{
  "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": "Somerset",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA201693"
        ],
        "brand_name": [
          "NITROFURANTOIN"
        ],
        "generic_name": [
          "NITROFURANTOIN"
        ],
        "manufacturer_name": [
          "Lupin Pharmaceuticals,Inc."
        ],
        "product_ndc": [
          "43386-450"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "NITROFURANTOIN"
        ],
        "rxcui": [
          "311989"
        ],
        "spl_id": [
          "361dd255-19ba-453f-9b68-ade3185ff390"
        ],
        "spl_set_id": [
          "93c37857-38f1-4e2e-acb8-4846840e3e85"
        ],
        "package_ndc": [
          "43386-450-11"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175494",
          "M0014892"
        ],
        "pharm_class_epc": [
          "Nitrofuran Antibacterial [EPC]"
        ],
        "pharm_class_cs": [
          "Nitrofurans [CS]"
        ],
        "unii": [
          "927AH8112L"
        ],
        "upc": [
          "343386450114"
        ]
      },
      "product_type": "Drugs",
      "event_id": "80377",
      "recalling_firm": "LUPIN SOMERSET",
      "address_1": "400 Campus Dr",
      "address_2": "",
      "postal_code": "08873-1145",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide within the US",
      "recall_number": "D-0927-2018",
      "product_description": "Nitrofurantoin Oral Suspension USP, 25mg/5mL, 230 mL Bottle, Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202, UPC 343386-450-114, NDC 43386-450-11",
      "product_quantity": "3456 cartons",
      "reason_for_recall": "Subpotent Drug and Failed Content Uniformity.",
      "recall_initiation_date": "20180628",
      "center_classification_date": "20180718",
      "termination_date": "20230306",
      "report_date": "20180718",
      "code_info": "Lot#: S700065, Exp. 02/2019; 700619, Exp. 08/2019",
      "more_code_info": ""
    }
  ]
}