{
  "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": "2026-07-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Foster City",
      "state": "CA",
      "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": "65555",
      "recalling_firm": "Gilead Sciences, Inc.",
      "address_1": "333 Lakeside Drive",
      "address_2": "N/A",
      "postal_code": "94404-1147",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Foreign distribution only to France, Italy, Switzerland, Portugal, Denmark,Turkey, Ireland, Norway, Malta, UK, Greece, Belgium, Austria, Germany, India, Hong Kong, Israel, Saudi Arabia, Thailand, UAE, Singapore, Ecuador, Oman, El Salvador, MCF Holland, MSF, France, Ethiopia, Egypt, Argentina, Chile, Brazil, Spain, Finland, Sweden.",
      "recall_number": "D-821-2013",
      "product_description": "AmBisome (amphotericin B) liposome for Injection, 50 mg, For Intravenous Infusion Only, Single-Use Vial, 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": "478,352 vials",
      "reason_for_recall": "Lack of Sterility Assurance; During a routine simulation of the manufacturing of AmBisome, a bacterial contamination was detected in some media fill units. No contaminated batches have actually been identified in the finished product, but there is a possibility of contamination.",
      "recall_initiation_date": "20130620",
      "center_classification_date": "20130725",
      "termination_date": "20140305",
      "report_date": "20130731",
      "code_info": "Lot #: 042262AD, 042262AD1, 042263AD, 042263AD1, 042264AD, 042265AD, 042265AD1, 042265AD2, Exp 06/2015; 42269AK, 042270AD, 042270AD1, 042270AD3, 042270AD4, 042273AD, Exp 07/2015 and 07/2016 (Germany only); 042285AD, Exp 08/2015 and 8/2016 (UK only); 042293AA, 042293AE,   042293AK, 042298AD, Exp 09/2015; 0422A6AD, Exp 10/15 (for Finland,  Greece, Turkey) and Exp10/2016 (for Sweden, UK, Lebanon), 0422B0AD, Exp 10/2015 (for Turkey, Netherland, France), and Exp 10/2016 (for Poland),   0422B0AD1, Exp 10/2015, 0422C1AA, 042304AD, Exp 01/2016 (Spain), and Exp 01/2017 (for Germany, Switzerland), 042304AD1, 042311AD, Exp 01/2016,   and Exp 01/2017 (France, UK).",
      "more_code_info": ""
    }
  ]
}