{
  "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": "2026-10-14",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Malvern",
      "state": "PA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "BLA761430"
        ],
        "brand_name": [
          "IMAAVY"
        ],
        "generic_name": [
          "NIPOCALIMAB-AAHU"
        ],
        "manufacturer_name": [
          "Janssen Biotech, Inc."
        ],
        "product_ndc": [
          "57894-800",
          "57894-801"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "NIPOCALIMAB"
        ],
        "rxcui": [
          "2712699",
          "2712706",
          "2712708",
          "2712709"
        ],
        "spl_id": [
          "38376edc-230b-4b2b-8bb6-55b9dccea7a5"
        ],
        "spl_set_id": [
          "8886274c-f2b2-48af-85c1-2f90bfe304b8"
        ],
        "package_ndc": [
          "57894-801-01",
          "57894-800-01"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "87M90CV8NC"
        ]
      },
      "product_type": "Drugs",
      "event_id": "99972",
      "recalling_firm": "J&J INNOVATIVE MEDICINE",
      "address_1": "200 Great Valley Pkwy",
      "address_2": "N/A",
      "postal_code": "19355-1307",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "OH",
      "recall_number": "D-0016-2027",
      "product_description": "IMAAVY (nipocalimab-aahu) Injection, 300 mg /1.62 mL (185 mg/mL) per single-dose vial, For Intravenous Infusion After Dilution, Rx only, Manufactured by: Janssen Biotech, Inc., Horsham, PA 19044.  NDC: 57894-800-01",
      "product_quantity": "49 vials",
      "reason_for_recall": "Presence of particulate matter.",
      "recall_initiation_date": "20260923",
      "center_classification_date": "20261008",
      "report_date": "20261014",
      "code_info": "Lot JNYJ1208; Exp. 10/30/2027"
    }
  ]
}