{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Irvine",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "NDA018161"
        ],
        "brand_name": [
          "ACETIC ACID"
        ],
        "generic_name": [
          "ACETIC ACID"
        ],
        "manufacturer_name": [
          "B. Braun Medical Inc."
        ],
        "product_ndc": [
          "0264-2304"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "IRRIGATION"
        ],
        "substance_name": [
          "ACETIC ACID"
        ],
        "rxcui": [
          "307707"
        ],
        "spl_id": [
          "ab98b143-e9d6-4869-9abf-708ec1004f57"
        ],
        "spl_set_id": [
          "dd45cee3-9938-4dad-a5e1-1dd4baea85a9"
        ],
        "package_ndc": [
          "0264-2304-00",
          "0264-2304-10"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "Q40Q9N063P"
        ]
      },
      "product_type": "Drugs",
      "event_id": "78767",
      "recalling_firm": "B. Braun Medical Inc",
      "address_1": "2525 McGaw Ave",
      "address_2": "",
      "postal_code": "92614-5841",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Product was distributed nationwide.",
      "recall_number": "D-0112-2018",
      "product_description": "0.25% Acetic Acid Irrigation USP, 500 mL Plastic Irrigation Container (PIC), B. Braun Medical Inc. Irvine CA 92614-5895 USA, NDC 0264-2304-10",
      "product_quantity": "2,576 containers",
      "reason_for_recall": "Presence of Particulate Matter: identified as polyethylene, which is consistent with the material used to manufacture the contain cap",
      "recall_initiation_date": "20171215",
      "center_classification_date": "20171220",
      "termination_date": "20181018",
      "report_date": "20171227",
      "code_info": "Lot #: J7N965, Exp. 10/31/2020",
      "more_code_info": ""
    }
  ]
}