{
  "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,
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    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Jacksonville",
      "address_1": "4345 Southpoint Blvd",
      "reason_for_recall": "Temperature Abuse: One shipment was inadvertantly stored refrigerated rather than the labeled room temperature recommendation at McKesson Medical-Surgical Inc., one of the distributing wholesalers.",
      "address_2": "",
      "product_quantity": "10 vials",
      "code_info": "Lot #140502, Exp 10/31/2015",
      "center_classification_date": "20141003",
      "distribution_pattern": "McKesson Medical-Surgical Inc distributed to (6) physicians and/or medical facilities in WA, OR, and MT.",
      "state": "FL",
      "product_description": "Amiodarone HCl Injection, 450 mg/9 mL (50 mg per mL), 9 mL Single-Use Vial, Rx only, Manufactured for Mylan Institutional, LLC, Rockford, IL 61103, NDC 67457-153-09.",
      "report_date": "20141015",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA076217"
        ],
        "brand_name": [
          "AMIODARONE HYDROCHLORIDE"
        ],
        "generic_name": [
          "AMIODARONE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Mylan Institutional LLC"
        ],
        "product_ndc": [
          "67457-153"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "AMIODARONE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1663224",
          "1663244",
          "1663248"
        ],
        "spl_id": [
          "bd9c578c-322f-41fc-936d-bf9b551a2782"
        ],
        "spl_set_id": [
          "fcc8658c-761a-443f-8c32-1499d86028ec"
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        "package_ndc": [
          "67457-153-00",
          "67457-153-03",
          "67457-153-99",
          "67457-153-09",
          "67457-153-18"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "976728SY6Z"
        ]
      },
      "recalling_firm": "Mckesson",
      "recall_number": "D-0005-2015",
      "initial_firm_notification": "Telephone",
      "product_type": "Drugs",
      "event_id": "69346",
      "termination_date": "20170417",
      "more_code_info": "",
      "recall_initiation_date": "20140912",
      "postal_code": "32216-6166",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}