{
  "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": [
          "6e442bfd-d3da-4913-8585-ce3485644364"
        ],
        "spl_set_id": [
          "02a845c3-4521-4926-e397-25ab536e7cf6"
        ],
        "package_ndc": [
          "0409-1159-18",
          "0409-1159-01",
          "0409-1159-19",
          "0409-1159-02",
          "0409-1160-18",
          "0409-1160-01",
          "0409-1162-18",
          "0409-1162-01",
          "0409-1162-19",
          "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",
          "0409-9045-11",
          "0409-9045-01",
          "0409-9045-16",
          "0409-9045-17",
          "0409-9042-11",
          "0409-9042-01",
          "0409-9042-16",
          "0409-9042-17"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "30Q7KI53AK",
          "7TQO7W3VT8"
        ]
      },
      "product_type": "Drugs",
      "event_id": "66295",
      "recalling_firm": "Hospira Inc.",
      "address_1": "275 N Field Dr",
      "address_2": "N/A",
      "postal_code": "60045-2579",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide and Guam and Abu Dhabi",
      "recall_number": "D-66295-001",
      "product_description": "0.5% Bupivacaine HCl and Epinephrine 1:200,000 Inj., 10 mL, Single-Dose Vial, NDC 0409-9045-01, Hospira, Inc., Lake Forest, IL 60045",
      "product_quantity": "187,150 vials",
      "reason_for_recall": "Lack of Assurance of Sterility; potential for vial breakage",
      "recall_initiation_date": "20130905",
      "center_classification_date": "20131007",
      "termination_date": "20141028",
      "report_date": "20131016",
      "code_info": "Lot 17-400-EV* and 17-401-EV * Note: the lot number may be followed by 01"
    }
  ]
}