{
  "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 II",
      "openfda": {
        "application_number": [
          "ANDA201722"
        ],
        "brand_name": [
          "NITROFURANTION"
        ],
        "generic_name": [
          "NITROFURANTION"
        ],
        "manufacturer_name": [
          "Sun Pharmaceutical Industries, Inc."
        ],
        "product_ndc": [
          "57664-231",
          "57664-232",
          "57664-233"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "NITROFURANTOIN"
        ],
        "rxcui": [
          "311994",
          "311995",
          "1648759"
        ],
        "spl_id": [
          "4ed13848-1151-c63a-e063-6394a90a3a05"
        ],
        "spl_set_id": [
          "05f25774-f56a-48ef-bac3-8af663f8581a"
        ],
        "package_ndc": [
          "57664-231-88",
          "57664-231-18",
          "57664-232-88",
          "57664-232-18",
          "57664-233-88",
          "57664-233-18"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0357664232187",
          "0357664233184",
          "0357664231180"
        ],
        "nui": [
          "N0000175494",
          "M0014892"
        ],
        "pharm_class_epc": [
          "Nitrofuran Antibacterial [EPC]"
        ],
        "pharm_class_cs": [
          "Nitrofurans [CS]"
        ],
        "unii": [
          "927AH8112L"
        ]
      },
      "product_type": "Drugs",
      "event_id": "94950",
      "recalling_firm": "SUN PHARMACEUTICAL INDUSTRIES INC",
      "address_1": "2 Independence Way",
      "address_2": "",
      "postal_code": "08540-6620",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA and Puerto rico",
      "recall_number": "D-0597-2024",
      "product_description": "Nitrofurantoin Capsules, USP (Macrocrystals), 100 mg, Rx Only, 100 capsules per bottle, Manufactured by: Sidmak Laboratories (India) Pvt. Ltd. Plot No. 20, Pharmacity, Selaqui Industrial Area, Dehradun - 248-197, Uttarakhand, India. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 57664-233-88.",
      "product_quantity": "5752 bottles",
      "reason_for_recall": "Failed Dissolution Specifications",
      "recall_initiation_date": "20240709",
      "center_classification_date": "20240712",
      "termination_date": "20251222",
      "report_date": "20240724",
      "code_info": "Lot #s: 231067, 231069, Exp 04/30/2025",
      "more_code_info": ""
    }
  ]
}