{
  "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": "Princeton",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA061395"
        ],
        "brand_name": [
          "AMPICILLIN"
        ],
        "generic_name": [
          "AMPICILLIN SODIUM"
        ],
        "manufacturer_name": [
          "Sandoz Inc"
        ],
        "product_ndc": [
          "0781-3400",
          "0781-3402",
          "0781-3407",
          "0781-3404",
          "0781-3408"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAMUSCULAR",
          "INTRAVENOUS"
        ],
        "substance_name": [
          "AMPICILLIN SODIUM"
        ],
        "rxcui": [
          "308207",
          "1721473",
          "1721474",
          "1721475",
          "1721476"
        ],
        "spl_id": [
          "2cc1b620-59dd-4d45-8edf-af20bdd82ee5"
        ],
        "spl_set_id": [
          "64a04e8c-8f78-46b3-8f45-56ef225a4f74"
        ],
        "package_ndc": [
          "0781-3400-78",
          "0781-3400-95",
          "0781-3402-78",
          "0781-3402-95",
          "0781-3407-78",
          "0781-3407-95",
          "0781-3404-85",
          "0781-3404-95",
          "0781-3408-80",
          "0781-3408-95"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "JFN36L5S8K"
        ]
      },
      "product_type": "Drugs",
      "event_id": "78169",
      "recalling_firm": "Sandoz Inc",
      "address_1": "100 College Rd W",
      "address_2": "N/A",
      "postal_code": "08540-6604",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA and Puerto Rico",
      "recall_number": "D-1179-2017",
      "product_description": "Ampicillin for Injection, USP, 500 mg per vial, single vial (NDC 0781-3407-78) packaged in 10-count shrink wrap packs (NDC 0781-3407-95), Rx only, Manufactured in Austria by Sandoz GmbH or Sandoz Inc., Princeton, NJ  08540.",
      "product_quantity": "13,435 shrink wrap packs",
      "reason_for_recall": "Labeling: Missing Label: customer complaint that some vials of ampicillin within the shrink wrap pack are missing labels.",
      "recall_initiation_date": "20170925",
      "center_classification_date": "20170928",
      "termination_date": "20190408",
      "report_date": "20171004",
      "code_info": "Lot: GH8254, Exp 06/19"
    }
  ]
}