{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Raleigh",
      "state": "NC",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "BLA761364"
        ],
        "brand_name": [
          "IMULDOSA"
        ],
        "generic_name": [
          "USTEKINUMAB-SRLF"
        ],
        "manufacturer_name": [
          "Accord BioPharma Inc."
        ],
        "product_ndc": [
          "69448-017",
          "69448-018",
          "69448-019"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "SUBCUTANEOUS"
        ],
        "substance_name": [
          "USTEKINUMAB-SRLF"
        ],
        "rxcui": [
          "2717067",
          "2717074",
          "2717078",
          "2717083",
          "2717085",
          "2717086"
        ],
        "spl_id": [
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        ],
        "spl_set_id": [
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        ],
        "package_ndc": [
          "69448-018-63",
          "69448-017-63",
          "69448-019-26"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0369448017637",
          "0369448018634"
        ],
        "unii": [
          "FU77B4U5Z0"
        ]
      },
      "product_type": "Drugs",
      "event_id": "99216",
      "recalling_firm": "ACCORD BIOPHARMA INC",
      "address_1": "8041 Arco Corporate Dr Ste 200",
      "address_2": "N/A",
      "postal_code": "27617-2091",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide.",
      "recall_number": "D-0653-2026",
      "product_description": "IMULDOSA, (ustekinumab-srlf) Injection, 130 mg/26 mL (5mg/mL), Rx only, Single dose vial, Manufactured by Accord BioPharma Inc., 8041 Arco corporate Drive, Suite 200, Raleigh, NC 27617, USA, Manufactured at: Catalent Indiana, LLC, 1300 S. Patterson Drive, Bloomington, IN 47403, USA, NDC 69448-019-26.",
      "product_quantity": "326 vials",
      "reason_for_recall": "Lack of assurance of Sterility:",
      "recall_initiation_date": "20260610",
      "center_classification_date": "20260629",
      "report_date": "20260708",
      "code_info": "Lot # 004L24A, Exp Date: 02/19/2027."
    }
  ]
}