{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Princeton",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA077066"
        ],
        "brand_name": [
          "NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)"
        ],
        "generic_name": [
          "NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)"
        ],
        "manufacturer_name": [
          "Sandoz Inc"
        ],
        "product_ndc": [
          "0185-0122"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "NITROFURANTOIN",
          "NITROFURANTOIN MONOHYDRATE"
        ],
        "rxcui": [
          "1648755"
        ],
        "spl_id": [
          "6fdcd88d-8c7e-40f9-be2e-61be299cc344"
        ],
        "spl_set_id": [
          "7ba9a729-a73a-4a13-a336-0284cc8a67e1"
        ],
        "package_ndc": [
          "0185-0122-01",
          "0185-0122-10"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0301850122011"
        ],
        "nui": [
          "N0000175494",
          "M0014892"
        ],
        "pharm_class_epc": [
          "Nitrofuran Antibacterial [EPC]"
        ],
        "pharm_class_cs": [
          "Nitrofurans [CS]"
        ],
        "unii": [
          "927AH8112L",
          "E1QI2CQQ1I"
        ]
      },
      "product_type": "Drugs",
      "event_id": "81457",
      "recalling_firm": "Sandoz Inc",
      "address_1": "100 College Rd W",
      "address_2": "",
      "postal_code": "08540-6604",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide within the United States",
      "recall_number": "D-0257-2019",
      "product_description": "Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg, packaged in a) 100-capsule bottles (NDC 0185-0122-01); and b) 1000-capsule bottles, (NDC 0185-0122-10); Rx Only, Distributed by Sandoz Inc. Princeton, NJ 08540",
      "product_quantity": "14366 bottles",
      "reason_for_recall": "Cross Contamination with Other Products",
      "recall_initiation_date": "20181102",
      "center_classification_date": "20181120",
      "termination_date": "20201002",
      "report_date": "20181121",
      "code_info": "Lots: a) JB4952, JA7322 Exp. 03/2020; b) JA7324, Exp.03/2020",
      "more_code_info": ""
    }
  ]
}