{
  "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": "Somerset",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA206422"
        ],
        "brand_name": [
          "FLUOCINOLONE ACETONIDE"
        ],
        "generic_name": [
          "FLUOCINOLONE ACETONIDE"
        ],
        "manufacturer_name": [
          "Lupin Pharmaceuticals,Inc."
        ],
        "product_ndc": [
          "43386-069"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "FLUOCINOLONE ACETONIDE"
        ],
        "rxcui": [
          "1191310"
        ],
        "spl_id": [
          "15764733-88e0-40bf-ac92-ff4e3e35b15d"
        ],
        "spl_set_id": [
          "460f5a55-6437-4651-bc08-8063ca579c8d"
        ],
        "package_ndc": [
          "43386-069-60"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0343386069606"
        ],
        "nui": [
          "N0000175576",
          "N0000175450"
        ],
        "pharm_class_epc": [
          "Corticosteroid [EPC]"
        ],
        "pharm_class_moa": [
          "Corticosteroid Hormone Receptor Agonists [MoA]"
        ],
        "unii": [
          "0CD5FD6S2M"
        ]
      },
      "product_type": "Drugs",
      "event_id": "81168",
      "recalling_firm": "LUPIN SOMERSET",
      "address_1": "400 Campus Dr",
      "address_2": "N/A",
      "postal_code": "08873-1145",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0092-2019",
      "product_description": "Fluocinolone Acetonide Topical Solution, USP 0.01%, 60ml Bottle, Manufactured for: Lupin Pharmaceutical, Inc. Baltimore, MD 21202 Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873. NDC  43386-069-60",
      "product_quantity": "2712 60-ml bottles",
      "reason_for_recall": "Failed Impurities/Degradation Specifications:Out of specification result noticed for total impurities observed during stability analysis",
      "recall_initiation_date": "20181005",
      "center_classification_date": "20181024",
      "termination_date": "20221108",
      "report_date": "20181031",
      "code_info": "Lot# M16666, EXP 12/2018"
    }
  ]
}