{
  "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": "2026-06-24",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Kalyan",
      "state": "",
      "country": "India",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA211320"
        ],
        "brand_name": [
          "CHLORTHALIDONE"
        ],
        "generic_name": [
          "CHLORTHALIDONE"
        ],
        "manufacturer_name": [
          "Rising Pharma Holdings, Inc."
        ],
        "product_ndc": [
          "64980-599",
          "64980-600"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "CHLORTHALIDONE"
        ],
        "rxcui": [
          "197499",
          "197500"
        ],
        "spl_id": [
          "6404aaa7-05c8-4f96-a091-3f07248ffbd5"
        ],
        "spl_set_id": [
          "71b1d074-0521-4cd1-beb5-fedd61f52eca"
        ],
        "package_ndc": [
          "64980-599-01",
          "64980-599-10",
          "64980-600-01"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0364980599108",
          "0364980599016",
          "0364980600019"
        ],
        "nui": [
          "N0000175359",
          "N0000175420"
        ],
        "pharm_class_pe": [
          "Increased Diuresis [PE]"
        ],
        "pharm_class_epc": [
          "Thiazide-like Diuretic [EPC]"
        ],
        "unii": [
          "Q0MQD1073Q"
        ]
      },
      "product_type": "Drugs",
      "event_id": "99136",
      "recalling_firm": "Inventia Healthcare Limited",
      "address_1": "Additional Ambernath Midc",
      "address_2": "Ambernath East; F1-F1/1-F75/1",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "U.S. Nationwide.",
      "recall_number": "D-0610-2026",
      "product_description": "Chlorthalidone Tablets, USP, 25 mg, [100 or 1000] Tablets pr bottle, Rx only, Manufactured by: Inventia Healthcare Limited, Additional Ambernath, M.I.D.C., Ambernath (East) - 421506, INDIA.  Distributed by: Risiong Pharma Holdings, Inc., East Brunswick, NJ 08816.  NDC 100-tablet bottle: 64980-599-01; NDC 1000-tablet bottle: 64980-599-10",
      "product_quantity": "11,460 bottles",
      "reason_for_recall": "Failed Dissolution Specifications",
      "recall_initiation_date": "20260605",
      "center_classification_date": "20260622",
      "report_date": "20260624",
      "code_info": "[100 tablet bottle] Batch RISA24001; [1000 tablet bottle]  Batch RISB24002; Exp. 04/2027",
      "more_code_info": ""
    }
  ]
}