{
  "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": "2026-07-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Eatontown",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA078765"
        ],
        "brand_name": [
          "FOSPHENYTOIN SODIUM"
        ],
        "generic_name": [
          "FOSPHENYTOIN SODIUM"
        ],
        "manufacturer_name": [
          "West-Ward Pharmaceuticals Corp"
        ],
        "product_ndc": [
          "0143-9788",
          "0143-9782"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAMUSCULAR",
          "INTRAVENOUS"
        ],
        "substance_name": [
          "FOSPHENYTOIN SODIUM"
        ],
        "rxcui": [
          "1670195",
          "1670200"
        ],
        "spl_id": [
          "6b56fe59-9fb1-410b-b57c-7ada1662136a"
        ],
        "spl_set_id": [
          "c92df63b-5140-4213-8d43-8327ff6230b7"
        ],
        "package_ndc": [
          "0143-9788-01",
          "0143-9788-25",
          "0143-9782-01",
          "0143-9782-10",
          "0143-9703-10"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "7VLR55452Z"
        ]
      },
      "product_type": "Drugs",
      "event_id": "62627",
      "recalling_firm": "West-ward Pharmaceutical Corp.",
      "address_1": "465 Industrial Way W",
      "address_2": "N/A",
      "postal_code": "07724-2209",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "All lots were distributed throughout the US.",
      "recall_number": "D-1438-2012",
      "product_description": "Fosphenytoin Sodium Injection, USP, 500 mg PE per 10 mL (50 mg PE per mL), 10 mL Single Dose Vial, packaged in 10-count x 10 mL Single Dose Vials per carton, Rx only, Mfd. By: Hikma Farmaceutica (Portugal), S.A.; Dist. By: West-Ward Pharmaceutical Corp., Eatontown, NJ  07724 USA under the labels a) NOVAPLUS (NDC 0143-9703-10), b) West-Ward (NDC 0143-9782-10).",
      "product_quantity": "a) 74,960 vials; b) 911,070 vials",
      "reason_for_recall": "Presence of Particulate Matter: This product is being recalled due to the discovery of particles in the stability samples and retain samples.",
      "recall_initiation_date": "20120413",
      "center_classification_date": "20120802",
      "termination_date": "20150116",
      "report_date": "20120808",
      "code_info": "Lot #s: a) 112161.1, 112162.1, 112163.1, Exp 05/13; b) 102165.2, 102167.1, Exp 05/12; 102190.1, 102191.1, 102191.2, 102192.1, 102213.1, Exp 07/12; 102240.1, 102241.1, 10227.1, 102272.1, 102272.2, 102273.1, 102274.1, 102275.1, Exp 09/12; 102319.1, 102320.1, 102321.1, 102322.1, 102323.1, 102324.1, 102325.1, Exp 11/12; 102342.1, 102343.1, 102344.1, 102345.1, Exp 12/12; 112019.1, 112020.1, 112021.1, 112022.1, 112023.1, Exp 01/13; 112156.1, 112157.1, 112158.1, 112159.1, 112160.1, Exp 05/13; 112164.1, Exp 06/13; 112203.1, 112204.1, 112205.1, 112206.1, Exp 07/13; 112262.1, 112263.1, Exp 09/13; 112301.1, 112302.1, 112303.1, 112304.1, Exp 10/13; 112323.1, 112324.1, 112325.1, Exp 11/13"
    }
  ]
}