{
  "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": "Ongoing",
      "city": "La Vergne",
      "state": "TN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA078203"
        ],
        "brand_name": [
          "LORAZEPAM"
        ],
        "generic_name": [
          "LORAZEPAM"
        ],
        "manufacturer_name": [
          "Major Pharmaceuticals"
        ],
        "product_ndc": [
          "0904-6007",
          "0904-6008",
          "0904-6009"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "LORAZEPAM"
        ],
        "rxcui": [
          "197900",
          "197901",
          "197902"
        ],
        "spl_id": [
          "6b6c2fbc-d12d-41d7-b49d-cf374c773cbd"
        ],
        "spl_set_id": [
          "62f6eb3b-813d-4890-aca9-799b7fa890df"
        ],
        "package_ndc": [
          "0904-6007-60",
          "0904-6007-61",
          "0904-6008-60",
          "0904-6008-61",
          "0904-6009-60",
          "0904-6009-61"
        ],
        "original_packager_product_ndc": [
          "69315-904",
          "69315-905",
          "69315-906"
        ],
        "nui": [
          "N0000175694",
          "M0002356"
        ],
        "pharm_class_epc": [
          "Benzodiazepine [EPC]"
        ],
        "pharm_class_cs": [
          "Benzodiazepines [CS]"
        ],
        "unii": [
          "O26FZP769L"
        ]
      },
      "product_type": "Drugs",
      "event_id": "96151",
      "recalling_firm": "The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories",
      "address_1": "341 Mason Rd",
      "address_2": "N/A",
      "postal_code": "37086-3606",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide U.S. and Puerto rico",
      "recall_number": "D-0227-2025",
      "product_description": "Lorazepam Tablets, USP, 1mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this package is from NDC # 69315-905 Leading Pharma, LLC., Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 26268 USA, NDC: 0904-6008-61.",
      "product_quantity": "94,349 cartons",
      "reason_for_recall": "Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.",
      "recall_initiation_date": "20250121",
      "center_classification_date": "20250219",
      "report_date": "20250226",
      "code_info": "Lot #s: N01419, N01420, N01421, Exp 03/31/2025; N01663, Exp 06/30/2025; N01664, Exp 08/31/2025; N01673, Exp 09/30/2025; N01688, Exp 08/31/2025; N01747, N01748, N01749, Exp 11/30/2025; N01792, Exp 12/31/2025; N01857, Exp 02/28/2026; N01974, Exp 05/31/2026; N02081, Exp 08/31/2026."
    }
  ]
}