{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Bridgewater",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "NDA012750"
        ],
        "brand_name": [
          "LIBRAX"
        ],
        "generic_name": [
          "CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE"
        ],
        "manufacturer_name": [
          "Bausch Health US, LLC"
        ],
        "product_ndc": [
          "0187-4100"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "CHLORDIAZEPOXIDE HYDROCHLORIDE",
          "CLIDINIUM BROMIDE"
        ],
        "rxcui": [
          "889614",
          "889616"
        ],
        "spl_id": [
          "98fd8b52-2fc3-4540-8333-75b5c853aee2"
        ],
        "spl_set_id": [
          "f99ebf66-f207-4a97-9666-4da1d72b061c"
        ],
        "package_ndc": [
          "0187-4100-10"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0301874100101"
        ],
        "unii": [
          "MFM6K1XWDK",
          "91ZQW5JF1Z"
        ]
      },
      "product_type": "Drugs",
      "event_id": "70112",
      "recalling_firm": "Valeant Pharmaceuticals North America LLC",
      "address_1": "400 Somerset Corporate Blvd",
      "address_2": "",
      "postal_code": "08807-2867",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide and Puerto Rico",
      "recall_number": "D-1034-2016",
      "product_description": "Librax (5 mg chlordiazepoxide HCl and 2.5 mg clidinium bromide) capsules, 100-count bottle, Rx Only, Manufactured in Canada by: Valeant Pharmaceuticals International, Inc., Steinbach, MB R5G 1Z7 Canada;  Manufactured for: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807, NDC 0187-4100-10.",
      "product_quantity": "6,321 bottles",
      "reason_for_recall": "Failed Impurities/Degradation Specifications",
      "recall_initiation_date": "20150418",
      "center_classification_date": "20160616",
      "termination_date": "20170613",
      "report_date": "20160622",
      "code_info": "Lot #: 14L024P, Exp 06/16; and 15E029P, Exp 04/19",
      "more_code_info": ""
    }
  ]
}