{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "East Windsor",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA215236"
        ],
        "brand_name": [
          "GENTAMICIN"
        ],
        "generic_name": [
          "GENTAMICIN"
        ],
        "manufacturer_name": [
          "Eugia US LLC"
        ],
        "product_ndc": [
          "55150-401"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAMUSCULAR",
          "INTRAVENOUS"
        ],
        "substance_name": [
          "GENTAMICIN SULFATE"
        ],
        "rxcui": [
          "1870676"
        ],
        "spl_id": [
          "ec7eac4d-564f-4f16-b90a-a0c54d403056"
        ],
        "spl_set_id": [
          "f8c608b3-50b8-4d5d-9e8a-e92c0d2e3cdc"
        ],
        "package_ndc": [
          "55150-401-01",
          "55150-401-25"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "8X7386QRLV"
        ]
      },
      "product_type": "Drugs",
      "event_id": "96976",
      "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 in the USA",
      "recall_number": "D-0472-2025",
      "product_description": "Gentamicin Injection, USP, (PEDIATRIC), 20 mg per 2 mL (10 mg per mL*), 2 mL Single-Dose Vial, Rx Only, Mfd. in India for: Eugia US LLC, E. Windsor, NJ, 08520 Vial- NDC 55150-401-01, Carton NDC 55150-401-25",
      "product_quantity": "48,000 vials",
      "reason_for_recall": "Failed Stability Specifications:  Out of specification results for the Color Absorbance test during 12 Month sample analysis.",
      "recall_initiation_date": "20250529",
      "center_classification_date": "20250618",
      "report_date": "20250625",
      "code_info": "Batch 3GT23006, 3GT23007, 3GT23008, Exp Date: November, 30, 2025",
      "more_code_info": ""
    }
  ]
}