{
  "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": "Terminated",
      "city": "Lake Zurich",
      "state": "IL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA070967"
        ],
        "brand_name": [
          "SENSORCAINE"
        ],
        "generic_name": [
          "BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE"
        ],
        "manufacturer_name": [
          "Fresenius Kabi USA, LLC"
        ],
        "product_ndc": [
          "63323-461",
          "63323-472",
          "63323-463",
          "63323-468"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INFILTRATION",
          "PERINEURAL"
        ],
        "substance_name": [
          "BUPIVACAINE HYDROCHLORIDE",
          "EPINEPHRINE BITARTRATE"
        ],
        "rxcui": [
          "1012377",
          "1012384",
          "1012413",
          "1012417",
          "1724786",
          "1724787",
          "1724809",
          "1724810",
          "1867594",
          "1867596",
          "1867618",
          "1867620"
        ],
        "spl_id": [
          "cc1f6507-eb3e-4398-a1d3-0c56a2099e6b"
        ],
        "spl_set_id": [
          "bc61a9a6-0a4e-48a9-b908-e5e66b9f23eb"
        ],
        "package_ndc": [
          "63323-472-03",
          "63323-472-17",
          "63323-472-01",
          "63323-472-37",
          "63323-463-01",
          "63323-463-57",
          "63323-461-01",
          "63323-461-57",
          "63323-468-02",
          "63323-468-37",
          "63323-468-01",
          "63323-468-17"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0363323472030",
          "0363323461010",
          "0363323463014",
          "0363323468026",
          "0363323472016",
          "0363323468019"
        ],
        "unii": [
          "7TQO7W3VT8",
          "30Q7KI53AK"
        ]
      },
      "product_type": "Drugs",
      "event_id": "91198",
      "recalling_firm": "Fresenius Kabi USA, LLC",
      "address_1": "3 Corporate Dr",
      "address_2": "N/A",
      "postal_code": "60047-8930",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0127-2023",
      "product_description": "Sensorcaine (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.25%, 125 mg per 50 mL (2.5 mg per mL), 50 mL Multiple Dose Vial (NDC 63323-461-01), packaged in 25 Multiple Dose Vials per tray (NDC 63323-461-57), Rx only, Fresenius Kabi, Lake Zurich, IL 60047.",
      "product_quantity": "40,375 vials",
      "reason_for_recall": "Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.",
      "recall_initiation_date": "20221122",
      "center_classification_date": "20230113",
      "termination_date": "20231023",
      "report_date": "20230125",
      "code_info": "Batch #: 6128061, exp 03/2024; 6128663, 6128664, exp 05/2024"
    }
  ]
}