{
  "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": "Cherry Hill",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "NDA018140"
        ],
        "brand_name": [
          "LORAZEPAM"
        ],
        "generic_name": [
          "LORAZEPAM"
        ],
        "manufacturer_name": [
          "Hikma Pharmaceuticals USA Inc."
        ],
        "product_ndc": [
          "0641-6044",
          "0641-6046",
          "0641-6045",
          "0641-6047"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAMUSCULAR",
          "INTRAVENOUS"
        ],
        "substance_name": [
          "LORAZEPAM"
        ],
        "rxcui": [
          "238100",
          "238101",
          "1665188",
          "1665326"
        ],
        "spl_id": [
          "7c73dbc6-2623-4443-9b05-97dec7a0be2e"
        ],
        "spl_set_id": [
          "e9b54e42-04cf-4c62-90e1-36f7b31a4e81"
        ],
        "package_ndc": [
          "0641-6044-01",
          "0641-6044-25",
          "0641-6046-01",
          "0641-6046-10",
          "0641-6045-01",
          "0641-6045-25",
          "0641-6047-01",
          "0641-6047-10"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175694",
          "M0002356"
        ],
        "pharm_class_epc": [
          "Benzodiazepine [EPC]"
        ],
        "pharm_class_cs": [
          "Benzodiazepines [CS]"
        ],
        "unii": [
          "O26FZP769L"
        ]
      },
      "product_type": "Drugs",
      "event_id": "92320",
      "recalling_firm": "Hikma Pharmaceuticals USA Inc.",
      "address_1": "2 Esterbrook Ln",
      "address_2": "N/A",
      "postal_code": "08003-4002",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA and Puerto Rico",
      "recall_number": "D-0574-2023",
      "product_description": "Lorazepam Injection, USP, 2mg/mL, 1 mL vial (NDC 0641-6044-01), packaged in 25 x 1 mL Vials per carton (NDC 0641-6044-25), Rx only, Manufactured by West-Ward, Eatontown, NJ 07724.",
      "product_quantity": "1,352,475 vials",
      "reason_for_recall": "Failed Impurities/Degradation Specifications: Out-of-specification results for total related compounds observed during retain steting due to the elevated Related Compound-C.",
      "recall_initiation_date": "20230511",
      "center_classification_date": "20230515",
      "termination_date": "20231212",
      "report_date": "20230524",
      "code_info": "Lots:  070086, 070128, Exp. 07/2023"
    }
  ]
}