{
  "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": "2026-09-16",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Cary",
      "state": "NC",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "BLA761092"
        ],
        "brand_name": [
          "REVCOVI"
        ],
        "generic_name": [
          "ELAPEGADEMASE-LVLR"
        ],
        "manufacturer_name": [
          "Chiesi USA, Inc."
        ],
        "product_ndc": [
          "10122-502"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAMUSCULAR"
        ],
        "substance_name": [
          "ELAPEGADEMASE"
        ],
        "rxcui": [
          "2059223",
          "2059228"
        ],
        "spl_id": [
          "1b1625bb-25b0-4845-af56-5c06a0715672"
        ],
        "spl_set_id": [
          "8c073f84-cdd0-40e4-b3a9-172687267f28"
        ],
        "package_ndc": [
          "10122-502-01"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "9R3D3Y0UHS"
        ]
      },
      "product_type": "Drugs",
      "event_id": "99705",
      "recalling_firm": "Chiesi USA, Inc.",
      "address_1": "175 Regency Woods Pl Ste 600",
      "address_2": "N/A",
      "postal_code": "27518-6007",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "MO, TN",
      "recall_number": "D-0838-2026",
      "product_description": "Revcovi (elapegademase-lvlr) Injection, 2.4mg/1.5mL (1.6 mg/mL), Single-Dose Vial, Rx Only, For Intramuscular Use Only, Mfd. by Chiesi USA, Inc., Cary, NC 27518,  NDC 10122-502-01",
      "product_quantity": "3,002 vials",
      "reason_for_recall": "Failed Stability Specifications: Out of specification stability result for the protein concentration profile.",
      "recall_initiation_date": "20260819",
      "center_classification_date": "20260911",
      "report_date": "20260909",
      "code_info": "Lot#: 1221973, Exp 3/24/2027",
      "more_code_info": ""
    }
  ]
}