{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Bronx",
      "state": "NY",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA078594"
        ],
        "brand_name": [
          "CICLOPIROX"
        ],
        "generic_name": [
          "CICLOPIROX"
        ],
        "manufacturer_name": [
          "Padagis Israel Pharmaceuticals Ltd"
        ],
        "product_ndc": [
          "45802-401"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "CICLOPIROX"
        ],
        "rxcui": [
          "250344"
        ],
        "spl_id": [
          "f9c45e64-a8ae-4bc5-9d1f-40eac9847c55"
        ],
        "spl_set_id": [
          "c3722d52-407c-499b-a08b-b299609f203c"
        ],
        "package_ndc": [
          "45802-401-09"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000008577",
          "N0000008841",
          "N0000008853",
          "N0000000150"
        ],
        "pharm_class_pe": [
          "Decreased DNA Replication [PE]",
          "Decreased Protein Synthesis [PE]",
          "Decreased RNA Replication [PE]"
        ],
        "pharm_class_moa": [
          "Protein Synthesis Inhibitors [MoA]"
        ],
        "unii": [
          "19W019ZDRJ"
        ]
      },
      "product_type": "Drugs",
      "event_id": "82127",
      "recalling_firm": "Perrigo New York, Inc.",
      "address_1": "1700 Bathgate Ave",
      "address_2": "",
      "postal_code": "10457-7512",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide within the United States",
      "recall_number": "D-0512-2019",
      "product_description": "Ciclopirox shampoo 1%,120 mL bottle, Rx only, Manufactured By Perrigo Bronx, NY 10457 Distributed by Perrigo Allegan, MI 49010, 45802-401-09",
      "product_quantity": "12252 bottles",
      "reason_for_recall": "Failed Degradation/Impurities Specifications: Out of specification related substance results during stability testing.",
      "recall_initiation_date": "20190213",
      "center_classification_date": "20190220",
      "termination_date": "20210908",
      "report_date": "20190227",
      "code_info": "Lot #: 7DT0280, 7ET0565, Exp. 02/19",
      "more_code_info": ""
    }
  ]
}