{
  "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": "East Windsor",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA206918"
        ],
        "brand_name": [
          "FONDAPARINUX SODIUM"
        ],
        "generic_name": [
          "FONDAPARINUX SODIUM"
        ],
        "manufacturer_name": [
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        ],
        "product_ndc": [
          "55150-230",
          "55150-231",
          "55150-232",
          "55150-233"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "SUBCUTANEOUS"
        ],
        "substance_name": [
          "FONDAPARINUX SODIUM"
        ],
        "rxcui": [
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          "861360",
          "861363",
          "861365"
        ],
        "spl_id": [
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        ],
        "spl_set_id": [
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        "package_ndc": [
          "55150-230-00",
          "55150-230-02",
          "55150-230-10",
          "55150-231-00",
          "55150-231-02",
          "55150-231-10",
          "55150-232-00",
          "55150-232-02",
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          "55150-233-00",
          "55150-233-02",
          "55150-233-10"
        ],
        "is_original_packager": [
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        ],
        "unii": [
          "X0Q6N9USOZ"
        ]
      },
      "product_type": "Drugs",
      "event_id": "90925",
      "recalling_firm": "AuroMedics Pharma LLC",
      "address_1": "279 Princeton Hightstown Rd",
      "address_2": "N/A",
      "postal_code": "08520-1401",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0020-2023",
      "product_description": "Fondaparinux Sodium Injection, USP, 7.5 mg per 0.6 mL, Single Dose, Prefilled Syringe, Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520. Made in India. NDC 55150-232-10 (carton)NDC 55150-232-00 (syringe)",
      "product_quantity": "11,520 units",
      "reason_for_recall": "Subpotent Drug: Out of specification for assay",
      "recall_initiation_date": "20220930",
      "center_classification_date": "20221024",
      "termination_date": "20240918",
      "report_date": "20221102",
      "code_info": "Lot # CFN200020, EXP Nov. 2022",
      "more_code_info": ""
    }
  ]
}