{
  "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": "Saint Louis",
      "state": "MO",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "M018"
        ],
        "brand_name": [
          "ARTIFICIAL TEARS"
        ],
        "generic_name": [
          "ARTIFICIAL TEARS"
        ],
        "manufacturer_name": [
          "AvPAK"
        ],
        "product_ndc": [
          "50268-043"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "OPHTHALMIC"
        ],
        "substance_name": [
          "DEXTRAN 70",
          "GLYCERIN",
          "HYPROMELLOSES"
        ],
        "rxcui": [
          "900138"
        ],
        "spl_id": [
          "5606f407-17ba-2cdc-e063-6394a90a7dd2"
        ],
        "spl_set_id": [
          "f18bebf2-1936-658f-e053-2a95a90a5012"
        ],
        "package_ndc": [
          "50268-043-15"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000184175",
          "N0000009361",
          "N0000010288",
          "N0000185370",
          "N0000175629",
          "N0000184306",
          "N0000185001",
          "M0000728",
          "M0009417"
        ],
        "pharm_class_epc": [
          "Plasma Volume Expander [EPC]",
          "Non-Standardized Chemical Allergen [EPC]"
        ],
        "pharm_class_pe": [
          "Increased Intravascular Volume [PE]",
          "Increased Histamine Release [PE]",
          "Cell-mediated Immunity [PE]",
          "Increased IgG Production [PE]"
        ],
        "pharm_class_moa": [
          "Osmotic Activity [MoA]"
        ],
        "pharm_class_cs": [
          "Allergens [CS]",
          "Glycerol [CS]"
        ],
        "unii": [
          "7SA290YK68",
          "PDC6A3C0OX",
          "3NXW29V3WO"
        ]
      },
      "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-0404-2025",
      "product_description": "Artificial Tears Ophthalmic Solution, Dextran 70.01%/Glycerin 0.2%/Hypromellose 0.3% (Eye Lubricants) Lubricant Eye Drops, STERILE, 0.5 FL OZ (15 mL) per dropper bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-043-15.",
      "product_quantity": "13,872 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 126, exp 10/26/25; Lot 127, exp 10/30/25; Lot 128, exp 11/02/25; Lot 129, exp 11/06/25; Lot 162, exp 5/09/26; Lot 163, exp 5/14/26; Lot 164, exp 5/20/26; Lot 165, exp 5/23/26; Lot 166, exp 5/29/26; Lot 167, exp 6/03/26; Lot 168, exp 6/06/26; Lot 169, exp 6/10/26; Lot 170, exp 6/13/26; Lot 193, exp 10/07/26; Lot 194, exp 10/10/26; Lot 195, exp 10/14/26; Lot 196, exp 10/17/26; Lot 197, exp 10/21/26; Lot 198, exp 10/24/26; Lot 199, exp 10/30/26.",
      "more_code_info": ""
    }
  ]
}