{
  "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": "Lake Zurich",
      "state": "IL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA091181"
        ],
        "brand_name": [
          "RIFAMPIN"
        ],
        "generic_name": [
          "RIFAMPIN"
        ],
        "manufacturer_name": [
          "Fresenius Kabi USA, LLC"
        ],
        "product_ndc": [
          "63323-351"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "RIFAMPIN"
        ],
        "rxcui": [
          "312821"
        ],
        "spl_id": [
          "60eb9c46-3c34-455b-a740-c03884565072"
        ],
        "spl_set_id": [
          "a1f9f1e2-dfc0-4d31-a13b-b656d897b791"
        ],
        "package_ndc": [
          "63323-351-20"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0363323351205"
        ],
        "nui": [
          "N0000175500",
          "M0019113"
        ],
        "pharm_class_epc": [
          "Rifamycin Antibacterial [EPC]"
        ],
        "pharm_class_cs": [
          "Rifamycins [CS]"
        ],
        "unii": [
          "VJT6J7R4TR"
        ]
      },
      "product_type": "Drugs",
      "event_id": "71409",
      "recalling_firm": "Fresenius Kabi USA, LLC",
      "address_1": "3 Corporate Dr",
      "address_2": "N/A",
      "postal_code": "60047-8930",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide,Hawaii, and Puerto Rico",
      "recall_number": "D-1234-2015",
      "product_description": "Rifampin for Injection, USP 600mg/vial in a 20mL vial, Rx only, Manufactured for Fresenius Kabi LLC 3 Corporate Drive, Lake Zurich, IL, 60047, by Fresenius Kabi LLC, 2020 N Ruby Street, Melrose Park, IL 60160. NDC 63323-351-20",
      "product_quantity": "7,593 vials",
      "reason_for_recall": "Failed Impurities/Degradation Specifications; out-of-specification for color, impurity, and degradation",
      "recall_initiation_date": "20150604",
      "center_classification_date": "20150714",
      "termination_date": "20160519",
      "report_date": "20150722",
      "code_info": "Lot #:  6109469, 6109470, Exp 10/2016",
      "more_code_info": ""
    }
  ]
}