{
  "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": "Terminated",
      "city": "Irvine",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA085870"
        ],
        "brand_name": [
          "POTASSIUM CHLORIDE"
        ],
        "generic_name": [
          "POTASSIUM CHLORIDE"
        ],
        "manufacturer_name": [
          "B. Braun Medical Inc."
        ],
        "product_ndc": [
          "0264-1944"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "PARENTERAL"
        ],
        "substance_name": [
          "POTASSIUM CHLORIDE"
        ],
        "rxcui": [
          "204520"
        ],
        "spl_id": [
          "95c83840-ae78-4210-8b5f-cf4120989811"
        ],
        "spl_set_id": [
          "ab67b151-8368-4321-b562-bad5eff7b740"
        ],
        "package_ndc": [
          "0264-1944-20"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "660YQ98I10"
        ]
      },
      "product_type": "Drugs",
      "event_id": "94184",
      "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": "Nationwide in the USA",
      "recall_number": "D-0370-2024",
      "product_description": "Potassium Chloride for Injection Concentrate USP, 500 mEq/250 mL (2 mEq/mL), 250 mL Bag, Rx only, B. Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-1944-20",
      "product_quantity": "22,752 bags",
      "reason_for_recall": "Lack of assurance of sterility: pinholes, within the blue label characters on the EXCEL bag, specifically within the dotted characters on the label, resulting in leaks.",
      "recall_initiation_date": "20240306",
      "center_classification_date": "20240308",
      "termination_date": "20250416",
      "report_date": "20240320",
      "code_info": "Lot #: J2S007, Exp: 12/31/2024; J3A115, Exp: 01/31/2025."
    }
  ]
}