{
  "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 I",
      "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": "71377",
      "recalling_firm": "Hospira Inc.",
      "address_1": "600 N Field Dr",
      "address_2": "N/A",
      "postal_code": "60045-4835",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "distribution_pattern": "U.S. Nationwide including Guam.",
      "recall_number": "D-1216-2015",
      "product_description": "Bupivacaine Hydrochloride Inj., USP, 0.5% (5 mg/mL), Preservative-Free, 30 mL Single Use Vials, Rx only.  HOSPIRA, INC., LAKE FOREST, IL 60045 USA. NDC: 0409-1162-02.",
      "product_quantity": "150,950 Vials",
      "reason_for_recall": "Presence of Particulate Matter: Presence of free-floating and embedded iron oxide particles.",
      "recall_initiation_date": "20150423",
      "center_classification_date": "20150708",
      "termination_date": "20160126",
      "report_date": "20150715",
      "code_info": "Lot #: 38-515-DK, Expiry: 1 FEB 2016."
    }
  ]
}