{
  "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": "64062",
      "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-159-2013",
      "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": "273,925 vials",
      "reason_for_recall": "Presence of Particulate Matter: Visible particulate and particulate embedded in vials were observed during retain inspection.",
      "recall_initiation_date": "20121115",
      "center_classification_date": "20130208",
      "termination_date": "20140227",
      "report_date": "20130220",
      "code_info": "Lot #: a) 95-070-DJ, Exp 11/01/12; 04-584-DJ, 04-652-DJ, Exp 04/01/13; 05-718-DJ, Exp 05/01/13; 06-815-DJ, Exp 06/01/13; b) 04-525-DJ, 04-530-DJ, 04-641-DJ-04-646-DJ, Exp 04/01/13; c) 02-291-DJ, Exp 02/01/13; 05-725-DJ, 05-732-DJ, Exp 05/01/13; 07-925-DJ, Exp 07/01/13; 09-065-DJ, Exp 09/01/13; 10-129-DJ, 10-133-DJ, 10-148-DJ, Exp 10/01/13, Note lot number may be followed by 01.",
      "more_code_info": ""
    }
  ]
}