{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Eatontown",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA087702"
        ],
        "brand_name": [
          "DEXAMETHASONE SODIUM PHOSPHATE"
        ],
        "generic_name": [
          "DEXAMETHASONE SODIUM PHOSPHATE"
        ],
        "manufacturer_name": [
          "Hikma Pharmaceuticals USA Inc."
        ],
        "product_ndc": [
          "0641-0367",
          "0641-6145",
          "0641-6146"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAMUSCULAR",
          "INTRAVENOUS"
        ],
        "substance_name": [
          "DEXAMETHASONE SODIUM PHOSPHATE"
        ],
        "rxcui": [
          "309696",
          "1116927",
          "1812194"
        ],
        "spl_id": [
          "02bf3273-f0c8-448c-9f74-eb009fee9299"
        ],
        "spl_set_id": [
          "0277cc0a-2fd4-4605-a310-b613be84ee26"
        ],
        "package_ndc": [
          "0641-0367-21",
          "0641-0367-25",
          "0641-6145-01",
          "0641-6145-25",
          "0641-6146-01",
          "0641-6146-10",
          "0641-6146-25"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "AI9376Y64P"
        ]
      },
      "product_type": "Drugs",
      "event_id": "78415",
      "recalling_firm": "West-Ward Pharmaceuticals Corp.",
      "address_1": "401 Industrial Way West",
      "address_2": "N/A",
      "postal_code": "07724-2209",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA and Puerto Rico",
      "recall_number": "D-0094-2018",
      "product_description": "Dexamethasone Sodium Phosphate Injection, USP, 20 mg/5 mL (4 mg/mL), 5 mL Vials (NDC 0641-6146-01), packaged in 25 x 5 mL Vials per shelf pack (NDC 0641-6146-25), Rx Only, Manufactured by WEST-WARD, Eatontown, NJ 07724 USA.",
      "product_quantity": "1,896 shelf packs",
      "reason_for_recall": "Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound).",
      "recall_initiation_date": "20171106",
      "center_classification_date": "20171122",
      "termination_date": "20200401",
      "report_date": "20171129",
      "code_info": "Lot #: 106352, Exp 10/18"
    }
  ]
}