{
  "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": "69247",
      "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",
      "recall_number": "D-1588-2014",
      "product_description": "Bupivacaine HCl Inj., USP, 0.5% (5 mg/mL), 30 mL Single-dose Preservative-Free, For Nerve Block, Caudal, and Epidural Anesthesia, Not for Spinal Anesthesia, Rx Only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-1162-02",
      "product_quantity": "75,000 vials",
      "reason_for_recall": "Presence of Particulate Matter:  A confirmed customer complaint reported the presence of a brown, rust-colored particle embedded at the bottom of the glass vial.",
      "recall_initiation_date": "20140904",
      "center_classification_date": "20140917",
      "termination_date": "20150723",
      "report_date": "20140924",
      "code_info": "LOT 37-268-DK; Exp: 1JAN2016",
      "more_code_info": ""
    }
  ]
}