{
  "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": "Melrose Park",
      "state": "IL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA075826"
        ],
        "brand_name": [
          "PROPRANOLOL"
        ],
        "generic_name": [
          "PROPRANOLOL HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Fresenius Kabi USA, LLC"
        ],
        "product_ndc": [
          "63323-604"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "PROPRANOLOL HYDROCHLORIDE"
        ],
        "rxcui": [
          "856443"
        ],
        "spl_id": [
          "505851c4-b18c-4cd7-805c-4e923cc1fa7e"
        ],
        "spl_set_id": [
          "f14ea537-dd5c-4c78-9037-9a85e9e610ef"
        ],
        "package_ndc": [
          "63323-604-01"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0363323604004"
        ],
        "unii": [
          "F8A3652H1V"
        ]
      },
      "product_type": "Drugs",
      "event_id": "68910",
      "recalling_firm": "Fresenius Kabi USA, LLC",
      "address_1": "2045 Cornell Ave",
      "address_2": "",
      "postal_code": "60160-1002",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide and Puerto Rico",
      "recall_number": "D-1545-2014",
      "product_description": "PROPRANOLOL HYDROCHLORIDE INJECTION, USP 1 mg/mL, 1 mL Single Dose Vial, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 60173, NDC 63323-604-01",
      "product_quantity": "56,060 vials",
      "reason_for_recall": "CGMP Deviations: Citations given to API supplier by the Italian Health Agency AIFA for several critical deficiencies which caused a recall of the API lot used to manufacture Propanolo HCl Injection.",
      "recall_initiation_date": "20140813",
      "center_classification_date": "20140819",
      "termination_date": "20160524",
      "report_date": "20140827",
      "code_info": "Lot 6007698, Exp. 03/16",
      "more_code_info": ""
    }
  ]
}