{
  "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,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Schaumburg",
      "state": "IL",
      "country": "United States",
      "classification": "Class I",
      "openfda": {
        "application_number": [
          "ANDA213510"
        ],
        "brand_name": [
          "DOCETAXEL"
        ],
        "generic_name": [
          "DOCETAXEL ANHYDROUS"
        ],
        "manufacturer_name": [
          "Sagent Pharmaceuticals"
        ],
        "product_ndc": [
          "25021-254"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "DOCETAXEL ANHYDROUS"
        ],
        "rxcui": [
          "1093280"
        ],
        "spl_id": [
          "841e3024-e160-4c4b-93d3-1e79d628d95b"
        ],
        "spl_set_id": [
          "6b227144-c844-4549-960c-cc3ac5c13b2b"
        ],
        "package_ndc": [
          "25021-254-08",
          "25021-254-16"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175085",
          "N0000175592"
        ],
        "pharm_class_pe": [
          "Microtubule Inhibition [PE]"
        ],
        "pharm_class_epc": [
          "Microtubule Inhibitor [EPC]"
        ],
        "unii": [
          "699121PHCA"
        ]
      },
      "product_type": "Drugs",
      "event_id": "94707",
      "recalling_firm": "Sagent Pharmaceuticals",
      "address_1": "1901 N Roselle Rd Ste 450",
      "address_2": "N/A",
      "postal_code": "60195",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "distribution_pattern": "Nationwide within the USA.",
      "recall_number": "D-0553-2024",
      "product_description": "Docetaxel Injection, USP, 80 mg per 8 mL (10 mg per mL), 1 x 8 mL Multi-Dose Vial, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195 (USA), Made in India. NDC 25021-254-08",
      "product_quantity": "762 vials",
      "reason_for_recall": "Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.",
      "recall_initiation_date": "20240528",
      "center_classification_date": "20240612",
      "report_date": "20240619",
      "code_info": "Lot #: F1040001, Exp. Date 12/31/2024"
    }
  ]
}