{
  "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 Forest",
      "state": "IL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA062420"
        ],
        "brand_name": [
          "GENTAMICIN SULFATE"
        ],
        "generic_name": [
          "GENTAMICIN SULFATE"
        ],
        "manufacturer_name": [
          "Hospira, Inc."
        ],
        "product_ndc": [
          "0409-1207"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAMUSCULAR",
          "INTRAVENOUS"
        ],
        "substance_name": [
          "GENTAMICIN SULFATE"
        ],
        "rxcui": [
          "1870650"
        ],
        "spl_id": [
          "90119984-4be7-494f-9ba0-61ec49c15143"
        ],
        "spl_set_id": [
          "977180b3-a222-4282-d485-4a3217674305"
        ],
        "package_ndc": [
          "0409-1207-13",
          "0409-1207-03"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "8X7386QRLV"
        ]
      },
      "product_type": "Drugs",
      "event_id": "65226",
      "recalling_firm": "Hospira Inc.",
      "address_1": "275 N Field Dr",
      "address_2": "N/A",
      "postal_code": "60045-2579",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-686-2013",
      "product_description": "Gentamicin Sulfate Injection USP 80 mg/2 mL(40 mg/mL as Gentamicin), 2 mL Single-dose Fliptop Vial, (NDC 0409-1207-13), Rx only, Manufactured by Hospira, Inc, Lake Forest, IL 60046 USA.",
      "product_quantity": "168,300 vals",
      "reason_for_recall": "Presence of Particulate Matter: visible particles were identified floating in the primary container.",
      "recall_initiation_date": "20130502",
      "center_classification_date": "20130708",
      "termination_date": "20141028",
      "report_date": "20130717",
      "code_info": "Lot 07-067-DK Exp. 07/13"
    }
  ]
}