{
  "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": "2026-07-22",
    "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": [
          "EQUATE EYE DROPS DRY EYE RELIEF",
          "SUNMARK EYE DROPS ORIGINAL FORMULA",
          "MEIJER DRY EYE RELIEF",
          "ARTIFICIAL TEARS"
        ],
        "generic_name": [
          "GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400",
          "TETRAHYDROZOLINE HCL",
          "GLYCERIN"
        ],
        "manufacturer_name": [
          "Wal-Mart Stores, Inc.",
          "Strategic Sourcing Services LLC",
          "Meijer Distribution, Inc.",
          "Geri-Care Pharmaceuticals, Corp"
        ],
        "product_ndc": [
          "49035-280",
          "49348-037",
          "41250-718",
          "57896-181"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "OPHTHALMIC"
        ],
        "substance_name": [
          "GLYCERIN",
          "HYPROMELLOSE, UNSPECIFIED",
          "POLYETHYLENE GLYCOL 400",
          "TETRAHYDROZOLINE HYDROCHLORIDE",
          "HYPROMELLOSES"
        ],
        "rxcui": [
          "259581",
          "1052943"
        ],
        "spl_id": [
          "0d291a5f-b639-380c-e063-6394a90a0310",
          "0d295927-09c8-5b68-e063-6394a90a965f",
          "0d22e47a-248f-46d1-e063-6294a90ab3c2",
          "472b069b-4e80-8cb8-e063-6294a90a302b"
        ],
        "spl_set_id": [
          "91fb8fb5-b871-4535-e053-2995a90a9b16",
          "33efa7e9-4c3a-4d72-af31-c5e35095c2ff",
          "9feaa5e2-6aca-96e8-e053-2a95a90a54bd",
          "7cc437e3-bad9-59be-e053-2991aa0a1da3"
        ],
        "package_ndc": [
          "49035-280-01",
          "49035-280-02",
          "49348-037-29",
          "41250-718-01",
          "57896-181-05"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0681131349864",
          "0010939167330",
          "0713733296922",
          "0357896184056",
          "681131367011",
          "095072026560",
          "010939621443",
          "036800361003",
          "052569137154",
          "614299056206",
          "713733296922",
          "041220437412",
          "357896184056"
        ],
        "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",
          "0YZT43HS7D"
        ]
      },
      "product_type": "Drugs",
      "event_id": "92533",
      "recalling_firm": "K.C. Pharmaceuticals, Inc",
      "address_1": "3215 Producer Way",
      "address_2": "N/A",
      "postal_code": "91768-3916",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0898-2023",
      "product_description": "Dry Eye Relief Lubricant Eye Drops, (Glycerin 0.2%, Hypromellose 0.2 %, Polyethylene glycol 400 1%), 0.5 FL OZ (15mL) bottle, packaged in a) equate, DISTRIBUTED BY: Walmart Inc., Bentonville, AR  72716, 2-0.5 FL OZ (15 mL) Bottles, 1 FL OZ (30 mL) TOTAL, UPC 6 81131 36701 1, NDC 49035-280-02; b) DG health, DISTRIBUTED BY OLD EAST MAIN CO., 100 MISSION RIDGE, GOODLETTSVILLE, TN 37072, UPC 0 95072 02656 0; c) sunmark, Distributed By McKesson, 6555 State Highway 161, Irving, TX  75039, UPC 0 10939 62144 3, NDC 49348-037-29; d) TopCare health, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007, UPC 0 36800 36100 3; e) HealthMart, Distributed by McKesson, 6555 State Highway 161, Irving, TX 75039, UPC 0 52569 13715 4; f) exchange select Artificial Tears, Manufactured for your Military Exchanges by: KC Pharmaceuticals, Inc., Pomona, CA 91768, UPC 6 14299 05620 6; g) meijer, DIST. BY MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544, UPC 7 13733 29692 2, NDC 41250-718-01; h) H.E.B, MADE WITH PRIDE AND CARE FOR H.E.B, SAN ANTONIO, TX 78204, UPC 0 41220 43741 2; i) GeriCare, Distributed by: Gericare Pharmaceuticals Corp., 1650 63rd St., Brooklyn, NY 11204, UPC 3 57896 18405 6, NDC 57896-181-05",
      "product_quantity": "397,430 bottles",
      "reason_for_recall": "CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill line.",
      "recall_initiation_date": "20230613",
      "center_classification_date": "20230707",
      "report_date": "20230719",
      "code_info": "Lot #: a) LT21FO2, LT21F03, Exp 6/2023; b) LT21FO2, LT21F03, Exp 6/2023; c) LT21FO2, LT21F03, Exp 6/2023; d) LT21FO2, LT21F03, Exp 6/2023; e) LT21F02, Exp 6/2023; f) LT21F02, Exp 6/2023; g) LT21F03, Exp 6/2023; h) LT21F03, Exp 6/2023; i) LT21F03, Exp 6/2023",
      "more_code_info": ""
    }
  ]
}