{
  "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": "2026-07-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Baltimore",
      "state": "MD",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA078352"
        ],
        "brand_name": [
          "DESLORATADINE"
        ],
        "generic_name": [
          "DESLORATADINE"
        ],
        "manufacturer_name": [
          "Lupin Pharmaceuticals, Inc."
        ],
        "product_ndc": [
          "68180-153"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "DESLORATADINE"
        ],
        "rxcui": [
          "349420"
        ],
        "spl_id": [
          "4b7fefd7-7d54-400c-a7b4-b3fc4ada2eb1"
        ],
        "spl_set_id": [
          "2a90b899-7746-43dc-ac8a-e754428eb30c"
        ],
        "package_ndc": [
          "68180-153-01",
          "68180-153-03",
          "68180-153-06",
          "68180-153-02",
          "68180-153-11",
          "68180-153-12"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0368180153023"
        ],
        "nui": [
          "N0000000190",
          "N0000175587"
        ],
        "pharm_class_moa": [
          "Histamine H1 Receptor Antagonists [MoA]"
        ],
        "pharm_class_epc": [
          "Histamine-1 Receptor Antagonist [EPC]"
        ],
        "unii": [
          "FVF865388R"
        ]
      },
      "product_type": "Drugs",
      "event_id": "93669",
      "recalling_firm": "Lupin Pharmaceuticals Inc.",
      "address_1": "Harborplace Tower",
      "address_2": "111 S Calvert St Fl 21st",
      "postal_code": "21202-6174",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Product was distributed nationwide.",
      "recall_number": "D-0221-2024",
      "product_description": "Desloratadine Tablets USP 5mg a) 100 count (NDC 68180-153-01) and b) 500 count (NDC 68180-153-02) bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202.",
      "product_quantity": "100=29,184 bottles; 500=2922 bottles",
      "reason_for_recall": "CGMP Deviations: N-Nitroso Desloratadine impurity result exceeded the acceptable intake limit.",
      "recall_initiation_date": "20231220",
      "center_classification_date": "20240109",
      "termination_date": "20250404",
      "report_date": "20240117",
      "code_info": "Lot #  G201822, exp. date Jan 2024, 100 count G201823, exp. date Jan 2024, 100 count G201824, exp. date Jan 2024, 500 count",
      "more_code_info": ""
    }
  ]
}