{
  "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": "Malvern",
      "state": "PA",
      "country": "United States",
      "classification": "Class I",
      "openfda": {
        "application_number": [
          "ANDA077171"
        ],
        "brand_name": [
          "CLONAZEPAM"
        ],
        "generic_name": [
          "CLONAZEPAM"
        ],
        "manufacturer_name": [
          "Par Health USA, LLC"
        ],
        "product_ndc": [
          "49884-306",
          "49884-307",
          "49884-308",
          "49884-309",
          "49884-310"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "CLONAZEPAM"
        ],
        "rxcui": [
          "349194",
          "349195",
          "349196",
          "349197",
          "349198"
        ],
        "spl_id": [
          "cb847105-dbbe-4e7a-ab2b-ad0731638ce6"
        ],
        "spl_set_id": [
          "1aef0069-80ea-483d-ac70-c8d485462c5b"
        ],
        "package_ndc": [
          "49884-306-02",
          "49884-307-02",
          "49884-308-02",
          "49884-309-02",
          "49884-310-02",
          "49884-310-52"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175694",
          "M0002356"
        ],
        "pharm_class_epc": [
          "Benzodiazepine [EPC]"
        ],
        "pharm_class_cs": [
          "Benzodiazepines [CS]"
        ],
        "unii": [
          "5PE9FDE8GB"
        ]
      },
      "product_type": "Drugs",
      "event_id": "95778",
      "recalling_firm": "Endo USA, Inc.",
      "address_1": "1400 Atwater Dr",
      "address_2": "",
      "postal_code": "19355-8701",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Press Release",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0178-2025",
      "product_description": "Clonazepam Orally Disintegrating Tablet, USP, 2 mg, C-IV, Rx Only, 60 Tablets per carton, 10 blister cards containing 6 tablets each, Distributed by: PAR Pharmaceutical, Chestnut Ridge, NY 10977, NDC#: 49884-310-02 (carton), NDC#: 49884-310-52 (blisters).",
      "product_quantity": "9,816 cartons",
      "reason_for_recall": "Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.",
      "recall_initiation_date": "20241118",
      "center_classification_date": "20250103",
      "report_date": "20250115",
      "code_info": "Lot # 550176501, 550176601, Exp 02/28/2027.",
      "more_code_info": ""
    }
  ]
}