{
  "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": "81925",
      "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 and Puerto Rico",
      "recall_number": "D-0390-2019",
      "product_description": "Fluocinolone Acetonide Topical Solution, USP, 0.01 %, 60 mL bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202; Manufactured by: Novel Laboratories, Inc., Somerset, NJ 08873; NDC 43386-069-60.",
      "product_quantity": "24,180 bottles",
      "reason_for_recall": "Failed Impurities/Degradation Specifications: Expansion of October 2018 recall due to elevated out of specification results for total impurities that have been chemically identified as oxidative degradation products of the fluocinolone active pharmaceutical ingredient.",
      "recall_initiation_date": "20190115",
      "center_classification_date": "20190123",
      "termination_date": "20230217",
      "report_date": "20190130",
      "code_info": "Lot #: S700214, Exp Apr-19; S700447, Exp Jun-19; S700787, Exp Oct-19; S701057, Exp Nov-19; S800107, Exp Feb-20; S800266, Exp Mar-20; S800524, Exp May-20; S800791, Exp  Jul-20"
    }
  ]
}