{
  "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": "2026-07-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Lake Zurich",
      "state": "IL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "NDA020533"
        ],
        "brand_name": [
          "NAROPIN"
        ],
        "generic_name": [
          "ROPIVACAINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Fresenius Kabi USA, LLC"
        ],
        "product_ndc": [
          "63323-285",
          "63323-286",
          "63323-287",
          "63323-288"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "EPIDURAL",
          "INFILTRATION"
        ],
        "substance_name": [
          "ROPIVACAINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "905189",
          "905191",
          "1734084",
          "1734086",
          "1734090",
          "1734091",
          "1734203",
          "1734204",
          "1734207",
          "1734208",
          "1734347",
          "1734348",
          "1734355",
          "1734356",
          "1734475",
          "1734476",
          "1734479",
          "1734480",
          "1734481",
          "1734482",
          "1734483",
          "1734484"
        ],
        "spl_id": [
          "cdcd6c58-85cf-4d7e-9d97-b7c282a4f6b9"
        ],
        "spl_set_id": [
          "23d2d448-a744-4877-9f2d-7e57c198da89"
        ],
        "package_ndc": [
          "63323-286-01",
          "63323-286-20",
          "63323-286-05",
          "63323-286-23",
          "63323-286-09",
          "63323-286-31",
          "63323-286-11",
          "63323-286-35",
          "63323-286-03",
          "63323-286-00",
          "63323-286-33",
          "63323-286-63",
          "63323-286-30",
          "63323-287-01",
          "63323-287-20",
          "63323-287-03",
          "63323-287-21",
          "63323-288-01",
          "63323-288-10",
          "63323-288-06",
          "63323-288-20",
          "63323-288-03",
          "63323-288-11",
          "63323-288-07",
          "63323-288-21",
          "63323-285-01",
          "63323-285-10",
          "63323-285-06",
          "63323-285-20",
          "63323-285-03",
          "63323-285-13",
          "63323-285-07",
          "63323-285-23",
          "63323-285-57",
          "63323-285-64",
          "63323-285-51",
          "63323-285-65",
          "63323-285-02",
          "63323-285-61",
          "63323-285-04",
          "63323-285-63"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0363323286033",
          "0363323285074",
          "0363323285036",
          "0363323285579",
          "0363323287030",
          "0363323286095",
          "0363323288075",
          "0363323286330",
          "0363323286057",
          "0363323288037",
          "0363323286118",
          "0363323285517"
        ],
        "unii": [
          "V910P86109"
        ]
      },
      "product_type": "Drugs",
      "event_id": "99449",
      "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 within in the USA",
      "recall_number": "D-0727-2026",
      "product_description": "Naropin (ropivacaine hydrochloride Injection, USP), 0.5%, 100 mg per 20 mL (5 mg per mL), Twenty-five, 20 mL Single-Dose Vials, Rx only, Fresenius Kabi, Lake Zurich, IL 60047 NDC Tray: 63323-286-23; NDC Vial:  63323-286-05",
      "product_quantity": "92,600 vials",
      "reason_for_recall": "Presence of Particulate Matter: Hair was found in products",
      "recall_initiation_date": "20260716",
      "center_classification_date": "20260723",
      "report_date": "20260729",
      "code_info": "Lot #: 6133436, Exp. Date 10/2028"
    }
  ]
}