{
  "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": "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"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175694",
          "M0002356"
        ],
        "pharm_class_epc": [
          "Benzodiazepine [EPC]"
        ],
        "pharm_class_cs": [
          "Benzodiazepines [CS]"
        ],
        "unii": [
          "5PE9FDE8GB"
        ]
      },
      "product_type": "Drugs",
      "event_id": "94945",
      "recalling_firm": "Endo Pharmaceuticals, Inc.",
      "address_1": "1400 Atwater Dr",
      "address_2": "N/A",
      "postal_code": "19355-8701",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA and Puerto Rico",
      "recall_number": "D-0622-2024",
      "product_description": "Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.125mg, 60 tablets per carton (10 blister cards containing 6 tablets each), Rx Only, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC# 49884-306-02.",
      "product_quantity": "8,139 cartons",
      "reason_for_recall": "Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled as 0.125 mg instead of 0.25 mg. The blister strips inside the product carton reflect the correct strength of 0.25 mg.",
      "recall_initiation_date": "20240710",
      "center_classification_date": "20240730",
      "termination_date": "20250916",
      "report_date": "20240807",
      "code_info": "Lot 550147301, Exp. 08/31/2026"
    }
  ]
}