{
  "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": "New York",
      "state": "NY",
      "country": "United States",
      "classification": "Class I",
      "openfda": {
        "application_number": [
          "ANDA062912"
        ],
        "brand_name": [
          "VANCOMYCIN HYDROCHLORIDE"
        ],
        "generic_name": [
          "VANCOMYCIN HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Hospira, Inc."
        ],
        "product_ndc": [
          "0409-3515",
          "0409-6531",
          "0409-6533",
          "0409-4332"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "VANCOMYCIN HYDROCHLORIDE"
        ],
        "rxcui": [
          "1807513",
          "1807516",
          "1807518",
          "2049890"
        ],
        "spl_id": [
          "10032a19-0373-4c42-b785-f3d915614e30"
        ],
        "spl_set_id": [
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        ],
        "package_ndc": [
          "0409-6531-12",
          "0409-6531-02",
          "0409-6533-11",
          "0409-6533-01",
          "0409-6533-21",
          "0409-4332-11",
          "0409-4332-01",
          "0409-3515-11",
          "0409-3515-01"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "71WO621TJD"
        ]
      },
      "product_type": "Drugs",
      "event_id": "91346",
      "recalling_firm": "Pfizer Inc.",
      "address_1": "235 East 42nd Street",
      "address_2": "N/A",
      "postal_code": "10017-5703",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Press Release",
      "distribution_pattern": "USA nationwide and Puerto Rico",
      "recall_number": "D-0184-2023",
      "product_description": "Vancomycin Hydrochloride for Injection, USP, 1.5 g/vial, Sterile powder, Single-dose Fliptop Vial,  10 vials per carton, Rx only, Distributed by: Hospira, Inc., Lake Forest, IL 60045.  NDC Vial 0409-3515-11; NDC Carton 0409-3515-01",
      "product_quantity": "89,700 vials",
      "reason_for_recall": "Presence of Particulate Matter: Glass particulate matter detected in injectable.",
      "recall_initiation_date": "20221222",
      "center_classification_date": "20230125",
      "termination_date": "20240807",
      "report_date": "20230201",
      "code_info": "Lot: 33045BA, EXP 1SEP2023",
      "more_code_info": ""
    }
  ]
}