{
  "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": "Allentown",
      "state": "PA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "NDA016733"
        ],
        "brand_name": [
          "SODIUM CHLORIDE FOR IRRIGATION"
        ],
        "generic_name": [
          "SODIUM CHLORIDE FOR IRRIGATION"
        ],
        "manufacturer_name": [
          "B. Braun Medical Inc."
        ],
        "product_ndc": [
          "0264-7388"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "IRRIGATION"
        ],
        "substance_name": [
          "SODIUM CHLORIDE"
        ],
        "rxcui": [
          "486515"
        ],
        "spl_id": [
          "69f7d8f6-65cd-45bd-83f7-7249905a2e72"
        ],
        "spl_set_id": [
          "5bd9b176-0402-4a3f-a6b4-c3f393fc092a"
        ],
        "package_ndc": [
          "0264-7388-50",
          "0264-7388-60"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "451W47IQ8X"
        ]
      },
      "product_type": "Drugs",
      "event_id": "97477",
      "recalling_firm": "B BRAUN MEDICAL INC",
      "address_1": "861 Marcon Blvd",
      "address_2": "N/A",
      "postal_code": "18109-9577",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "U.S. Nationwide",
      "recall_number": "D-0653-2025",
      "product_description": "0.9% SODIUM CHLORIDE IRRIGATION USP. ISOTONIC SOLUTION FOR IRRIGATION, 3000mL, Rx only, B. Braun Medical Inc., Bethlehem, PA, 18018, USA, NDC 0264-7388-60.",
      "product_quantity": "16,228 3000 mL bags",
      "reason_for_recall": "Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment.",
      "recall_initiation_date": "20250826",
      "center_classification_date": "20250916",
      "report_date": "20250924",
      "code_info": "Lot#: : J4C521, J4C516, J4C524, Exp. : 28FEB2027."
    }
  ]
}