{
  "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": "2026-07-22",
    "results": {
      "skip": 0,
      "limit": 1,
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    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Pulaski",
      "state": "TN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
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        ],
        "brand_name": [
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        ],
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        "manufacturer_name": [
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          "42291-902",
          "42291-903",
          "42291-904"
        ],
        "product_type": [
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        "route": [
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        "substance_name": [
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        "rxcui": [
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          "616285",
          "616289",
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          "42291-902-28",
          "42291-903-28",
          "42291-904-28"
        ],
        "original_packager_product_ndc": [
          "0093-8199",
          "0093-8224",
          "0093-8229",
          "0093-8231"
        ],
        "unii": [
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      },
      "product_type": "Drugs",
      "event_id": "95596",
      "recalling_firm": "AvKARE",
      "address_1": "615 N 1st St",
      "address_2": "",
      "postal_code": "38478-2403",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide within the United States",
      "recall_number": "D-0104-2025",
      "product_description": "Sunitinib Malate Capsules, 25 mg, 28-count bottles, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478.  NDC 42291-902-28",
      "product_quantity": "20 bottles",
      "reason_for_recall": "Labeling: Label Mix-Up",
      "recall_initiation_date": "20241018",
      "center_classification_date": "20241204",
      "report_date": "20241211",
      "code_info": "Lot #: 100049501, Exp. Date 07/31/2026",
      "more_code_info": ""
    }
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}