{
  "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": "Cherry Hill",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA076222"
        ],
        "brand_name": [
          "GANCICLOVIR"
        ],
        "generic_name": [
          "GANCICLOVIR SODIUM"
        ],
        "manufacturer_name": [
          "Hikma Pharmaceuticals USA Inc."
        ],
        "product_ndc": [
          "0143-9299"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "GANCICLOVIR SODIUM"
        ],
        "rxcui": [
          "310442"
        ],
        "spl_id": [
          "192fd7cc-3a38-4afe-82f3-a4d89238b1ad"
        ],
        "spl_set_id": [
          "4f8219ca-6780-4131-8962-9c3fdd0a84dd"
        ],
        "package_ndc": [
          "0143-9299-01",
          "0143-9299-10"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "02L083W284"
        ]
      },
      "product_type": "Drugs",
      "event_id": "91333",
      "recalling_firm": "Hikma Pharmaceuticals USA Inc.",
      "address_1": "2 Esterbrook Ln",
      "address_2": "",
      "postal_code": "08003-4002",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "",
      "distribution_pattern": "USA Nationwide",
      "recall_number": "D-0090-2023",
      "product_description": "Ganciclovir for Injection, USP, 500mg per vial, packaged in a 10-count carton, Rx Only, Mfd. by: THYMOORGAN PHARMAZIE GmbH, Germany, Distributed by Hikma Berkeley Heights, NJ 07922, NDC 0143-9299-01",
      "product_quantity": "13,760 vials",
      "reason_for_recall": "Labeling: Label mix-up - one vial was mislabeled as Cladribine Injection 10mg/mL inside a 10-count carton of Ganciclovir 500 mg.",
      "recall_initiation_date": "20221216",
      "center_classification_date": "20221227",
      "termination_date": "20231206",
      "report_date": "20230104",
      "code_info": "Lot#: BQ0006, Exp 08/2023",
      "more_code_info": ""
    }
  ]
}