{
  "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": [
          "0641-6048",
          "0641-6050",
          "0641-6049",
          "0641-6051"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAMUSCULAR",
          "INTRAVENOUS"
        ],
        "substance_name": [
          "LORAZEPAM"
        ],
        "rxcui": [
          "238100",
          "238101",
          "1665188",
          "1665326"
        ],
        "spl_id": [
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        ],
        "spl_set_id": [
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        ],
        "package_ndc": [
          "0641-6048-01",
          "0641-6048-25",
          "0641-6050-01",
          "0641-6050-10",
          "0641-6049-01",
          "0641-6049-25",
          "0641-6051-01",
          "0641-6051-10"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175694",
          "M0002356"
        ],
        "pharm_class_epc": [
          "Benzodiazepine [EPC]"
        ],
        "pharm_class_cs": [
          "Benzodiazepines [CS]"
        ],
        "unii": [
          "O26FZP769L"
        ]
      },
      "product_type": "Drugs",
      "event_id": "90583",
      "recalling_firm": "Hikma Pharmaceuticals USA Inc.",
      "address_1": "2 Esterbrook Ln",
      "address_2": "",
      "postal_code": "08003-4002",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-1309-2022",
      "product_description": "Lorazepam Injection, USP, 2mg/mL, 1 mL vial,  25 vial per carton, Rx Only, Novaplus, Manufactured by Hikma Berkeley Heights, NJ 07922. Carton NDC# 0641-6048-25, Vial NDC# 0641-6048-01",
      "product_quantity": "713,550 vials",
      "reason_for_recall": "Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.",
      "recall_initiation_date": "20220711",
      "center_classification_date": "20220805",
      "termination_date": "20230914",
      "report_date": "20220817",
      "code_info": "Lot # 070088, exp. date 07/2023",
      "more_code_info": ""
    }
  ]
}