{
  "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": "2026-06-03",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Somerset",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA211036"
        ],
        "brand_name": [
          "DEXAMETHASONE SODIUM PHOSPHATE"
        ],
        "generic_name": [
          "DEXAMETHASONE SODIUM PHOSPHATE"
        ],
        "manufacturer_name": [
          "Somerset Therapeutics, LLC"
        ],
        "product_ndc": [
          "70069-025"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAMUSCULAR",
          "INTRAVENOUS"
        ],
        "substance_name": [
          "DEXAMETHASONE SODIUM PHOSPHATE"
        ],
        "rxcui": [
          "309696"
        ],
        "spl_id": [
          "0fefe630-0e29-4d04-a083-eb3036f48100"
        ],
        "spl_set_id": [
          "5a1b0266-90c8-4176-a6b0-c4204d3c604e"
        ],
        "package_ndc": [
          "70069-025-10",
          "70069-025-01"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0370069025109",
          "0370069025017"
        ],
        "unii": [
          "AI9376Y64P"
        ]
      },
      "product_type": "Drugs",
      "event_id": "98388",
      "recalling_firm": "SOMERSET THERAPEUTICS LLC",
      "address_1": "300 Franklin Square Dr",
      "address_2": "N/A",
      "postal_code": "08873-4187",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0398-2026",
      "product_description": "Dexamethasone Sodium Phosphate Injection, USP, 100 mg/ 10 mL, (10 mg/mL), 10x10 mL Multiple Dose Vials, Rx only, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873, NDC carton: 70069-025-10; NDC vial: 70069-025-01",
      "product_quantity": "62190 vials",
      "reason_for_recall": "Failed Impurities/Degradation Specifications - OOS impurities result observed during long term stability testing at product expiry (24 months) were above specs for these impurities: Dexamethasone Sodium Phosphate EP impurity G (Impurity RU 49336) and dexamethasone formate.",
      "recall_initiation_date": "20260204",
      "center_classification_date": "20260318",
      "report_date": "20260325",
      "code_info": "Lot #: A240421, Exp 07/31/2026",
      "more_code_info": ""
    }
  ]
}