{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Eatontown",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA078215"
        ],
        "brand_name": [
          "SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE"
        ],
        "generic_name": [
          "SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE"
        ],
        "manufacturer_name": [
          "Hikma Pharmaceuticals USA Inc."
        ],
        "product_ndc": [
          "0143-9570"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "SODIUM FERRIC GLUCONATE COMPLEX"
        ],
        "rxcui": [
          "242761"
        ],
        "spl_id": [
          "7a57fb1e-f803-4f81-a643-6fc18d8371ff"
        ],
        "spl_set_id": [
          "218d1b8d-b24f-4f77-b588-97c7dd1c2eec"
        ],
        "package_ndc": [
          "0143-9570-01",
          "0143-9570-10"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "M0011718",
          "N0000177913"
        ],
        "pharm_class_cs": [
          "Iron [CS]"
        ],
        "pharm_class_epc": [
          "Parenteral Iron Replacement [EPC]"
        ],
        "unii": [
          "CC9149U2QX"
        ]
      },
      "product_type": "Drugs",
      "event_id": "75784",
      "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": "US nationwide",
      "recall_number": "D-0172-2017",
      "product_description": "SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE INJECTION, 62.5mg elemental iron/5mL, 10 (5mL vials) per shelf pack, Rx only,  Mfd: Hikma Farmaceutica (Portugal,) SA   Distributed by: Westward Eatowntown NJ  07724 USA, Shelf pack NDC 0143-9570-10, Unit dose NDC 0143-9570-01",
      "product_quantity": "5,142 Shelf-packs",
      "reason_for_recall": "Subpotent Drug: Product has an an out of specification in iron assay analysis found during 18 month stability testing.",
      "recall_initiation_date": "20161117",
      "center_classification_date": "20161208",
      "termination_date": "20180419",
      "report_date": "20161214",
      "code_info": "Lot #: 152032.1, Exp. Date. 2/2017"
    }
  ]
}