{
  "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": "2026-05-06",
    "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": "98693",
      "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": "US Nationwide.",
      "recall_number": "D-0497-2026",
      "product_description": "0.9 % SODIUM CHLORIDE IRRIGATION, USP, 3000 mL bags, Rx only, Sterile, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7388-60.",
      "product_quantity": "124,244 bags",
      "reason_for_recall": "Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.",
      "recall_initiation_date": "20260402",
      "center_classification_date": "20260428",
      "report_date": "20260429",
      "code_info": "Lot # J5E226, J5E227, J5E228, J5E229, J5E230, J5E231, J5E232, J5E233, J5E238, J5E239, Exp Date: 30Apr2028, Lot # J5E240, J5E241, J5E242, J5E243, J5E244, J5E245, J5E247, J5E248, Exp Date: 30Apr2028, Lot # J5H151, J5H152, J5H153, J5H154, J5H155, Exp Date: 31 May2028.",
      "more_code_info": ""
    }
  ]
}