{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Pine Brook",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "NDA020064"
        ],
        "brand_name": [
          "NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALLINE"
        ],
        "generic_name": [
          "NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE"
        ],
        "manufacturer_name": [
          "Alvogen Inc."
        ],
        "product_ndc": [
          "47781-303"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "NITROFURANTOIN",
          "NITROFURANTOIN MONOHYDRATE"
        ],
        "rxcui": [
          "1648755"
        ],
        "spl_id": [
          "c60467a9-d071-afab-5df9-a6642c176b09"
        ],
        "spl_set_id": [
          "1a86deef-0887-43b1-bb96-dbc222b15931"
        ],
        "package_ndc": [
          "47781-303-01"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0347781303013"
        ],
        "nui": [
          "N0000175494",
          "M0014892"
        ],
        "pharm_class_epc": [
          "Nitrofuran Antibacterial [EPC]"
        ],
        "pharm_class_cs": [
          "Nitrofurans [CS]"
        ],
        "unii": [
          "927AH8112L",
          "E1QI2CQQ1I"
        ]
      },
      "product_type": "Drugs",
      "event_id": "71003",
      "recalling_firm": "Alvogen, Inc",
      "address_1": "10 Bloomfield Ave Bldg B Ste 2",
      "address_2": "N/A",
      "postal_code": "07058-9743",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide and Puerto Rico",
      "recall_number": "D-1082-2015",
      "product_description": "NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS CAPSULES, 100 mg, 100 count bottle, Rx Only --- Distributed by Alvogen, Inc. Pine Brook, NJ 07058; NDC 47781-303-01",
      "product_quantity": "13,392 bottles (100 count)",
      "reason_for_recall": "Failed Dissolution Specification; 6 month time point",
      "recall_initiation_date": "20150421",
      "center_classification_date": "20150514",
      "termination_date": "20151204",
      "report_date": "20150520",
      "code_info": "Lot 457529, exp. 08/2016",
      "more_code_info": ""
    }
  ]
}