{
  "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": "63198",
      "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-1685-2012",
      "product_description": "Propofol Injectable Emulsion, 1%, packaged in a) 20 mL Single patient infusion vial, 200 mg/20 mL (10 mg/mL), NDC 0409-4699-30; b) 50 mL Single patient infusion vial, 500 mg/50 mL (10 mg/mL), NDC 0409-4699-33; c) 100 mL Single patient infusion vial, 1 g/100 mL (10 mg/mL), NDC 0409-4699-24; Rx only, Hospira, Inc., Lake Forest, IL 60045 USA",
      "product_quantity": "148,630 vials",
      "reason_for_recall": "Presence of Particulate Matter: A single visible particulate was observed and confirmed in sample bottles of the recalled lots during retain inspection.",
      "recall_initiation_date": "20120829",
      "center_classification_date": "20120921",
      "termination_date": "20130808",
      "report_date": "20121003",
      "code_info": "Lot No: a) 93-857-DJ, 93-896-DJ, Exp 1SEP2012; 04-515-DJ, Exp 1APR2013; 06-802-DJ, Exp 1JUN2013; b) 01-175-DJ, Exp 1JAN2013; 04-565-DJ, Exp 1APR2013; c) 03-388-DJ, Exp 1MAR2013; The lot number may be followed by 01 or 02",
      "more_code_info": ""
    }
  ]
}