{
  "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": "Melrose Park",
      "state": "IL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA062366"
        ],
        "brand_name": [
          "GENTAMICIN"
        ],
        "generic_name": [
          "GENTAMICIN SULFATE"
        ],
        "manufacturer_name": [
          "Fresenius Kabi USA, LLC"
        ],
        "product_ndc": [
          "63323-010"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAMUSCULAR",
          "INTRAVENOUS"
        ],
        "substance_name": [
          "GENTAMICIN SULFATE"
        ],
        "rxcui": [
          "313996"
        ],
        "spl_id": [
          "cf4327d0-9155-4a07-9c54-51592b66b817"
        ],
        "spl_set_id": [
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        ],
        "package_ndc": [
          "63323-010-01",
          "63323-010-02",
          "63323-010-03",
          "63323-010-20"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0363323010034",
          "0363323010010"
        ],
        "unii": [
          "8X7386QRLV"
        ]
      },
      "product_type": "Drugs",
      "event_id": "69810",
      "recalling_firm": "Fresenius Kabi USA, LLC",
      "address_1": "2045 Cornell Ave",
      "address_2": "N/A",
      "postal_code": "60160-1002",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide and Puerto Rico",
      "recall_number": "D-0290-2015",
      "product_description": "GENTAMICIN INJECTION, USP, equivalent to 40 mg/mL, Rx only, 20 mL Multiple Dose Vial, Manufactured by APP Pharmaceuticals, LLC, Schaumburg, IL 60173, NDC 63323-010-20",
      "product_quantity": "92,125 vials",
      "reason_for_recall": "Defective Container: Vials may be missing stoppers.",
      "recall_initiation_date": "20141112",
      "center_classification_date": "20141208",
      "termination_date": "20160308",
      "report_date": "20141217",
      "code_info": "Product Code: 1020;   NDC: 63323-010-20;   Lot Number: 6107992;   Expiration Date: 09/2015"
    }
  ]
}