{
  "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 Forest",
      "state": "IL",
      "country": "United States",
      "classification": "Class I",
      "openfda": {
        "application_number": [
          "NDA016964"
        ],
        "brand_name": [
          "MARCAINE"
        ],
        "generic_name": [
          "BUPIVACAINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Hospira, Inc."
        ],
        "product_ndc": [
          "0409-0525",
          "0409-1559",
          "0409-1560",
          "0409-1582",
          "0409-1587",
          "0409-1610",
          "0409-1746",
          "0409-1749",
          "0409-1752",
          "0409-1755",
          "0409-2510",
          "0409-7535",
          "0409-1250",
          "0409-5010",
          "0409-1530",
          "0409-7510",
          "0409-2253"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "PERINEURAL"
        ],
        "substance_name": [
          "BUPIVACAINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1012377",
          "1012381",
          "1012384",
          "1012388",
          "1012396",
          "1012400",
          "1012404",
          "1012406",
          "1672917",
          "1672919",
          "1673242",
          "1673243",
          "1724786",
          "1724787",
          "1724794",
          "1724796",
          "1724880",
          "1724884",
          "1725044",
          "1725046",
          "1725078",
          "1725079",
          "1725082",
          "1725083",
          "1867594",
          "1867596",
          "1867612",
          "1867614"
        ],
        "spl_id": [
          "b00b78c3-c70d-49b9-a381-6a1496f74153"
        ],
        "spl_set_id": [
          "67578b56-7540-487e-1fba-481255620e78"
        ],
        "package_ndc": [
          "0409-1559-18",
          "0409-1559-10",
          "0409-1559-19",
          "0409-1559-30",
          "0409-1560-18",
          "0409-1560-10",
          "0409-1560-19",
          "0409-1560-29",
          "0409-1582-18",
          "0409-1582-10",
          "0409-1582-19",
          "0409-1582-29",
          "0409-1587-50",
          "0409-1610-50",
          "0409-1746-70",
          "0409-1746-10",
          "0409-1746-71",
          "0409-1746-30",
          "0409-1749-70",
          "0409-1749-10",
          "0409-1749-71",
          "0409-1749-29",
          "0409-1752-50",
          "0409-1755-50",
          "0409-2510-01",
          "0409-2510-25",
          "0409-7535-01",
          "0409-7535-25",
          "0409-1250-01",
          "0409-1250-25",
          "0409-5010-01",
          "0409-5010-25",
          "0409-1530-01",
          "0409-1530-25",
          "0409-0525-01",
          "0409-0525-25",
          "0409-7510-01",
          "0409-7510-25",
          "0409-2253-01",
          "0409-2253-25"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "30Q7KI53AK",
          "7TQO7W3VT8"
        ]
      },
      "product_type": "Drugs",
      "event_id": "68048",
      "recalling_firm": "Hospira Inc.",
      "address_1": "275 N Field Dr",
      "address_2": "",
      "postal_code": "60045-2579",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Press Release",
      "distribution_pattern": "Nationwide.",
      "recall_number": "D-1358-2014",
      "product_description": "Marcaine (bupivacaine HCl) injection, USP, 0.25%, Preservative-Free, 10 mL (25 mg) Single-dose Vial, Rx only, Hospira, Inc., Lake Forest, IL  60045 USP, NDC 0409-1559-10.",
      "product_quantity": "85,680 vials",
      "reason_for_recall": "Presence of Particulate Matter: Confirmed customer complaint of discolored solution with visible metal particles embedded in the glass vial and visible in the solution.",
      "recall_initiation_date": "20140421",
      "center_classification_date": "20140605",
      "termination_date": "20170316",
      "report_date": "20140611",
      "code_info": "Lot #: 34-440-DD, Exp 10/15",
      "more_code_info": ""
    }
  ]
}