{
  "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": "Lake Zurich",
      "state": "IL",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA077574"
        ],
        "brand_name": [
          "PACLITAXEL"
        ],
        "generic_name": [
          "PACLITAXEL"
        ],
        "manufacturer_name": [
          "Fresenius Kabi USA, LLC"
        ],
        "product_ndc": [
          "63323-763"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "PACLITAXEL"
        ],
        "rxcui": [
          "312199"
        ],
        "spl_id": [
          "11fa3178-16bd-4da3-b276-079ce8e12efb"
        ],
        "spl_set_id": [
          "a6c24189-293f-42ca-b969-75870bb55af0"
        ],
        "package_ndc": [
          "63323-763-05",
          "63323-763-16",
          "63323-763-50"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0363323763503",
          "0363323763169"
        ],
        "nui": [
          "N0000175085",
          "N0000175592"
        ],
        "pharm_class_pe": [
          "Microtubule Inhibition [PE]"
        ],
        "pharm_class_epc": [
          "Microtubule Inhibitor [EPC]"
        ],
        "unii": [
          "P88XT4IS4D"
        ]
      },
      "product_type": "Drugs",
      "event_id": "66810",
      "recalling_firm": "Fresenius Kabi USA, LLC",
      "address_1": "3 Corporate Dr",
      "address_2": "N/A",
      "postal_code": "60047-8930",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US: Nationwide and  Puerto Rico",
      "recall_number": "D-016-2014",
      "product_description": "PACLITAXEL INJECTION, USP (semisynthetic); 300 mg/50 mL; (6 mg/mL); Multiple Dose Vial;(NDC 63323-763-50);  Rx Only; Manufactured for  APP Pharmaceuticals, LLC; Schaumburg, IL 60173; Made in India",
      "product_quantity": "71,129 vials",
      "reason_for_recall": "Labeling: Incorrect or Missing Package Insert- Missing text on the product insert in the \"Clinical Studies\" and \"Specific Adverse Events\" sections.",
      "recall_initiation_date": "20131108",
      "center_classification_date": "20131122",
      "termination_date": "20150512",
      "report_date": "20131204",
      "code_info": "Lot #  871ZA00201, Exp 11/13   Lot #  871ZA00301, Exp 11/13  Lot #  871ZA00302, Exp 11/13  Lot #  871ZA00401, Exp 11/13  Lot #  871ZA00402, Exp 11/13  Lot #  872ZA00101, Exp 12/13  Lot #  872ZA00201, Exp 12/13  Lot #  872ZA00301, Exp 12/13  Lot #  872ZA00401, Exp 12/13  Lot #  872ZA00501, Exp 12/13"
    }
  ]
}