{
  "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": "Ongoing",
      "city": "New York",
      "state": "NY",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA074086"
        ],
        "brand_name": [
          "DOBUTAMINE"
        ],
        "generic_name": [
          "DOBUTAMINE"
        ],
        "manufacturer_name": [
          "Hospira, Inc."
        ],
        "product_ndc": [
          "0409-2344"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "DOBUTAMINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1812168"
        ],
        "spl_id": [
          "e71e9520-871b-479d-9652-1857fceca863"
        ],
        "spl_set_id": [
          "dc537761-d5f4-488d-24ab-b2bcd2b17b7a"
        ],
        "package_ndc": [
          "0409-2344-01",
          "0409-2344-62",
          "0409-2344-02"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "0WR771DJXV"
        ]
      },
      "product_type": "Drugs",
      "event_id": "96947",
      "recalling_firm": "Pfizer Inc.",
      "address_1": "235 East 42nd Street",
      "address_2": "",
      "postal_code": "10017-5703",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0489-2025",
      "product_description": "DOBUTamine Injection, USP, 250 mg/20 mL (12.5 mg/mL), 20 mL per Single-dose Vial, carton of 10 Fliptop Vials, Rx only, For Intravenous Use Only, Made in Italy, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA.  NDC Carton:  0409-2344-02; NDC Vial: 0409-2344-62",
      "product_quantity": "98,410 vials",
      "reason_for_recall": "Discoloration; discolored solution from cracked vials",
      "recall_initiation_date": "20250528",
      "center_classification_date": "20250623",
      "report_date": "20250702",
      "code_info": "Lot KA5023, exp 02/28/2026",
      "more_code_info": ""
    }
  ]
}