{
  "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": [
          "NDA018681"
        ],
        "brand_name": [
          "LACTATED RINGERS IRRIGATION"
        ],
        "generic_name": [
          "SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE AND CALCIUM CHLORIDE"
        ],
        "manufacturer_name": [
          "B. Braun Medical Inc."
        ],
        "product_ndc": [
          "0264-7389"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "IRRIGATION"
        ],
        "substance_name": [
          "CALCIUM CHLORIDE",
          "POTASSIUM CHLORIDE",
          "SODIUM CHLORIDE",
          "SODIUM LACTATE"
        ],
        "rxcui": [
          "847628"
        ],
        "spl_id": [
          "4bf1e3a5-1742-4843-ad41-f4e7c9c2936e"
        ],
        "spl_set_id": [
          "0db56c7a-2b8f-4593-8591-2c481c92b2cf"
        ],
        "package_ndc": [
          "0264-7389-60"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "M4I0D6VV5M",
          "660YQ98I10",
          "451W47IQ8X",
          "TU7HW0W0QT"
        ]
      },
      "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-0498-2026",
      "product_description": "LACTATED RINGER'S IRRIGATION, 3000 mL bags, Sterile, Ex only, B. Braun Medical Inc., Bethlehem, PA 18018-3524, USA, NDC: 0264-7389-60.",
      "product_quantity": "54,540 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 # J5E234, J5E236, Exp Date: 30APR2028; Lot # J5H158, J5H159, J5H160, J5H161,  J5H162, J5H163, J5H174, J5H175, Exp Date: 31MAY2028.",
      "more_code_info": ""
    }
  ]
}