{
  "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 I",
      "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": "69573",
      "recalling_firm": "Hospira Inc.",
      "address_1": "275 N Field Dr",
      "address_2": "",
      "postal_code": "60045-2579",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Telephone",
      "distribution_pattern": "Distribution limited to one shipment to The Harvard Drug Group, Livonia, MI for the lots of Vancomycin 500 mg, Ketorolac tromethamine 60 mg/2 mL (30 mg/mL), and Propofol 1% 200 mg/20 mL (10 mg/mL), these lots remained within the control of the distributor and were not further distributed. Distribution was Nationwide for the Vancomycin 1 g product.",
      "recall_number": "D-0389-2015",
      "product_description": "Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patient infusion vials, packaged in 5 Units per carton, Rx only, Hospira, Inc., Lake Forest, IL  60045, NDC 0409-4699-30.",
      "product_quantity": "2,500 vials",
      "reason_for_recall": "Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.",
      "recall_initiation_date": "20141006",
      "center_classification_date": "20150213",
      "termination_date": "20161215",
      "report_date": "20150225",
      "code_info": "One shipment of Lot #: 33-750-DJ; Exp 1SEP2015 to The Harvard Drug Group, Livonia, MI",
      "more_code_info": ""
    }
  ]
}