{
  "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": [
          "NDA019115"
        ],
        "brand_name": [
          "FENTANYL CITRATE"
        ],
        "generic_name": [
          "FENTANYL CITRATE"
        ],
        "manufacturer_name": [
          "Hospira, Inc."
        ],
        "product_ndc": [
          "0409-9094",
          "0409-9093"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAMUSCULAR",
          "INTRAVENOUS"
        ],
        "substance_name": [
          "FENTANYL CITRATE"
        ],
        "rxcui": [
          "1735003",
          "1735004",
          "1735006",
          "1735007",
          "1735008",
          "1735013"
        ],
        "spl_id": [
          "e4eaad6d-c21e-42fd-8fd9-f0b769966d61"
        ],
        "spl_set_id": [
          "bfa8018a-4cbc-434b-e09e-782872b0340a"
        ],
        "package_ndc": [
          "0409-9093-41",
          "0409-9093-36",
          "0409-9093-31",
          "0409-9093-38",
          "0409-9094-12",
          "0409-9094-22",
          "0409-9094-18",
          "0409-9094-25",
          "0409-9094-17",
          "0409-9094-28",
          "0409-9094-16",
          "0409-9094-31",
          "0409-9094-41",
          "0409-9094-61"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "MUN5LYG46H"
        ]
      },
      "product_type": "Drugs",
      "event_id": "69971",
      "recalling_firm": "Hospira Inc.",
      "address_1": "375 N Field Dr",
      "address_2": "N/A",
      "postal_code": "60045-2513",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-0294-2015",
      "product_description": "Fentanyl Citrate Injection, USP, 2500 mcg Fentanyl/50 mL, 50 mL Single-dose Flip top Vial (C-II), Rx only,  25 units per box/50 units per case, Hospira Inc., Lake Forest, IL --- NDC 0409-9094-61",
      "product_quantity": "62,650 vials",
      "reason_for_recall": "Lack of Assurance of Sterility; improperly crimped fliptop vials",
      "recall_initiation_date": "20141203",
      "center_classification_date": "20141210",
      "termination_date": "20151002",
      "report_date": "20141217",
      "code_info": "Lot 41-099-DK, exp 01MAY2016, NDC 0409-9094-61"
    }
  ]
}