{
  "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": "Plainsboro",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA202929"
        ],
        "brand_name": [
          "ESZOPICLONE"
        ],
        "generic_name": [
          "ESZOPICLONE"
        ],
        "manufacturer_name": [
          "Macleods Pharmaceuticals Limited"
        ],
        "product_ndc": [
          "33342-299",
          "33342-300",
          "33342-301"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ESZOPICLONE"
        ],
        "rxcui": [
          "485440",
          "485442",
          "485465"
        ],
        "spl_id": [
          "66cfec66-191e-4af9-a623-8464417fab6d"
        ],
        "spl_set_id": [
          "12593790-e72f-45b1-8895-987cdd075134"
        ],
        "package_ndc": [
          "33342-299-07",
          "33342-299-11",
          "33342-299-44",
          "33342-299-12",
          "33342-300-11",
          "33342-300-44",
          "33342-300-12",
          "33342-301-11",
          "33342-301-44",
          "33342-301-12"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0333342300119",
          "0333342299079",
          "0333342301116"
        ],
        "unii": [
          "UZX80K71OE"
        ]
      },
      "product_type": "Drugs",
      "event_id": "90444",
      "recalling_firm": "Macleods Pharma Usa Inc",
      "address_1": "666 Plainsboro Rd Bldg 200 Ste 230",
      "address_2": "N/A",
      "postal_code": "08536-0009",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Distributed Nationwide and Puerto Rico.",
      "recall_number": "D-1174-2022",
      "product_description": "Eszopiclone Tablets, USP 1 mg,  packaged in 30-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, Himachal Pradesh, INDIA, NDC 33342-299-07",
      "product_quantity": "168690 Tablets",
      "reason_for_recall": "Shortfill: customer complaints of one to three tablets were reported missing from 30 count bottles.",
      "recall_initiation_date": "20220616",
      "center_classification_date": "20220705",
      "termination_date": "20240320",
      "report_date": "20220713",
      "code_info": "Lot #: BEK2009A Exp: 11/2023",
      "more_code_info": ""
    }
  ]
}