{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
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    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Somerset",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "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"
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        "substance_name": [
          "FLUOCINOLONE ACETONIDE"
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        "rxcui": [
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        "package_ndc": [
          "43386-069-60"
        ],
        "is_original_packager": [
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        "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": "76231",
      "recalling_firm": "Novel Laboratories, Inc.",
      "address_1": "390 & 400 Campus Drive",
      "address_2": "N/A",
      "postal_code": "08873-1145",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-0653-2017",
      "product_description": "Fluocinolone Acetonide Topical Solution USP 0.01% For Topical Use Only, Not for Ophthalmic Use,  60 mL bottle, Rx Only, Manufactured for Gavis Pharmaceuticals, LLC, Somerset NJ 08873,   Manufactured by Novel Laboratories, Inc. Somerset, NJ 08873, NDC  43386-069-60",
      "product_quantity": "7,656 bottles",
      "reason_for_recall": "Chemical Contamination",
      "recall_initiation_date": "20170222",
      "center_classification_date": "20170411",
      "termination_date": "20190819",
      "report_date": "20170419",
      "code_info": "Lot # M15496; Exp. 10/17  Lot # M15507; Exp. 12/17",
      "more_code_info": ""
    }
  ]
}