{
  "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": [
    {
      "country": "United States",
      "city": "North Wales",
      "address_1": "1090 Horsham Rd",
      "reason_for_recall": "Failed Impurities and Degradation Specifications and Subpotent Drug: out-of-specification (OOS) test results for below assay and above specification for degradants.",
      "address_2": "",
      "product_quantity": "27,803 bottles",
      "code_info": "Lot #s: 1164898, EXP 10/18; 1164904, 1164909, EXP 11/18; 1211396, EXP 07/19; 1230808, 1231127, EXP 01/20",
      "center_classification_date": "20180706",
      "distribution_pattern": "Nationwide in the USA and Puerto Rico",
      "state": "PA",
      "product_description": "Fluocinolone Acetonide Topical Solution, USP, 0.01%, 60 mL  bottle, Rx Only, Manufactured by: Actavis Laboratories UT, Inc., Salt Lake City, UT  84108 USA; Distributed by: Actavis Pharmac, Inc., Parsippany, NJ  07054 USA, NDC 0591-2990-60.",
      "report_date": "20180718",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA208386"
        ],
        "brand_name": [
          "FLUOCINOLONE ACETONIDE TOPICAL"
        ],
        "generic_name": [
          "FLUOCINOLONE ACETONIDE TOPICAL"
        ],
        "manufacturer_name": [
          "Actavis Pharma, Inc."
        ],
        "product_ndc": [
          "0591-2990"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "FLUOCINOLONE ACETONIDE"
        ],
        "rxcui": [
          "1191310"
        ],
        "spl_id": [
          "8c1b96a1-47e6-4fac-9bda-0b299ac25800"
        ],
        "spl_set_id": [
          "98dfd7a4-2208-4637-acf5-080a5813a433"
        ],
        "package_ndc": [
          "0591-2990-60"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175576",
          "N0000175450"
        ],
        "pharm_class_epc": [
          "Corticosteroid [EPC]"
        ],
        "pharm_class_moa": [
          "Corticosteroid Hormone Receptor Agonists [MoA]"
        ],
        "unii": [
          "0CD5FD6S2M"
        ]
      },
      "recalling_firm": "Teva Pharmaceuticals USA",
      "recall_number": "D-0909-2018",
      "initial_firm_notification": "Letter",
      "product_type": "Drugs",
      "event_id": "80437",
      "termination_date": "20190403",
      "more_code_info": "",
      "recall_initiation_date": "20180705",
      "postal_code": "19454-1505",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}