{
  "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": "Bridgewater",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "NDA020648"
        ],
        "brand_name": [
          "DIAZEPAM"
        ],
        "generic_name": [
          "DIAZEPAM"
        ],
        "manufacturer_name": [
          "Oceanside Pharmaceuticals"
        ],
        "product_ndc": [
          "68682-650",
          "68682-652",
          "68682-655"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "RECTAL"
        ],
        "substance_name": [
          "DIAZEPAM"
        ],
        "rxcui": [
          "801957",
          "801961",
          "801966"
        ],
        "spl_id": [
          "0e23d654-d8b9-af1c-e063-6294a90a6f14"
        ],
        "spl_set_id": [
          "b1b2848b-b265-4f6f-9141-bf106dec0726"
        ],
        "package_ndc": [
          "68682-652-20",
          "68682-655-20",
          "68682-650-20"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175694",
          "M0002356"
        ],
        "pharm_class_epc": [
          "Benzodiazepine [EPC]"
        ],
        "pharm_class_cs": [
          "Benzodiazepines [CS]"
        ],
        "unii": [
          "Q3JTX2Q7TU"
        ]
      },
      "product_type": "Drugs",
      "event_id": "80662",
      "recalling_firm": "Valeant Pharmaceuticals North America LLC",
      "address_1": "400 Somerset Corporate Blvd",
      "address_2": "N/A",
      "postal_code": "08807-2867",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-1041-2018",
      "product_description": "Diazepam Rectal Gel, 2.5 mg, TWIN PACK that Contains two pre-filled, unit-dose, rectal delivery systems with lubricating jelly and instructions for use per carton, Rx only, Manufactured for: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ  08807; Manufactured by: DPT Laboratories, Ltd., San Antonio, TX  78215; NDC 68682-650-20.",
      "product_quantity": "306 cartons",
      "reason_for_recall": "Labeling: Incorrect or Missing Lot and/or Exp Date: Product distributed without a lot number or expiration date on the outer carton.",
      "recall_initiation_date": "20180710",
      "center_classification_date": "20180803",
      "termination_date": "20190205",
      "report_date": "20180815",
      "code_info": "Lot #: NBBN, Exp 02/22"
    }
  ]
}