{
  "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 DRY EYE RELIEF EYE DROPS",
          "ARTIFICIAL TEARS",
          "FOSTER AND THRIVE DRY EYE RELIEF"
        ],
        "generic_name": [
          "GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400",
          "GLYCERIN",
          "POLYETHYLENE GLYCOL 400"
        ],
        "manufacturer_name": [
          "CARDINAL HEALTH 110, LLC. DBA LEADER",
          "Geri-Care Pharmaceuticals, Corp",
          "Strategic Sourcing Services LLC"
        ],
        "product_ndc": [
          "70000-0502",
          "57896-181",
          "70677-1157"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "OPHTHALMIC"
        ],
        "substance_name": [
          "GLYCERIN",
          "HYPROMELLOSE, UNSPECIFIED",
          "POLYETHYLENE GLYCOL 400",
          "HYPROMELLOSES"
        ],
        "rxcui": [
          "259581",
          "2360899"
        ],
        "spl_id": [
          "5944f7bf-c84b-497f-e063-6394a90aed1f",
          "472b069b-4e80-8cb8-e063-6294a90a302b",
          "4749275b-6982-4eaf-e063-6394a90aaee9"
        ],
        "spl_set_id": [
          "2ded4bda-b3c3-4521-8701-5c8446fd148b",
          "7cc437e3-bad9-59be-e053-2991aa0a1da3",
          "0018ade9-5856-db6c-e063-6394a90a2ccf"
        ],
        "package_ndc": [
          "70000-0502-1",
          "70000-0502-2",
          "57896-181-05",
          "70677-1157-1"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0096295137064",
          "0096295137071",
          "0357896184056",
          "0010939958266",
          "867166000004",
          "093351011566",
          "614299056206",
          "041220437412",
          "072036713032",
          "036800361003"
        ],
        "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",
          "3NXW29V3WO",
          "B697894SGQ"
        ]
      },
      "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-0006-2027",
      "product_description": "Sterile Lubricant Dry Eye Relief Eye Drops, 0.5 FL OZ (15 mL); a) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0502-1; b) Crocodile Tears, Distributed by: Crocodile Tears, Palm Beach Gardens, FL 33410, UPC: 8 67166 00000 4; c) Discount drug mart, Discount Drug Mart Food Fair, Medina, OH 44256, UPC: 0 93351 01156 6; d) exchange select, Manufactured for your Military Exchange By: K.C Pharmaceuticals, Inc., Pomona, CA 9176, UPC: 6 14299 05620 6; e) GERI CARE, Distributed by: Gericare Pharmaceuticals Corp., 1295 Towbin Ave., Lakewood, NJ 08701, NDC 57896-181-05; f) H.E.B Dry Eye,  Eye Drops, MADE WITH PRIDE & CARE FOR H-E-B, SAN ANTONIO, TX 78204, UPC 0 41220 43741 2; g) Harris Teeter, PROUDLY DISTRIBUTED BY: HARRIS TEETER, LLC, MATTHEWS, NC 28105, UPC: 0 72036 71303 2; h) Foster & Thrive, Distributed by: McKesson Corp. Via Strategic Sourcing Servies LLC., Memphis, TN 38141, NDC 70677-1157-1; I) TopCare health, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELKGROVE VILLAGE, IL 60007, UPC 0 36800 36100 3.",
      "product_quantity": "1,327,248 cartons",
      "reason_for_recall": "Lack of Assurance of Sterility",
      "recall_initiation_date": "20260911",
      "center_classification_date": "20261005",
      "report_date": "20261014",
      "code_info": "Lot: a) LT25B01, Exp.: 02/28/2027; b) LT25D02, Exp.: 04/30/2027; LT25K01, Exp.: 09/30/2027; c) LT25D02, Exp.: 04/30/2027; LT25K01, Exp.: 09/30/2027; d) LT25D02, Exp.: 04/30/2027; LT25M02, Exp.: 10/31/2027; e) LT25B01, Exp.: 02/28/2027; LT25D01, Exp.: 04/30/2027; LT25D02, Exp.: 04/30/2027; LT25K01, Exp.: 09/30/2027; LT25M01, Exp.: 10/31/2027; LT25M02, Exp.: 10/31/2027; LT25N01, Exp.: 11/30/2027; LT25N02, Exp.: 11/30/2027; f) LT25B01, Exp.: 02/28/2027; g) LT25M02, Exp.: 10/31/2027; h) LT25B01, Exp.: 02/28/2027; I) LT25B01, Exp.: 02/28/2027; LT25D02, Exp.: 04/30/2027; LT25M02, Exp.: 10/31/2027."
    }
  ]
}