "70000-0010-2",
          "79903-012-01"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0096295137620",
          "0096295137637",
          "0681131395342",
          "093351034114",
          "041163461512",
          "348201016155",
          "678112254156",
          "311917177410"
        ],
        "nui": [
          "N0000185370",
          "N0000175629",
          "N0000184306",
          "N0000185001",
          "M0000728",
          "M0009417"
        ],
        "pharm_class_epc": [
          "Non-Standardized Chemical Allergen [EPC]"
        ],
        "pharm_class_pe": [
          "Increased Histamine Release [PE]",
          "Cell-mediated Immunity [PE]",
          "Increased IgG Production [PE]"
        ],
        "pharm_class_cs": [
          "Allergens [CS]",
          "Glycerol [CS]"
        ],
        "unii": [
          "PDC6A3C0OX",
          "MZ1131787D"
        ]
      },
      "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-0008-2027",
      "product_description": "Sterile Eye Drops  Redness Relief (Glycerin 0.25%, Naphazoline HCl 0.02%   Lubricant | Redness Reliever) (Relieves Dryness, Burning and Irritations), 0.5 fl oz (15 mL); a) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0010-1; b) Discount drug mart, Distributed by: Discount Drug Mart, 211 Commerce Drive, Medina, OH 44256, UPC: 0 93351 03411 4; c) EQUALINE, DISTRIBUTED BY: UNFI, PROVIDENCE, RI 02908 UPC 0 41163 46151 2; d) Colirio Ojo de Aguila, Distributed by Grandall Distributing Co., Inc., Glendale, CA 91204, UPC: 3 48201 01615 5; e) Clear Eyes   Redness Relief, ¿ 2025 Dist. by Medtech Products Inc., Tarrytown, NY 10591, UPC 6 78112 25415 6; f) Equate\", DISTRIBUTED BY WALMART INC., Bentonville, AR 72716, NDC 79903-012-01; g)  Walgreens, DISTRIBUTED BY: WALGREEN CO., 200 WILMOT RD, DEERFIELD, IL 60015, UPC 3 11917 17741 0; h) Xpect   Industrial Eye Relief, Distributed by: Cintas Corp., Mason, OH 45040, UPC: 130209.",
      "product_quantity": "N/A",
      "reason_for_recall": "Lack of Assurance of Sterility",
      "recall_initiation_date": "20260911",
      "center_classification_date": "20261005",
      "report_date": "20261014",
      "code_info": "Lot: a) RL25D01, Exp.: 04/30/2027; RL25G01, Exp.: 07/31/2027; RL25K05, Exp.: 09/30/2027; RL25N03, Exp.: 11/30/2027; b) RL25D01, Exp.: 04/30/2027; RL25G01, Exp.: 07/31/2027; c) RL25D01, Exp.: 04/30/2027; d) RL25E01, Exp.: 05/31/2027; RL25K05, Exp.: 09/30/2027; e) RL25G02, Exp.: 07/31/2027; RL25G03, Exp.: 07/31/2027; RL25G04, Exp.: 07/31/2027; RL25H02, Exp.: 08/30/2028; RL25H03, Exp.: 08/30/2028; RL25H04, Exp.: 08/30/2028; RL25K01, Exp.: 09/30/2027; RL25K02, Exp.: 09/30/2027; RL25K03, Exp.: 09/30/2027; RL25K04, Exp.: 09/30/2027; RL25M01, Exp.: 10/31/2027; RL25M02, Exp.: 10/31/2027; RL25M03, Exp.: 10/31/2027; RL25M04, Exp.: 10/31/2027; RL25N01, Exp.: 11/30/2027; RL25N02, Exp.: 11/30/2027; RL25N04, Exp.: 11/30/2027;  f) RL25E01, Exp.: 05/31/2027; RL25G01, Exp.: 07/31/2027; RL25H01, Exp.: 08/30/2028; RL25K05, Exp.: 09/30/2027; RL25M05, Exp.: 10/31/2027; RL25N03, Exp.: 11/30/2027; g) RL25D01, Exp.: 04/30/2027; RL25E01, Exp.: 05/31/2027; RL25G01, Exp.: 07/31/2027; RL25H01, Exp.: 08/30/2028; RL25K05, Exp.: 09/30/2027; RL25N03, Exp.: 11/30/2027; h) RL25D01, Exp.: 04/30/2027; RL25E01, Exp.: 05/31/2027; RL25H01, Exp.: 08/30/2028; RL25K05, Exp.: 09/30/2027; RL25M05, Exp.: 10/31/2027; RL25N03, Exp.: 11/30/2027."
    }
  ]
}