{
  "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": "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": "83434",
      "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": "Natonwide, PR",
      "recall_number": "D-1722-2019",
      "product_description": "Nitrofurantoin Monohydrate/Macrycrystals Capsules, 100 mg, 100-count bottle, Rx Only, Distributed by: Alvogen, Inc. Pine Brook, NY 07058 USA, NDC 47781-303-01",
      "product_quantity": "2784 bottles",
      "reason_for_recall": "Failed dissolution specifications",
      "recall_initiation_date": "20190724",
      "center_classification_date": "20190812",
      "termination_date": "20210804",
      "report_date": "20190821",
      "code_info": "Lot # 471976, Exp 03/2020"
    }
  ]
}