{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "East Windsor",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA071858"
        ],
        "brand_name": [
          "CLORAZEPATE DIPOTASSIUM"
        ],
        "generic_name": [
          "CLORAZEPATE DIPOTASSIUM"
        ],
        "manufacturer_name": [
          "Aurolife Pharma LLC"
        ],
        "product_ndc": [
          "13107-282",
          "13107-283",
          "13107-284"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "CLORAZEPATE DIPOTASSIUM"
        ],
        "rxcui": [
          "197464",
          "197465",
          "197466"
        ],
        "spl_id": [
          "69451c35-dd9a-4690-8d5e-4dcfa8837620"
        ],
        "spl_set_id": [
          "69451c35-dd9a-4690-8d5e-4dcfa8837620"
        ],
        "package_ndc": [
          "13107-282-01",
          "13107-282-05",
          "13107-283-01",
          "13107-283-05",
          "13107-284-01"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "63FN7G03XY"
        ]
      },
      "product_type": "Drugs",
      "event_id": "94500",
      "recalling_firm": "Aurobindo Pharma USA Inc.",
      "address_1": "279 Princeton Hightstown Rd",
      "address_2": "N/A",
      "postal_code": "08520-1401",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0491-2024",
      "product_description": "Clorazepate Dipotassium Tablets, USP, 3.75 mg, a) 100 tablets per bottle, NDC 13107-282-01 b) 500 tablets per bottle, NDC 13107-282-05, Rx Only, Distributed by Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India.",
      "product_quantity": "6696 bottles",
      "reason_for_recall": "Discoloration: Dotted and yellow spots on tablets",
      "recall_initiation_date": "20240424",
      "center_classification_date": "20240508",
      "report_date": "20240515",
      "code_info": "Lot #s: a) CZA124001B, CZA124002B, CZA124003B, Exp. 12/31/2025; b) CZA124001A, CZA124003A, Exp. 12/31/2025."
    }
  ]
}