{
  "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": "Ongoing",
      "city": "Parsippany",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "BLA125294"
        ],
        "brand_name": [
          "GRANIX"
        ],
        "generic_name": [
          "TBO-FILGRASTIM"
        ],
        "manufacturer_name": [
          "Cephalon, LLC"
        ],
        "product_ndc": [
          "63459-910",
          "63459-912",
          "63459-918",
          "63459-920"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "SUBCUTANEOUS"
        ],
        "substance_name": [
          "FILGRASTIM"
        ],
        "rxcui": [
          "1433768",
          "1433771",
          "1442681",
          "1442683",
          "2101456",
          "2101459",
          "2101464",
          "2101465"
        ],
        "spl_id": [
          "063f36a7-6f99-40fa-af02-8a5183c51e99"
        ],
        "spl_set_id": [
          "df918ec2-0907-443f-a52a-b72866959644"
        ],
        "package_ndc": [
          "63459-910-01",
          "63459-910-12",
          "63459-910-11",
          "63459-910-15",
          "63459-910-18",
          "63459-910-17",
          "63459-910-36",
          "63459-912-01",
          "63459-912-12",
          "63459-912-11",
          "63459-912-15",
          "63459-912-18",
          "63459-912-17",
          "63459-912-36",
          "63459-918-53",
          "63459-918-59",
          "63459-920-53",
          "63459-920-59"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "M0024696",
          "N0000009451",
          "N0000175666"
        ],
        "pharm_class_cs": [
          "Granulocyte Colony-Stimulating Factor [CS]"
        ],
        "pharm_class_pe": [
          "Increased Myeloid Cell Production [PE]"
        ],
        "pharm_class_epc": [
          "Leukocyte Growth Factor [EPC]"
        ],
        "unii": [
          "PVI5M0M1GW"
        ]
      },
      "product_type": "Drugs",
      "event_id": "96115",
      "recalling_firm": "Teva Pharmaceuticals USA, Inc",
      "address_1": "400 Interpace Pkwy Bldg A",
      "address_2": "",
      "postal_code": "07054-1120",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Product was distributed nationwide.",
      "recall_number": "D-0218-2025",
      "product_description": "Granix (tbo-filgrastim) Injection 300 mcg/0.5 mL, Single Dose prefilled syringe, packaged as a) 1 syringe in 1 CARTON, NDC 63459-910-11, Blister NDC 63459-910-12; (b)10 syringes in 1 CARTON, NDC 63459-910-15, Blister NDC 63459-910-12; (c) 1 syringe in 1 CARTON, NDC 63459-910-17 without safety guard and blister, Rx Only, Manufactured by: UAB Teva Baltics, Vilnius, Lithuania. Distributed by Teva Pharmaceuticals USA, Inc. North Wales PA 19454. Product of Israel.",
      "product_quantity": "34,636 cartons",
      "reason_for_recall": "Failed Stability Specifications - 12-month stability test result for one of the known peptides is below the specification limit",
      "recall_initiation_date": "20250110",
      "center_classification_date": "20250204",
      "report_date": "20250212",
      "code_info": "Lot #  (a) 135738, (b) 137149, (c) 137148, Exp. date 09/30/2025",
      "more_code_info": ""
    }
  ]
}