{
  "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": "2026-06-03",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Cary",
      "state": "NC",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "BLA020744"
        ],
        "brand_name": [
          "CUROSURF"
        ],
        "generic_name": [
          "PORACTANT ALFA"
        ],
        "manufacturer_name": [
          "Chiesi USA, Inc."
        ],
        "product_ndc": [
          "10122-510"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ENDOTRACHEAL"
        ],
        "substance_name": [
          "PORACTANT ALFA"
        ],
        "rxcui": [
          "259216",
          "261329"
        ],
        "spl_id": [
          "6b713a41-2648-43f4-9a10-cc41a7e83ca0"
        ],
        "spl_set_id": [
          "99bef307-00bd-4379-9f45-ede1380e74d4"
        ],
        "package_ndc": [
          "10122-510-03",
          "10122-510-01"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000008294",
          "N0000175778",
          "N0000000079"
        ],
        "pharm_class_pe": [
          "Alveolar Surface Tension Reduction [PE]"
        ],
        "pharm_class_epc": [
          "Surfactant [EPC]"
        ],
        "pharm_class_moa": [
          "Surfactant Activity [MoA]"
        ],
        "unii": [
          "KE3U2023NP"
        ]
      },
      "product_type": "Drugs",
      "event_id": "98593",
      "recalling_firm": "Chiesi USA, Inc.",
      "address_1": "175 Regency Woods Pl Ste 600",
      "address_2": "",
      "postal_code": "27518-6007",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide within the United States",
      "recall_number": "D-0402-2026",
      "product_description": "CUROSURF (poractant alfa), 240 mg, Intratracheal Suspension, 3L Single-dose-Vial, Rx only, Chiesi USA, Inc, Cary, NC 27518, NDC 10122-510-03.",
      "product_quantity": "7,235 vials",
      "reason_for_recall": "Lack of Assurance of Sterility",
      "recall_initiation_date": "20260317",
      "center_classification_date": "20260320",
      "report_date": "20260401",
      "code_info": "Lot #: 1213748, Exp. Date 09/2026; 1215076, 1215077, Exp. Date 10/26.",
      "more_code_info": ""
    }
  ]
}