{
  "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": "2026-07-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "South San Francisco",
      "state": "CA",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "BLA761197"
        ],
        "brand_name": [
          "SUSVIMO"
        ],
        "generic_name": [
          "RANIBIZUMAB"
        ],
        "manufacturer_name": [
          "Genentech, Inc."
        ],
        "product_ndc": [
          "50242-078"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVITREAL"
        ],
        "substance_name": [
          "RANIBIZUMAB"
        ],
        "rxcui": [
          "2584857",
          "2584863"
        ],
        "spl_id": [
          "2850382e-4e4f-4005-a047-33fc758bafef"
        ],
        "spl_set_id": [
          "9c6d9e2a-9a77-4d11-b692-de87cfde3444"
        ],
        "package_ndc": [
          "50242-078-12",
          "50242-078-55",
          "8100425900",
          "0081004259"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000193542",
          "N0000193543"
        ],
        "pharm_class_moa": [
          "Vascular Endothelial Growth Factor Inhibitors [MoA]"
        ],
        "pharm_class_epc": [
          "Vascular Endothelial Growth Factor Inhibitor [EPC]"
        ],
        "unii": [
          "ZL1R02VT79"
        ]
      },
      "product_type": "Drugs",
      "event_id": "90959",
      "recalling_firm": "Genentech Inc",
      "address_1": "1 Dna Way",
      "address_2": "N/A",
      "postal_code": "94080-4918",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0025-2023",
      "product_description": "Susvimo (ranibizumab injection), 100mg/mL, sold together as a) carton containing One Susvimo single-dose vial and One Susvimo initial fill needle, NDC 50242-078-55; and b) carton labeled as Susvimo Ocular Implant with Insertion Tool Assembly, containing One carrier with implant and One insertion Tool, UDI 81004259001, GTIN 00810042590014, Rx only, Genentech, Inc., A Member of the Roche Group, South San Francisco, CA  94080-4990.",
      "product_quantity": "452 vials and implants",
      "reason_for_recall": "Defective Delivery System: Commercial implants do not meet the filed specification for the intended use, a few patients have experienced an issue with the implants that renders it non-functioning.",
      "recall_initiation_date": "20221018",
      "center_classification_date": "20221101",
      "termination_date": "20240417",
      "report_date": "20221109",
      "code_info": "Lot/Exp: a) 3499188, Exp 10/31/2022; Lot 3523071, Exp 6/30/2023; b) 3456735, Exp 10/23/2026; 3456737; Exp 10/29/2026; 3477671, Exp 10/31/2026; 3480781, Exp 12/19/2026; 3506526, Exp 02/25/2027; 3506531, Exp 04/15/2027"
    }
  ]
}