{
  "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": "Hawthorne",
      "state": "NY",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA062364"
        ],
        "brand_name": [
          "NYSTATIN AND TRIAMCINOLONE ACETONIDE"
        ],
        "generic_name": [
          "NYSTATIN AND TRIAMCINOLONE ACETONIDE"
        ],
        "manufacturer_name": [
          "Sun Pharmaceutical Industries, Inc."
        ],
        "product_ndc": [
          "51672-1263",
          "51672-1272"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "NYSTATIN",
          "TRIAMCINOLONE ACETONIDE"
        ],
        "rxcui": [
          "1053697",
          "1053753"
        ],
        "spl_id": [
          "395e7f1c-ecc8-31cf-e063-6294a90aef62"
        ],
        "spl_set_id": [
          "2fd97fc5-cae5-43dd-a3c7-c9a03876153e"
        ],
        "package_ndc": [
          "51672-1272-1",
          "51672-1272-2",
          "51672-1272-3",
          "51672-1263-1",
          "51672-1263-2",
          "51672-1263-3"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175576",
          "N0000175450",
          "N0000175498",
          "M0017172"
        ],
        "pharm_class_epc": [
          "Corticosteroid [EPC]",
          "Polyene Antifungal [EPC]"
        ],
        "pharm_class_moa": [
          "Corticosteroid Hormone Receptor Agonists [MoA]"
        ],
        "pharm_class_cs": [
          "Polyenes [CS]"
        ],
        "unii": [
          "F446C597KA",
          "BDF1O1C72E"
        ]
      },
      "product_type": "Drugs",
      "event_id": "76954",
      "recalling_firm": "Taro Pharmaceuticals U.S.A., Inc.",
      "address_1": "3 Skyline Dr",
      "address_2": "N/A",
      "postal_code": "10532-2174",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide and Puerto Rico",
      "recall_number": "D-0676-2017",
      "product_description": "Nystatin and Triamcinolone Acetonide Cream, USP, 100,000 USP nystatin units and 1 mg triamcinolone acetonide, distributed in a) 15 grams (NDC 51672-1263-1), b) 30 grams (NDC 51672-1263-2)  and c) 60 grams (NDC 51672-1263-3) tubes, Rx only, TARO label;  Mfd. by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T 1C1 -- Dist. by: Taro Pharmaceuticals U.S.A. Inc., Hawthorne, NY 10532",
      "product_quantity": "278,304 tubes",
      "reason_for_recall": "Failed Content Uniformity Specifications; out-of-specification (OOS) results 18-month stability",
      "recall_initiation_date": "20170328",
      "center_classification_date": "20170420",
      "termination_date": "20190617",
      "report_date": "20170426",
      "code_info": "a) 15 g: Lot B505118501, exp. date January 2018;   b) 30 g: Lot B504918500, exp. date January 2018;  c) 60 g: Lots: I416616979, exp. date August 2017,                      I416716979, exp. date August 2017 and                     D504519119, exp. date March 2018"
    }
  ]
}