{
  "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 II",
      "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",
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          "0409-1587-50",
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          "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",
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          "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": "75156",
      "recalling_firm": "Hospira Inc., A Pfizer Company",
      "address_1": "275 N Field Dr",
      "address_2": "N/A",
      "postal_code": "60045-2579",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide and Puerto Rico",
      "recall_number": "D-0096-2017",
      "product_description": "Marcaine 0.25% (bupivacaine HCl) injection, USP, 125 mg/50 mL (2.5 mg/mL), 50 mL Multiple-Dose Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1587-50.",
      "product_quantity": "15 vials",
      "reason_for_recall": "Lack of Assurance of Sterility and Subpotent Drug: defect in glass vial prevented stopper from forming a seal allowing water to ingress and dilute the product causing it to be less than the labeled potency.",
      "recall_initiation_date": "20160916",
      "center_classification_date": "20161013",
      "termination_date": "20190731",
      "report_date": "20161019",
      "code_info": "Lot #: 60295DD,  Ep 1DEC2017"
    }
  ]
}