{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Irvine",
      "state": "CA",
      "country": "United States",
      "classification": "Class I",
      "openfda": {
        "application_number": [
          "NDA050821"
        ],
        "brand_name": [
          "CEFEPIME HYDROCHLORIDE AND DEXTROSE"
        ],
        "generic_name": [
          "CEFEPIME HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "B. Braun Medical Inc."
        ],
        "product_ndc": [
          "0264-3193",
          "0264-3195"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "CEFEPIME HYDROCHLORIDE"
        ],
        "rxcui": [
          "1665088",
          "1665093"
        ],
        "spl_id": [
          "afe666d5-84ec-45a7-ae00-c643b4eaeb35"
        ],
        "spl_set_id": [
          "57517a0e-ec1b-4605-a7cc-7e3801158ec9"
        ],
        "package_ndc": [
          "0264-3193-11",
          "0264-3195-11"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "I8X1O0607P"
        ]
      },
      "product_type": "Drugs",
      "event_id": "66497",
      "recalling_firm": "B. Braun Medical Inc",
      "address_1": "2525 McGaw Ave",
      "address_2": "",
      "postal_code": "92614-5841",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Press Release",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-1054-2014",
      "product_description": "Cefepime for Injection USP and Dextrose Injection USP, in Duplex Drug Delivery System, 1 g in 50 mL duplex container, For IV Use Only, Single Dose, Sterile/Non pyrogenic, Rx Only, B Braun Medical Inc., NDC 0264-3193-11",
      "product_quantity": "18,936 Containers",
      "reason_for_recall": "Presence of Particulate Matter:  The 1g Cefepime for Injection USP and Dextrose Injection USP lot has been found to contain visible organic particulate matter in a reserve sample unit.",
      "recall_initiation_date": "20131015",
      "center_classification_date": "20140131",
      "termination_date": "20141204",
      "report_date": "20140212",
      "code_info": "Lot H3A744, Exp 01/15",
      "more_code_info": ""
    }
  ]
}