{
  "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": "East Windsor",
      "state": "NJ",
      "country": "United States",
      "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": "79996",
      "recalling_firm": "AuroMedics Pharma 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 and Puerto Rico",
      "recall_number": "D-0866-2018",
      "product_description": "Ampicillin and Sulbactam for Injection, USP, 3 gram*s/vial, For Intramuscular or Intravenous Use, Sterile, Manufactured for: AuroMedics Pharma LLC, 6  Wheeling Road, Dayton, NJ, NDC 55150-117-20.",
      "product_quantity": "54,720 vials",
      "reason_for_recall": "Presence of Particulate Matter: confirmed customer report of the presence of visible particulate matter believed to be red rubber particles from the manufacturing process of the active ingredients.",
      "recall_initiation_date": "20180501",
      "center_classification_date": "20180614",
      "termination_date": "20241106",
      "report_date": "20180516",
      "code_info": "Lot #: AS0317041-A, AS0317035-A; Exp August 2019"
    }
  ]
}