{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Saint Louis",
      "state": "MO",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "M018"
        ],
        "brand_name": [
          "LUBRICANT EYE DROPS SOLUTION"
        ],
        "generic_name": [
          "POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL"
        ],
        "manufacturer_name": [
          "AvPAK"
        ],
        "product_ndc": [
          "50268-126"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "OPHTHALMIC"
        ],
        "substance_name": [
          "POLYETHYLENE GLYCOL 400",
          "PROPYLENE GLYCOL"
        ],
        "rxcui": [
          "477589"
        ],
        "spl_id": [
          "47e233a3-ffe7-6bf0-e063-6394a90a5b55"
        ],
        "spl_set_id": [
          "f5743b38-e3d2-a065-e053-2995a90a4b9a"
        ],
        "package_ndc": [
          "50268-126-15"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "B697894SGQ",
          "6DC9Q167V3"
        ]
      },
      "product_type": "Drugs",
      "event_id": "96741",
      "recalling_firm": "BRS Analytical Services, LLC",
      "address_1": "11697 Lakeside Crossing Ct",
      "address_2": "N/A",
      "postal_code": "63146-8606",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0407-2025",
      "product_description": "Lubricant Eye Drops Solution, Polyethylene Glycol 400 0.4% Eye Lubricant, Propylene Glycol 0.3% Eye Lubricant, Lubricant Eye Drops, Moisturizing, Sterile, 0.5 FL OZ (15mL) per dropper bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-126-15.",
      "product_quantity": "13,104 cases (24 cartons per case)",
      "reason_for_recall": "cGMP deviations and lack of assurance of sterility.",
      "recall_initiation_date": "20250423",
      "center_classification_date": "20250506",
      "report_date": "20250514",
      "code_info": "Lot, expiry:  Lot 117, exp 9/20/25; Lot 118, exp 9/25/25; Lot 119, exp 9/27/25; Lot 121, exp 10/05/25; Lot 161, exp 5/01/26; Lot 171, exp 6/18/26; Lot 172, exp 6/24/26; Lot 174, exp 7/01/26; Lot 175, exp 7/08/26; Lot 200, exp 11/05/26; Lot 201, exp 11/10/26; Lot 202, exp 11/13/26; Lot 203, exp 11/18/26; Lot 204, exp 11/21/26; Lot 205, exp 11/25/26; Lot 206, exp 12/02/26; Lot 219, exp 2/24/27; Lot 221, exp 3/02/27; Lot 222, exp 3/05/27.",
      "more_code_info": ""
    }
  ]
}