{
  "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": "Completed",
      "city": "Daytona Beach",
      "state": "FL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "NDA019635"
        ],
        "brand_name": [
          "SODIUM CHLORIDE"
        ],
        "generic_name": [
          "SODIUM CHLORIDE"
        ],
        "manufacturer_name": [
          "B. Braun Medical Inc."
        ],
        "product_ndc": [
          "0264-5802",
          "0264-5804"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "SODIUM CHLORIDE"
        ],
        "rxcui": [
          "1807552",
          "1807634",
          "1807639"
        ],
        "spl_id": [
          "d34ea9bc-a1f9-402a-97cf-894505cee75d"
        ],
        "spl_set_id": [
          "e44c41ae-c9c8-4dd8-ba6c-cebb585378aa"
        ],
        "package_ndc": [
          "0264-5802-00",
          "0264-5802-10",
          "0264-5804-00",
          "0061794230",
          "0061794232",
          "0061797779",
          "0061797780",
          "0061797781",
          "0061797783",
          "0061797784",
          "0061797785",
          "0061797786",
          "0061797787",
          "0061797788",
          "0061809680"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "451W47IQ8X"
        ]
      },
      "product_type": "Drugs",
      "event_id": "91658",
      "recalling_firm": "B. Braun Medical Inc.",
      "address_1": "1845 Mason Ave",
      "address_2": "N/A",
      "postal_code": "32117-5102",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "USA Nationwide.",
      "recall_number": "D-0347-2023",
      "product_description": "0.9% Sodium Chloride Injection, USP, 500 mL Excel Plus Container, Rx Only, B. Braun Medical Inc. Bethlehem, PA 18018, NDC 0264-5802-10",
      "product_quantity": "483,229 bags",
      "reason_for_recall": "Lack of sterility assurance: Recall of certain batches of 0.9% Sodium Chloride for Injection USP in EXCEL¿ Plus IV Container product due to the possibility of an incomplete seal that may cause leakage.  The impacted lots may exhibit microscopic channel leaks near the port assembly of the product.",
      "recall_initiation_date": "20230210",
      "center_classification_date": "20230223",
      "report_date": "20230301",
      "code_info": "Lots: 0061794230 Exp. 01/31/2024; 0061794232 Exp. 01/31/2024; 0061797779 Exp. 02/29/2024; 0061797780 Exp. 02/29/2024; 0061797781 Exp. 02/29/2024; 0061797783 Exp. 02/29/2024; 0061797784 Exp. 03/31/2024; 0061797785 Exp. 03/31/2024; 0061797786 Exp. 03/31/2024; 0061797787 Exp. 03/31/2024; 0061797788 Exp. 03/31/2024; 0061809680 Exp. 04/30/2024"
    }
  ]
}