{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "East Windsor",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA206781"
        ],
        "brand_name": [
          "DEXAMETHASONE SODIUM PHOSPHATE"
        ],
        "generic_name": [
          "DEXAMETHASONE SODIUM PHOSPHATE"
        ],
        "manufacturer_name": [
          "Eugia US LLC"
        ],
        "product_ndc": [
          "55150-237",
          "55150-238",
          "55150-239"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRA-ARTICULAR",
          "INTRALESIONAL",
          "INTRAMUSCULAR",
          "INTRAVENOUS",
          "SOFT TISSUE"
        ],
        "substance_name": [
          "DEXAMETHASONE SODIUM PHOSPHATE"
        ],
        "rxcui": [
          "1116927",
          "1812194"
        ],
        "spl_id": [
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        ],
        "spl_set_id": [
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        ],
        "package_ndc": [
          "55150-237-01",
          "55150-238-05",
          "55150-239-30"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0355150239306",
          "0355150237012"
        ],
        "unii": [
          "AI9376Y64P"
        ]
      },
      "product_type": "Drugs",
      "event_id": "94685",
      "recalling_firm": "Eugia US LLC",
      "address_1": "279 Princeton Hightstown Rd",
      "address_2": "N/A",
      "postal_code": "08520-1401",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "USA Nationwide",
      "recall_number": "D-0555-2024",
      "product_description": "Dexamethasone Sodium Phosphate injection USP, 120mg per 30mL (4mg/mL), 30 mL Multiple-Dose Vial, Rx only, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520, Made in India, NDC 55150-239-30",
      "product_quantity": "70,125 vials",
      "reason_for_recall": "Failed Impurities/Degradation Specifications: impurity sulfonic acid adduct of dexamethasone phosphate results were above spec.",
      "recall_initiation_date": "20240523",
      "center_classification_date": "20240614",
      "report_date": "20240626",
      "code_info": "Lot#: 3DS23001, 3DS23004, Exp 6/30/2024; 3DS23009, 3DS23011, Exp 7/31/2024"
    }
  ]
}