{
  "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": [
          "ANDA077908"
        ],
        "brand_name": [
          "PROPOFOL"
        ],
        "generic_name": [
          "PROPOFOL"
        ],
        "manufacturer_name": [
          "Hospira, Inc."
        ],
        "product_ndc": [
          "0409-4699",
          "0409-6010"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "PROPOFOL"
        ],
        "rxcui": [
          "1808217",
          "1808222",
          "1808224"
        ],
        "spl_id": [
          "6b15a686-96ff-4f19-8638-bce64d91e266"
        ],
        "spl_set_id": [
          "28d7ba00-f824-4e55-139a-03f509c099db"
        ],
        "package_ndc": [
          "0409-4699-50",
          "0409-4699-30",
          "0409-4699-53",
          "0409-4699-33",
          "0409-4699-54",
          "0409-4699-24",
          "0409-6010-02",
          "0409-6010-25"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175975",
          "N0000175681"
        ],
        "pharm_class_pe": [
          "General Anesthesia [PE]"
        ],
        "pharm_class_epc": [
          "General Anesthetic [EPC]"
        ],
        "unii": [
          "YI7VU623SF"
        ]
      },
      "product_type": "Drugs",
      "event_id": "64719",
      "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-223-2013",
      "product_description": "Propofol Injectable Emulsion, 1%, packaged in a) 5 x 20 mL Single patient infusion vials per carton, 200 mg/20 mL (10 mg/mL), NDC 0409-4699-30; b) 10 x 100 mL Single patient infusion vials per carton, 1 g/100 mL (10 mg/mL), NDC 0409-4699-24; Rx only, Hospira, Inc., Lake Forest, IL 60045 USA.",
      "product_quantity": "68,020 vials",
      "reason_for_recall": "Presence of Particulate Matter: Visible particulate embedded in vials was observed and confirmed in a sample bottle during retain inspection.",
      "recall_initiation_date": "20130225",
      "center_classification_date": "20130328",
      "termination_date": "20141008",
      "report_date": "20130403",
      "code_info": "a) Lot #: 06-804-DJ*, Exp 1JUN2013; and b) Lot #: 05-736-DJ*, Exp 1MAY2013; 09-066-DJ*, Exp 1SEP2013. *Note: the lot number may be followed by 01 or 02.",
      "more_code_info": ""
    }
  ]
}