{
  "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": "Ongoing",
      "city": "Princeton",
      "state": "NJ",
      "country": "United States",
      "classification": "Class I",
      "openfda": {
        "application_number": [
          "ANDA065079"
        ],
        "brand_name": [
          "PENICILLIN G POTASSIUM"
        ],
        "generic_name": [
          "PENICILLIN G POTASSIUM"
        ],
        "manufacturer_name": [
          "Sandoz Inc"
        ],
        "product_ndc": [
          "0781-6135",
          "0781-6136"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAMUSCULAR",
          "INTRAVENOUS"
        ],
        "substance_name": [
          "PENICILLIN G POTASSIUM"
        ],
        "rxcui": [
          "863538"
        ],
        "spl_id": [
          "e76e56d8-13b5-4520-8aa3-9202ceef1a03"
        ],
        "spl_set_id": [
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        ],
        "package_ndc": [
          "0781-6135-94",
          "0781-6135-95",
          "0781-6136-94"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "VL775ZTH4C"
        ]
      },
      "product_type": "Drugs",
      "event_id": "97140",
      "recalling_firm": "Sandoz Inc",
      "address_1": "100 College Rd W",
      "address_2": "",
      "postal_code": "08540-6604",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Press Release",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0570-2025",
      "product_description": "Buffered Penicillin G Potassium for Injection, USP 20,000,000 Units (20 million units), For IV use, Sterile, Rx Only, Manufactured in Austria by Sandoz GmbH for Sandoz Inc. Princeton, NJ 08540, NDC: 0781-6136-94.",
      "product_quantity": "unknown",
      "reason_for_recall": "Labeling: Label Mix-Up; Some vials of Cefazolin for Injection, USP 1 gram were incorrectly labeled as penicillin G potassium for Injection, USP, 20 million Unit",
      "recall_initiation_date": "20250627",
      "center_classification_date": "20250806",
      "report_date": "20250709",
      "code_info": "Lot # PG4360, PG4362, Exp. 11/30/2027",
      "more_code_info": ""
    }
  ]
}