{
  "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": "Wilmington",
      "state": "MA",
      "country": "United States",
      "classification": "Class I",
      "openfda": {
        "application_number": [
          "NDA208910"
        ],
        "brand_name": [
          "FIRVANQ"
        ],
        "generic_name": [
          "VANCOMYCIN HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Azurity Pharmaceuticals, Inc"
        ],
        "product_ndc": [
          "65628-204",
          "65628-205",
          "65628-206",
          "65628-208"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "rxcui": [
          "2000127",
          "2000133",
          "2000134",
          "2000136"
        ],
        "spl_id": [
          "5693e540-a3bf-f5fe-e063-6394a90ab1cc"
        ],
        "spl_set_id": [
          "5aca5508-b577-446c-9980-ab4c7582b4b9"
        ],
        "package_ndc": [
          "65628-204-05",
          "65628-205-10",
          "65628-206-05",
          "65628-208-10"
        ],
        "is_original_packager": [
          true
        ]
      },
      "product_type": "Drugs",
      "event_id": "88547",
      "recalling_firm": "Azurity Pharmaceuticals, Inc.",
      "address_1": "841 Woburn St",
      "address_2": "",
      "postal_code": "01887-3414",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "USA nationwide",
      "recall_number": "D-0003-2022",
      "product_description": "Firvanq (vancomycin hydrochloride for oral solution), Vancomycin 50 mg/mL Kit, Each Kit Includes: 1 bottle containing 7.7 g Vancomycin Hydrochloride USP, powder for oral solution and 1 bottle containing 145 mL Grape Flavored Diluent for reconstitution per carton, Rx only, Manufactured for: Azurity pharmaceuticals, Wilmington, MA  01887, NDC 65628-206-05.",
      "product_quantity": "2,751 kits",
      "reason_for_recall": "Product Mix-up: Incorrect diluent component included in the kit.",
      "recall_initiation_date": "20210824",
      "center_classification_date": "20211005",
      "termination_date": "20220512",
      "report_date": "20211013",
      "code_info": "Lot # 21035, Exp 7/31/2022",
      "more_code_info": ""
    }
  ]
}