{
  "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"
        ]
      },
      "product_type": "Drugs",
      "event_id": "81865",
      "recalling_firm": "LUPIN SOMERSET",
      "address_1": "400 Campus Dr",
      "address_2": "N/A",
      "postal_code": "08873-1145",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA and Puerto Rico.",
      "recall_number": "D-0346-2019",
      "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, NDC 43386-450-11.",
      "product_quantity": "23,460 bottles",
      "reason_for_recall": "Subpotent Drug: Expansion of June 2018 recall of lots S700065 and S700619 due to below specification results for assay.",
      "recall_initiation_date": "20181221",
      "center_classification_date": "20181231",
      "termination_date": "20230315",
      "report_date": "20190109",
      "code_info": "Lot #: S700038, S700044, S700059, S700065, Exp 28-Feb-19; S700410, S700427, Exp 30-Jun-19; S700617, S700619, Exp 31-Aug-19; S700813, S700815, S700869, Exp 31-Oct-19; S700871, S700873, Exp 30-Nov-19; S700875, S701073, Exp 31-Dec-19."
    }
  ]
}