{
  "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": "Horsham",
      "state": "PA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA091649"
        ],
        "brand_name": [
          "CAPECITABINE"
        ],
        "generic_name": [
          "CAPECITABINE"
        ],
        "manufacturer_name": [
          "Teva Pharmaceuticals USA, Inc."
        ],
        "product_ndc": [
          "0093-7473",
          "0093-7474"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "CAPECITABINE"
        ],
        "rxcui": [
          "200327",
          "200328"
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        "spl_id": [
          "94cd2146-70ff-43e3-a896-b9e55d75540f"
        ],
        "spl_set_id": [
          "5753679a-506c-4ac4-b8b2-b27c664d1d40"
        ],
        "package_ndc": [
          "0093-7473-06",
          "0093-7474-89"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000000233",
          "N0000175595"
        ],
        "pharm_class_moa": [
          "Nucleic Acid Synthesis Inhibitors [MoA]"
        ],
        "pharm_class_epc": [
          "Nucleoside Metabolic Inhibitor [EPC]"
        ],
        "unii": [
          "6804DJ8Z9U"
        ]
      },
      "product_type": "Drugs",
      "event_id": "72912",
      "recalling_firm": "Teva North America",
      "address_1": "425 Privet Rd",
      "address_2": "N/A",
      "postal_code": "19044-1220",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-0732-2016",
      "product_description": "Capecitabine tablets USP 500 mg, Cytotoxic Agent, Rx Only, 120 tablets per bottle, Manufactured in Czech Republic by: Teva Czech Industries sro, Czech Republic, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-7474-89",
      "product_quantity": "1,895 bottles",
      "reason_for_recall": "Failed Dissolution Specifications: low test results at the 18 month time-point",
      "recall_initiation_date": "20151221",
      "center_classification_date": "20160301",
      "termination_date": "20170113",
      "report_date": "20160309",
      "code_info": "Lot # 3A404012V, Exp. 4/2016"
    }
  ]
}