{
  "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": "67601",
      "recalling_firm": "Hospira Inc.",
      "address_1": "275 N Field Dr",
      "address_2": "",
      "postal_code": "60045-2579",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-1147-2014",
      "product_description": "Bupivacaine HCl Inj. USP, 0.5% (5 mg/mL), 30 mL Single-dose Preservative Free Vial, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1162-02",
      "product_quantity": "115,500 Vials",
      "reason_for_recall": "Presence of Particulate Matter: Confirmed customer report of visible particulate embedded in the glass vial.",
      "recall_initiation_date": "20140210",
      "center_classification_date": "20140305",
      "termination_date": "20170201",
      "report_date": "20140312",
      "code_info": "Lot 25-097-DK; Exp 01/01/2015",
      "more_code_info": ""
    }
  ]
}