{
  "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,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Brockton",
      "state": "MA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA203378"
        ],
        "brand_name": [
          "FLUOCINOLONE ACETONIDE"
        ],
        "generic_name": [
          "FLUOCINOLONE ACETONIDE"
        ],
        "manufacturer_name": [
          "Rising Pharma Holdings, Inc."
        ],
        "product_ndc": [
          "64980-329"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "AURICULAR (OTIC)"
        ],
        "substance_name": [
          "FLUOCINOLONE ACETONIDE"
        ],
        "rxcui": [
          "1191299"
        ],
        "spl_id": [
          "4e01be19-15cd-4b8f-bbae-158c27b556f3"
        ],
        "spl_set_id": [
          "79591576-1eab-48c5-b0a6-e205b3cc097e"
        ],
        "package_ndc": [
          "64980-329-20",
          "3649803292"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0364980329200",
          "364980329200"
        ],
        "nui": [
          "N0000175576",
          "N0000175450"
        ],
        "pharm_class_epc": [
          "Corticosteroid [EPC]"
        ],
        "pharm_class_moa": [
          "Corticosteroid Hormone Receptor Agonists [MoA]"
        ],
        "unii": [
          "0CD5FD6S2M"
        ]
      },
      "product_type": "Drugs",
      "event_id": "79860",
      "recalling_firm": "Lyne Laboratories, Inc.",
      "address_1": "10 Burke Dr",
      "address_2": "N/A",
      "postal_code": "02301-5505",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "to be entered",
      "recall_number": "D-0712-2018",
      "product_description": "Fluocinolone Acetonide Topical Oil, 0.01% (Ear Drops) 20 mL, Rx Only, Manufactured by: Lyne Laboratories, Inc. Brockton, MA 02307 Manufactured for: Rising Pharmaceuticals, Inc. Allendale, NJ 07401, NDC 64980-329-20, UPC 364980329200",
      "product_quantity": "17939 units",
      "reason_for_recall": "Subpotent Drug",
      "recall_initiation_date": "20180413",
      "center_classification_date": "20180504",
      "termination_date": "20190516",
      "report_date": "20180502",
      "code_info": "Lot#: FR1604B, FR1604C, FR 1604D, Exp. 06/2018"
    }
  ]
}