{
  "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": "Brookhaven",
      "state": "NY",
      "country": "United States",
      "classification": "Class I",
      "openfda": {
        "application_number": [
          "ANDA091383"
        ],
        "brand_name": [
          "LORAZEPAM"
        ],
        "generic_name": [
          "LORAZEPAM"
        ],
        "manufacturer_name": [
          "Amneal Pharmaceuticals LLC"
        ],
        "product_ndc": [
          "65162-687"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "LORAZEPAM"
        ],
        "rxcui": [
          "311376"
        ],
        "spl_id": [
          "99b5d0cb-3d61-497c-9b51-7d0939f923a0"
        ],
        "spl_set_id": [
          "bf265c2e-ab2f-42e5-96cf-3998eb5a644d"
        ],
        "package_ndc": [
          "65162-687-84"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175694",
          "M0002356"
        ],
        "pharm_class_epc": [
          "Benzodiazepine [EPC]"
        ],
        "pharm_class_cs": [
          "Benzodiazepines [CS]"
        ],
        "unii": [
          "O26FZP769L"
        ]
      },
      "product_type": "Drugs",
      "event_id": "77898",
      "recalling_firm": "Amneal Pharmaceuticals of New York, LLC",
      "address_1": "50 Horseblock Rd",
      "address_2": "",
      "postal_code": "11719-9509",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-0120-2018",
      "product_description": "Lorazepam Oral Concentrate, USP, 2 mg/mL, 30 mL bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Branchburg, NJ 08876. Distributed by: Amneal Pharmaceuticals, Glasgow, KY 42141. NDC 65162-687-84",
      "product_quantity": "136376 bottles",
      "reason_for_recall": "Defective Delivery System: the dropper measurement markings may be reversed, shifted or missing.",
      "recall_initiation_date": "20170803",
      "center_classification_date": "20171220",
      "termination_date": "20220907",
      "report_date": "20171227",
      "code_info": "Lot 06876016A, 06876017A, 06876018A, Exp 08/2018; 06876019A, 06876020A, 06876021A, 06876022A, Exp 09/2018; 06876023A, Exp 11/2018;  06876024A, 06876025A, Exp 12/2018; 06877001A, 06877002A, Exp 02/2019;  06877003A, Exp 03/2019.",
      "more_code_info": ""
    }
  ]
}