{
  "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": "Greenville",
      "state": "NC",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "NDA202428"
        ],
        "brand_name": [
          "FABIOR"
        ],
        "generic_name": [
          "TAZAROTENE"
        ],
        "manufacturer_name": [
          "Mayne Pharma"
        ],
        "product_ndc": [
          "51862-295"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "TAZAROTENE"
        ],
        "rxcui": [
          "1293451",
          "1293456"
        ],
        "spl_id": [
          "4c23641b-0092-4d63-e063-6394a90aa62e"
        ],
        "spl_set_id": [
          "ae0afed7-1d60-45fd-a08b-8db094618521"
        ],
        "package_ndc": [
          "51862-295-50",
          "51862-295-10"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175607",
          "M0018962"
        ],
        "pharm_class_epc": [
          "Retinoid [EPC]"
        ],
        "pharm_class_cs": [
          "Retinoids [CS]"
        ],
        "unii": [
          "81BDR9Y8PS"
        ]
      },
      "product_type": "Drugs",
      "event_id": "79604",
      "recalling_firm": "Mayne Pharma Inc",
      "address_1": "1240 Sugg Pkwy",
      "address_2": "N/A",
      "postal_code": "27834-9006",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0616-2018",
      "product_description": "Fabior (tazarotene) Foam, 0.1%, 100 grams can, Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834; NDC 51862-295-10.",
      "product_quantity": "3312 cans",
      "reason_for_recall": "Superpotent Drug: High out of specification results for tazarotene assay at the 9-month stability time point.",
      "recall_initiation_date": "20180321",
      "center_classification_date": "20180330",
      "termination_date": "20200611",
      "report_date": "20180411",
      "code_info": "Lot: MBEB, Exp. 01/31/2019"
    }
  ]
}