{
  "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": "Irvine",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "NDA016733"
        ],
        "brand_name": [
          "SODIUM CHLORIDE"
        ],
        "generic_name": [
          "SODIUM CHLORIDE"
        ],
        "manufacturer_name": [
          "B. Braun Medical Inc."
        ],
        "product_ndc": [
          "0264-2201"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "IRRIGATION"
        ],
        "substance_name": [
          "SODIUM CHLORIDE"
        ],
        "rxcui": [
          "486515"
        ],
        "spl_id": [
          "7ba512da-d3fe-40c0-8ff4-99f9771f301e"
        ],
        "spl_set_id": [
          "0d59a04a-32e6-485b-b638-a1e6c09e9642"
        ],
        "package_ndc": [
          "0264-2201-00",
          "0264-2201-10",
          "0264-2201-50",
          "0264-2201-70"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "451W47IQ8X"
        ]
      },
      "product_type": "Drugs",
      "event_id": "96605",
      "recalling_firm": "B. Braun Medical Inc",
      "address_1": "2525 Mcgaw Ave",
      "address_2": "N/A",
      "postal_code": "92614-5841",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Product was distributed to 12 distributors who may have further distributed the product nationwide.",
      "recall_number": "D-0353-2025",
      "product_description": "0.9% Sodium chloride Irrigation USP, Isotonic Solution for Irrigation, 500 mL Plastic Irrigation Container (PIC), B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-2201-10",
      "product_quantity": "32,256 Bottles",
      "reason_for_recall": "Presence of Particulate Matter",
      "recall_initiation_date": "20250331",
      "center_classification_date": "20250408",
      "report_date": "20250416",
      "code_info": "Lot # J4K936, Exp 7/31/2027"
    }
  ]
}