{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Hyderabad",
      "state": "N/A",
      "country": "India",
      "classification": "Class I",
      "openfda": {
        "application_number": [
          "ANDA090349"
        ],
        "brand_name": [
          "AMPICILLIN AND SULBACTAM"
        ],
        "generic_name": [
          "AMPICILLIN SODIUM AND SULBACTAM SODIUM"
        ],
        "manufacturer_name": [
          "Eugia US LLC"
        ],
        "product_ndc": [
          "55150-116",
          "55150-117",
          "55150-178",
          "55150-179"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAMUSCULAR",
          "INTRAVENOUS"
        ],
        "substance_name": [
          "AMPICILLIN SODIUM",
          "SULBACTAM SODIUM"
        ],
        "rxcui": [
          "1659592",
          "1659598"
        ],
        "spl_id": [
          "13813cd5-ff90-48a1-97d4-3a0f1db1fb45"
        ],
        "spl_set_id": [
          "adc92303-b62b-41c8-becf-9c3a4e8c3a6b"
        ],
        "package_ndc": [
          "55150-116-20",
          "55150-117-20",
          "55150-178-99",
          "55150-179-99"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0355150116201",
          "0355150179992",
          "0355150178995",
          "0355150117208"
        ],
        "unii": [
          "DKQ4T82YE6",
          "JFN36L5S8K"
        ]
      },
      "product_type": "Drugs",
      "event_id": "78847",
      "recalling_firm": "Aurobindo Pharma Ltd.",
      "address_1": "Unit Xii, Lactam Formulation Plant",
      "address_2": "Survey No. 314, Bachupally, Quthbullapur",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "distributed nationwide in the USA",
      "recall_number": "D-0339-2018",
      "product_description": "Ampicillin and Sulbactam for Injection 1.5 g vial, sterile  Dry Powder for injection, 10 vials per carton, Distributed by AuroMedics Pharma LLC. 279 Princeton-Highstown Rd. E. Windsor, NJ 08520, NDC 55150-116-20",
      "product_quantity": "53,040 vials",
      "reason_for_recall": "Presence of Particulate Matter: A confirmed customer report was received for the presence of visible particulate matter, confirmed as glass, within a single vial.",
      "recall_initiation_date": "20180102",
      "center_classification_date": "20180208",
      "termination_date": "20190910",
      "report_date": "20180214",
      "code_info": "Lot Number AF0117001-A"
    }
  ]
}