{
  "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": "2026-07-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Hawthorne",
      "state": "NY",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA075673"
        ],
        "brand_name": [
          "CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE"
        ],
        "generic_name": [
          "CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE"
        ],
        "manufacturer_name": [
          "Sun Pharmaceutical Industries, Inc."
        ],
        "product_ndc": [
          "51672-4048"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "CLOTRIMAZOLE",
          "BETAMETHASONE DIPROPIONATE"
        ],
        "rxcui": [
          "308714"
        ],
        "spl_id": [
          "56999a29-6571-de88-e063-6394a90aac84"
        ],
        "spl_set_id": [
          "1c18e5fc-bf82-47bc-bfd9-8d3e503569ba"
        ],
        "package_ndc": [
          "51672-4048-1",
          "51672-4048-6"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175487",
          "M0002083"
        ],
        "pharm_class_epc": [
          "Azole Antifungal [EPC]"
        ],
        "pharm_class_cs": [
          "Azoles [CS]"
        ],
        "unii": [
          "G07GZ97H65",
          "826Y60901U"
        ]
      },
      "product_type": "Drugs",
      "event_id": "89678",
      "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": "Product was distributed to one retail consignee in NY.",
      "recall_number": "D-0727-2022",
      "product_description": "Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05%,15 g tubes, Rx only, Manufactured by: Taro Pharmaceuticals Industries Ltd. Haifa Bay, Israel 2624761, Distributed by: Taro Pharmaceuticals U.S.A., Inc.  Hawthorne, NY 10532, NDC 51672-4048-1",
      "product_quantity": "768 tubes",
      "reason_for_recall": "Failed Content Uniformity Specifications: Out-of-specification result for the Betamethasone Dipropionate assay of a stability sample",
      "recall_initiation_date": "20220225",
      "center_classification_date": "20220329",
      "termination_date": "20240909",
      "report_date": "20220406",
      "code_info": "Lot #: AC33883, Exp. Date June 2023"
    }
  ]
}