{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Princeton",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA089286"
        ],
        "brand_name": [
          "CHLORTHALIDONE"
        ],
        "generic_name": [
          "CHLORTHALIDONE"
        ],
        "manufacturer_name": [
          "Sun Pharmaceutical Industries, Inc."
        ],
        "product_ndc": [
          "57664-648",
          "57664-649"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "CHLORTHALIDONE"
        ],
        "rxcui": [
          "197499",
          "197500"
        ],
        "spl_id": [
          "eca591c9-75f8-2cbb-e053-2a95a90a7cf4"
        ],
        "spl_set_id": [
          "a304de67-cd2b-4933-937e-4eeecf6cda40"
        ],
        "package_ndc": [
          "57664-648-88",
          "57664-648-18",
          "57664-649-88",
          "57664-649-18"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0357664648889",
          "0357664649886"
        ],
        "nui": [
          "N0000175359",
          "N0000175420"
        ],
        "pharm_class_pe": [
          "Increased Diuresis [PE]"
        ],
        "pharm_class_epc": [
          "Thiazide-like Diuretic [EPC]"
        ],
        "unii": [
          "Q0MQD1073Q"
        ]
      },
      "product_type": "Drugs",
      "event_id": "89529",
      "recalling_firm": "SUN PHARMACEUTICAL INDUSTRIES INC",
      "address_1": "2 Independence Way",
      "address_2": "N/A",
      "postal_code": "08540-6620",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide with the United States",
      "recall_number": "D-0578-2022",
      "product_description": "Chlorthalidone Tablets USP 25 mg, Rx Only, 100 Tablets, Sun Pharma, Mfg. by:  Fontida Bio Pharm Inc., 1100 Orthodox St. Philadephia, PA 19124, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-648-88.",
      "product_quantity": "59,232 bottles",
      "reason_for_recall": "Foreign Matter identified as stainless steel microscopic wear particles mixed with punch lubricant oil and silicone particles from the dust cup",
      "recall_initiation_date": "20220207",
      "center_classification_date": "20220223",
      "termination_date": "20230717",
      "report_date": "20220223",
      "code_info": "Lot #: P0602, Exp. Date 03/2023"
    }
  ]
}