{
  "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": "Fairfield",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA078203"
        ],
        "brand_name": [
          "LORAZEPAM"
        ],
        "generic_name": [
          "LORAZEPAM"
        ],
        "manufacturer_name": [
          "Leading Pharma, LLC"
        ],
        "product_ndc": [
          "69315-904",
          "69315-905",
          "69315-906"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "LORAZEPAM"
        ],
        "rxcui": [
          "197900",
          "197901",
          "197902"
        ],
        "spl_id": [
          "40249bb6-0d25-4b2f-aa4b-85c15af6bf8b"
        ],
        "spl_set_id": [
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        "package_ndc": [
          "69315-904-01",
          "69315-904-05",
          "69315-904-10",
          "69315-905-01",
          "69315-905-05",
          "69315-905-10",
          "69315-906-01",
          "69315-906-05",
          "69315-906-10"
        ],
        "is_original_packager": [
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        ],
        "upc": [
          "0369315905104",
          "0369315904053",
          "0369315904107",
          "0369315906101",
          "0369315906057",
          "0369315905050",
          "0369315904015",
          "0369315905012",
          "0369315906019"
        ],
        "nui": [
          "N0000175694",
          "M0002356"
        ],
        "pharm_class_epc": [
          "Benzodiazepine [EPC]"
        ],
        "pharm_class_cs": [
          "Benzodiazepines [CS]"
        ],
        "unii": [
          "O26FZP769L"
        ]
      },
      "product_type": "Drugs",
      "event_id": "78471",
      "recalling_firm": "Leading Pharma, LLC",
      "address_1": "3 Oak Rd",
      "address_2": "N/A",
      "postal_code": "07004-2903",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0085-2018",
      "product_description": "Lorazepam Tablets, USP CIV, 0.5 mg, 500-count bottle, Rx Only, Manufactured by: Leading Pharma, LLC Fairfield, NJ 07004 NDC 69315-904-05",
      "product_quantity": "2952 500-count bottles",
      "reason_for_recall": "Labeling: Label Error on Declared Strength. Bottle labeled as 0.5 mg tablets contained 1mg tablets of lorazepam",
      "recall_initiation_date": "20170928",
      "center_classification_date": "20171120",
      "termination_date": "20200921",
      "report_date": "20171129",
      "code_info": "Lot #E00717"
    }
  ]
}