{
  "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 Forest",
      "state": "IL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA070583"
        ],
        "brand_name": [
          "BUPIVACAINE HYDROCHLORIDE"
        ],
        "generic_name": [
          "BUPIVACAINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Hospira, Inc."
        ],
        "product_ndc": [
          "0409-1159",
          "0409-1160",
          "0409-1162",
          "0409-1163",
          "0409-1165",
          "0409-9043",
          "0409-9046",
          "0409-9045",
          "0409-9042"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "EPIDURAL",
          "INFILTRATION",
          "INTRACAUDAL",
          "PERINEURAL"
        ],
        "substance_name": [
          "BUPIVACAINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1012377",
          "1012384",
          "1012396",
          "1012404",
          "1672917",
          "1672919",
          "1724786",
          "1724787",
          "1724880",
          "1724884",
          "1725078",
          "1725082",
          "1867594",
          "1867596"
        ],
        "spl_id": [
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        ],
        "spl_set_id": [
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        "package_ndc": [
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          "0409-1159-01",
          "0409-1159-19",
          "0409-1159-02",
          "0409-1160-18",
          "0409-1160-01",
          "0409-1162-18",
          "0409-1162-01",
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          "0409-1162-02",
          "0409-1163-18",
          "0409-1163-01",
          "0409-1165-18",
          "0409-1165-01",
          "0409-1165-19",
          "0409-1165-02",
          "0409-9043-11",
          "0409-9043-01",
          "0409-9046-11",
          "0409-9046-01",
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          "0409-9042-16",
          "0409-9042-17"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "30Q7KI53AK",
          "7TQO7W3VT8"
        ]
      },
      "product_type": "Drugs",
      "event_id": "67045",
      "recalling_firm": "Hospira Inc.",
      "address_1": "375 N Field Dr",
      "address_2": "",
      "postal_code": "60045-2513",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide.",
      "recall_number": "D-395-2014",
      "product_description": "0.5% Bupivacaine HCl and Epinephrine 1:200,000 Inj., 50 mL, Multiple-dose Fliptop Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045. NDC #0409-9046-01.",
      "product_quantity": "65109 vials",
      "reason_for_recall": "Lack of assurance of sterility; equipment failure led to potential breach in asceptic process.",
      "recall_initiation_date": "20131011",
      "center_classification_date": "20140102",
      "termination_date": "20141110",
      "report_date": "20140108",
      "code_info": "Lot #32-484-EV, 32-485-EV  Exp: 2/2015.",
      "more_code_info": ""
    }
  ]
}