{
  "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": "Northbrook",
      "state": "IL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "NDA050740"
        ],
        "brand_name": [
          "AMBISOME"
        ],
        "generic_name": [
          "AMPHOTERICIN B"
        ],
        "manufacturer_name": [
          "Astellas Pharma US, Inc."
        ],
        "product_ndc": [
          "0469-3051"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "AMPHOTERICIN B"
        ],
        "rxcui": [
          "967385",
          "967388"
        ],
        "spl_id": [
          "1369d969-91c2-42dc-b8c5-27e8703a2b68"
        ],
        "spl_set_id": [
          "f7be6506-4d20-401e-a0ff-02ad7c33158a"
        ],
        "package_ndc": [
          "0469-3051-30"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175510",
          "N0000175498",
          "M0017172"
        ],
        "pharm_class_epc": [
          "Lipid-based Polyene Antifungal [EPC]",
          "Polyene Antifungal [EPC]"
        ],
        "pharm_class_cs": [
          "Polyenes [CS]"
        ],
        "unii": [
          "7XU7A7DROE"
        ]
      },
      "product_type": "Drugs",
      "event_id": "65496",
      "recalling_firm": "Astellas Pharma US Inc",
      "address_1": "1 Astellas Way",
      "address_2": "N/A",
      "postal_code": "60062-6111",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide and Canada",
      "recall_number": "D-820-2013",
      "product_description": "AmBisome (amphotericin B) liposome for injection, 50mg vial, single use vial, For Intravenous Infusion Only, Rx Only, Marketed by: Astellas Pharma US, Inc., Northbrook, IL 60062, Manufactured by: Gilead Sciences, Inc, San Dimas, CA 91773, NDC: 0469-3051-30.",
      "product_quantity": "133,550 Vials",
      "reason_for_recall": "Lack of Assurance of Sterility; Astellas Pharma US, Inc. is performing a voluntary recall on certain lots of AmBisome because the manufacturer has notified Astellas that during a routine simulation of the manufacturing of AmBisome, a bacterial contamination was detected in the media fills.",
      "recall_initiation_date": "20130619",
      "center_classification_date": "20130725",
      "termination_date": "20140204",
      "report_date": "20130731",
      "code_info": "Lot #: 042267AA, Exp July 2015, 042287AA, 042289AA, 042291AA, Exp Aug 2015.    Lot Numbers and Expiry Dates (for Canada distribution).  LOT 042269AA, EXP 07/2015,  LOT 0422C1AA, EXP 11/2015.",
      "more_code_info": ""
    }
  ]
}