{
  "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": "2026-04-01",
    "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": [
          "30Q7KI53AK",
          "7TQO7W3VT8"
        ]
      },
      "product_type": "Drugs",
      "event_id": "73935",
      "recalling_firm": "Fresenius Kabi USA, LLC",
      "address_1": "3 Corporate Dr",
      "address_2": "",
      "postal_code": "60047-8930",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-1037-2016",
      "product_description": "Sensorcaine- MPF (Bupivacaine HCI Injection, USP), 0.75% in a 30 mL Single Dose Vial, Rx only, Fresenius Kabi USA LLC, Lake Zurich, IL 60047, NDC 63323-472-37",
      "product_quantity": "69225 units",
      "reason_for_recall": "Presence of Particulate Matter: Glass particulate found in sterile injectable product",
      "recall_initiation_date": "20160425",
      "center_classification_date": "20160616",
      "termination_date": "20161020",
      "report_date": "20160622",
      "code_info": "Lot #: 6111504, Exp 09/2019",
      "more_code_info": ""
    }
  ]
}