{
  "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": "62009",
      "recalling_firm": "Hospira, Inc.",
      "address_1": "600 N Field Dr Bldg J45",
      "address_2": "",
      "postal_code": "60045",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide.",
      "recall_number": "D-1382-2012",
      "product_description": "Propofol Injectable Emulsion, 1%, (10mg/mL), packaged in a) 200 mg/20 mL, 5 Units x 20 mL Single patient infusion vials per carton (NDC 0409-4699-30); b) 1 g/100 mL, 10 Units x 100 mL Single patient infusion vials per carton (NDC 0409-4699-24); Rx only, Hospira, Inc., Lake Forest, IL 60045, USA.",
      "product_quantity": "a) 36,125 vials; b) 31,280 vials",
      "reason_for_recall": "Presence of Particulate Matter: A single visible particulate was observed in a retention sample bottles identified as stainless steel",
      "recall_initiation_date": "20120411",
      "center_classification_date": "20120614",
      "termination_date": "20130627",
      "report_date": "20120620",
      "code_info": "Lot #: a) 03440DJ*, Exp 1MAR2013; b) 07947DJ, Exp 1JUL2013; 10134DJ, Exp 1OCT2013;  Note: * the lot may be followed by 01.",
      "more_code_info": ""
    }
  ]
}