{
  "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": "Ongoing",
      "city": "East Brunswick",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA207440"
        ],
        "brand_name": [
          "DIFLORASONE DIACETATE"
        ],
        "generic_name": [
          "DIFLORASONE DIACETATE"
        ],
        "manufacturer_name": [
          "Rising Pharma Holdings, Inc."
        ],
        "product_ndc": [
          "64980-124"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "TOPICAL"
        ],
        "substance_name": [
          "DIFLORASONE DIACETATE"
        ],
        "rxcui": [
          "966607"
        ],
        "spl_id": [
          "0cc31fd1-b6fb-44d0-a911-b4c11ce12c4b"
        ],
        "spl_set_id": [
          "23eb27a4-157f-4eb5-a390-37586710808f"
        ],
        "package_ndc": [
          "64980-124-15",
          "64980-124-03",
          "64980-124-45",
          "64980-124-60"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "7W2J09SCWX"
        ]
      },
      "product_type": "Drugs",
      "event_id": "94854",
      "recalling_firm": "Rising Pharma Holding, Inc.",
      "address_1": "2 Tower Center Blvd Ste 1401",
      "address_2": "N/A",
      "postal_code": "08816-1149",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0599-2024",
      "product_description": "Diflorasone Diacetate Ointment, USP, 0.05%, 60g tube, Rx only, Mfd. By: Lyne Laboratories, Inc., Brockton, MA 02301; Mfd. For: Rising Pharmaceuticals, Inc., East Brunswick, NJ 08816 NDC 64980-124-60",
      "product_quantity": "868 tubes",
      "reason_for_recall": "Failed Impurities/Degradation Specifications:  The impurity results at 12 months stability testing,did not conform to the specification limit.",
      "recall_initiation_date": "20240624",
      "center_classification_date": "20240716",
      "report_date": "20240717",
      "code_info": "Lot #, DI2303B, Exp 12/31/2024"
    }
  ]
}