{
  "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": "Terminated",
      "city": "East Windsor",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA217519"
        ],
        "brand_name": [
          "TOBRAMYCIN"
        ],
        "generic_name": [
          "TOBRAMYCIN"
        ],
        "manufacturer_name": [
          "Eugia US LLC"
        ],
        "product_ndc": [
          "55150-470"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "TOBRAMYCIN SULFATE"
        ],
        "rxcui": [
          "597823"
        ],
        "spl_id": [
          "a4205ba6-2eba-4e4e-a2d4-b54447ed85f1"
        ],
        "spl_set_id": [
          "c37c251f-92e9-40f0-8b0c-00d42875d776"
        ],
        "package_ndc": [
          "55150-470-01",
          "55150-470-06"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0355150470013"
        ],
        "unii": [
          "HJT0RXD7JK"
        ]
      },
      "product_type": "Drugs",
      "event_id": "94081",
      "recalling_firm": "Eugia US 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",
      "recall_number": "D-0385-2024",
      "product_description": "Tobramycin for Injection, USP, 1.2 grams per Pharmacy Bulk Package, Rx Only, For Intravenous Use, PHARMACY BULK PACKAGE NOT FOR DIRECT INFUSION, Mfd. in India for: Eugia US LLC, E. Windsor, NJ 08520, Carton NDC 55150-470-06, Vial NDC 55150-470-01.",
      "product_quantity": "1160 VIALS",
      "reason_for_recall": "Failed Stability Specification: Water determination was found not complying with specification.",
      "recall_initiation_date": "20240222",
      "center_classification_date": "20240314",
      "termination_date": "20251222",
      "report_date": "20240320",
      "code_info": "Lot #s: 3TB23001, 3TB23002, Exp. 04/30/2025."
    }
  ]
}