{
  "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": "Ongoing",
      "city": "Princeton",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA091024"
        ],
        "brand_name": [
          "ESZOPICLONE"
        ],
        "generic_name": [
          "ESZOPICLONE"
        ],
        "manufacturer_name": [
          "Dr. Reddy's Laboratories Limited"
        ],
        "product_ndc": [
          "55111-617",
          "55111-629",
          "55111-619"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ESZOPICLONE"
        ],
        "rxcui": [
          "485440",
          "485442",
          "485465"
        ],
        "spl_id": [
          "bf1433f5-bde8-8c67-9ff7-ec5d3ed26581"
        ],
        "spl_set_id": [
          "0b363b90-93dc-1fc1-0501-d140dfc762c7"
        ],
        "package_ndc": [
          "55111-629-30",
          "55111-629-01",
          "55111-629-05",
          "55111-619-30",
          "55111-619-90",
          "55111-619-01",
          "55111-619-05",
          "55111-619-79",
          "55111-619-09",
          "55111-617-30",
          "55111-617-90",
          "55111-617-01",
          "55111-617-05",
          "55111-617-79",
          "55111-617-09"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0355111617013",
          "0355111629306",
          "0355111619017"
        ],
        "unii": [
          "UZX80K71OE"
        ]
      },
      "product_type": "Drugs",
      "event_id": "94754",
      "recalling_firm": "Dr. Reddy's Laboratories, Inc.",
      "address_1": "107 College Rd E",
      "address_2": "N/A",
      "postal_code": "08540-6623",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "N/A",
      "distribution_pattern": "OH, MS",
      "recall_number": "D-0581-2024",
      "product_description": "Eszopiclone Tablets, USP 1mg CIV, 30-count bottle, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, NDC 55111-629-30",
      "product_quantity": "13,752 bottles",
      "reason_for_recall": "Failed Impurities/Degradation Specifications: Related Substances",
      "recall_initiation_date": "20240604",
      "center_classification_date": "20240702",
      "report_date": "20240710",
      "code_info": "Lot#: C2302598, Exp 2/29/2025"
    }
  ]
}