{
  "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": "2026-07-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Parsippany",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA213803"
        ],
        "brand_name": [
          "SUNITINIB MALATE"
        ],
        "generic_name": [
          "SUNITINIB MALATE"
        ],
        "manufacturer_name": [
          "Teva Pharmaceuticals USA, Inc."
        ],
        "product_ndc": [
          "0093-8199",
          "0093-8224",
          "0093-8229",
          "0093-8231"
        ],
        "product_type": [
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        ],
        "route": [
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        ],
        "substance_name": [
          "SUNITINIB MALATE"
        ],
        "rxcui": [
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          "616285",
          "616289",
          "1541890"
        ],
        "spl_id": [
          "20ff6da6-32c4-421d-b7b0-604a502bfcb5"
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        "spl_set_id": [
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        ],
        "package_ndc": [
          "0093-8199-28",
          "0093-8224-28",
          "0093-8229-28",
          "0093-8231-28"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "LVX8N1UT73"
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      },
      "product_type": "Drugs",
      "event_id": "92636",
      "recalling_firm": "Teva Pharmaceuticals USA Inc",
      "address_1": "400 Interpace Pkwy Bldg A",
      "address_2": "N/A",
      "postal_code": "07054-1120",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Product was distributed to 3 wholesalers/distributors who further distributed the product Nationwide in the USA.",
      "recall_number": "D-0913-2023",
      "product_description": "Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx only, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ  07054, NDC 0093-8199-28",
      "product_quantity": "180 bottles",
      "reason_for_recall": "Failed Moisture Limits: Water (moisture) content above the approved product specifications.",
      "recall_initiation_date": "20230705",
      "center_classification_date": "20230711",
      "termination_date": "20240110",
      "report_date": "20230719",
      "code_info": "Lot # 100037220, Exp 10/2024",
      "more_code_info": ""
    }
  ]
}