{
  "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": "2026-06-03",
    "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": [
          "QUALITY CHOICE MOISTURIZING RELIEF EYE DROPS",
          "FOSTER AND THRIVE ADVANCED RELIEF EYE DROPS",
          "GOODSENSE EYE DROPS ADVANCED RELIEF MOISTURIZER",
          "CODE RED EYE DROPS REDNESS RELIEF"
        ],
        "generic_name": [
          "DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL",
          "POLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL",
          "DEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL"
        ],
        "manufacturer_name": [
          "Chain Drug Marketing Association, Inc.",
          "Strategic Sourcing Services LLC",
          "Geiss, Derstin & Dunn, Inc.",
          "4 Trees, LLC"
        ],
        "product_ndc": [
          "83324-191",
          "70677-1158",
          "50804-130",
          "83817-963"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "OPHTHALMIC"
        ],
        "substance_name": [
          "DEXTRAN 70",
          "POLYETHYLENE GLYCOL 400",
          "POVIDONE",
          "TETRAHYDROZOLINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "996202",
          "996209"
        ],
        "spl_id": [
          "4749597d-57d8-92b6-e063-6294a90ab574",
          "474922b2-773c-4cff-e063-6394a90a6b3a",
          "47450d1c-db32-92cd-e063-6394a90a0703",
          "2dc61a4e-5308-5145-e063-6294a90a06d7"
        ],
        "spl_set_id": [
          "1fb81759-5931-59c8-e063-6294a90a2277",
          "0019cd99-b245-2ffc-e063-6294a90a9f27",
          "9b34de99-13df-201a-e053-2a95a90ae559",
          "0aa08018-cc2d-d947-e063-6394a90a914a"
        ],
        "package_ndc": [
          "83324-191-14",
          "70677-1158-1",
          "50804-130-01",
          "83817-963-01"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0635515903760",
          "0010939958273",
          "0180410000194",
          "0095072025112",
          "311917200743",
          "050428435441",
          "093351011559",
          "036800036413",
          "095072025563"
        ],
        "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": "98533",
      "recalling_firm": "K.C. Pharmaceuticals, Inc",
      "address_1": "3420 Pomona Blvd",
      "address_2": "",
      "postal_code": "91768-3236",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "Nationwide in the US",
      "recall_number": "D-0410-2026",
      "product_description": "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) Walgreens, DISTRIBUTED BY: WALGREEN CO.,  DEERFIELD, IL 60015; UPC 3 11917 20074 3; b) Kroger, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202; c) CVS Health, Distributed by :CVS Pharmacy, Inc., Woonsocket, RI 02895, UPC 0 50428 43544 1; d) QC-Quality Choice, Distributed by: CDMA, Inc., Novi, MI 48375, NDC 83324-191-14; e) Discount drug mart, Discount Drug Mart Food Fair, Medina, OH 44256, UPC 0 93351 01155 9; f) Foster & Thrive,  Distributed by: McKesson Corp., via SSSL, Memphis, TN 38141, NDC 70677-1158-1; g) GoodSense, Distributed By: Perrigo Direct Inc., Peachtree City, GA 30269, www.PerrigoDirect.com, NDC 50804-130-01; h) TopCare health, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELKGROVE VILLAGE, IL 60007, UPC 0 36800 03641 3; I) DG health Sterile, DISTRIBUTED BY OLD EAST MAIN CO., 100 MISSION RIDGE, GOODLETTSVILLE, TN 37072, UPC 0 95072 02556 3; j) Fast Acting, CODE RED Eye Drops, Sterile, Distributed by: 4 Trees, LLC, NDC 83817-963-01.",
      "product_quantity": "303,216 bottles",
      "reason_for_recall": "Lack of Assurance of Sterility",
      "recall_initiation_date": "20260303",
      "center_classification_date": "20260331",
      "report_date": "20260408",
      "code_info": "Lot: a) AR24D01, Exp.: 04/30/26; AR24G01, AR24G02, Exp.: 07/31/26; AR24M01, Exp.: 10/31/26; b) AR24D01, Exp.: 04/30/26; AR24G01, Exp.: 07/31/26; AR24M01, Exp.: 10/31/26; c) AR24D01, Exp.: 04/30/26; AR24G02, Exp.: 07/31/26; AR24M01, Exp.: 10/31/26; d) AR24G02, Exp.: 07/31/26; e) AR24G02, Exp.: 07/31/26; f)  AR24G02, Exp.: 07/31/26; g) AR24M01, Exp.: 10/31/26, h) AR24G01, Exp.: 07/31/26; AR24M01, Exp.:10/31/26; I) AR24M01, Exp.:10/31/26; j)  AR24D01, Exp.: 04/30/26.",
      "more_code_info": ""
    }
  ]
}