{
  "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": "Princeton",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA201537"
        ],
        "brand_name": [
          "AZACITIDINE"
        ],
        "generic_name": [
          "AZACITIDINE"
        ],
        "manufacturer_name": [
          "Dr. Reddy's Laboratories Inc."
        ],
        "product_ndc": [
          "43598-305"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS",
          "SUBCUTANEOUS"
        ],
        "substance_name": [
          "AZACITIDINE"
        ],
        "rxcui": [
          "485246"
        ],
        "spl_id": [
          "35e92030-ae2f-04b2-c3de-69f8c8da6b82"
        ],
        "spl_set_id": [
          "71d8d758-86c9-b571-aed1-719654fd4b82"
        ],
        "package_ndc": [
          "43598-305-62"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0343598305622"
        ],
        "nui": [
          "N0000000233",
          "N0000175595"
        ],
        "pharm_class_moa": [
          "Nucleic Acid Synthesis Inhibitors [MoA]"
        ],
        "pharm_class_epc": [
          "Nucleoside Metabolic Inhibitor [EPC]"
        ],
        "unii": [
          "M801H13NRU"
        ]
      },
      "product_type": "Drugs",
      "event_id": "89447",
      "recalling_firm": "Dr. Reddy's Laboratories, Inc.",
      "address_1": "107 College Rd E",
      "address_2": "",
      "postal_code": "08540-6623",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "USA Nationwide",
      "recall_number": "D-0575-2022",
      "product_description": "Azacitidine, 1,00mg/Vial, One Single-dose Vial, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530 046, India, NDC 43598-305-62",
      "product_quantity": "68061 vials",
      "reason_for_recall": "Failed stability specifications",
      "recall_initiation_date": "20220119",
      "center_classification_date": "20220222",
      "termination_date": "20221213",
      "report_date": "20220302",
      "code_info": "Lot #: H200101, H200102, H200099, H200100 & H200106, Exp 8/1/2023; H210015, H210014 & H210013, Exp 11/1/2023; H210086, Exp 12/1/2023; H210130, Exp 1/1/2024; H210171, H210172, H210173, H210174, Exp 2/1/2024; H210196 & H210197, Exp 3/1/2024; H210283 & H210282, Exp 4/1/2024; H210382, H210381, H210419 & H210420, Exp 7/1/2024, H210445, Exp 8/1/2024.",
      "more_code_info": ""
    }
  ]
}