{
  "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": "Brampton",
      "state": "",
      "country": "Canada",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA088759"
        ],
        "brand_name": [
          "HYDROCORTISONE AND ACETIC ACID"
        ],
        "generic_name": [
          "HYDROCORTISONE AND ACETIC ACID"
        ],
        "manufacturer_name": [
          "Sun Pharmaceutical Industries, Inc."
        ],
        "product_ndc": [
          "51672-3007"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "AURICULAR (OTIC)"
        ],
        "substance_name": [
          "HYDROCORTISONE",
          "ACETIC ACID"
        ],
        "spl_id": [
          "395a20ab-856b-3f08-e063-6294a90aa48e"
        ],
        "spl_set_id": [
          "6383c722-84e2-4719-a13d-19c54e3eefff"
        ],
        "package_ndc": [
          "51672-3007-1"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175576",
          "N0000175450"
        ],
        "pharm_class_epc": [
          "Corticosteroid [EPC]"
        ],
        "pharm_class_moa": [
          "Corticosteroid Hormone Receptor Agonists [MoA]"
        ],
        "unii": [
          "WI4X0X7BPJ",
          "Q40Q9N063P"
        ]
      },
      "product_type": "Drugs",
      "event_id": "93337",
      "recalling_firm": "Taro Pharmaceuticals Inc.",
      "address_1": "130 East Dr",
      "address_2": "",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0089-2024",
      "product_description": "Hydrocortisone 1% and Acetic Acid 2% Otic Solution USP, 10ml dropper bottle, RX Only, Mfd. by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada LGT 1C, Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532. NDC 51672-3007-1",
      "product_quantity": "11,196 bottles",
      "reason_for_recall": "Failed Impurities/Degradation Specifications:Out-of-Specification result for Hydrocortisone related impurity and slightly lower than the established level of the Hydrocortisone Assay obtained during stability testing.",
      "recall_initiation_date": "20231106",
      "center_classification_date": "20231106",
      "termination_date": "20240827",
      "report_date": "20231115",
      "code_info": "Lot# AC86809, AC86812, Exp Date: 01/31/2024",
      "more_code_info": ""
    }
  ]
}