{
  "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": "Princeton",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA212514"
        ],
        "brand_name": [
          "AMPHOTERICIN B"
        ],
        "generic_name": [
          "AMPHOTERICIN B"
        ],
        "manufacturer_name": [
          "Sun Pharmaceutical Industries, Inc."
        ],
        "product_ndc": [
          "62756-233"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "AMPHOTERICIN B"
        ],
        "rxcui": [
          "967385"
        ],
        "spl_id": [
          "98d535d7-ba62-47e6-825a-2e7d2d8fc564"
        ],
        "spl_set_id": [
          "593cffa0-c305-48b6-8ec7-331e0ff91d2b"
        ],
        "package_ndc": [
          "62756-233-01",
          "62756-233-02"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0362756233010"
        ],
        "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": "94442",
      "recalling_firm": "SUN PHARMACEUTICAL INDUSTRIES INC",
      "address_1": "2 Independence Way",
      "address_2": "N/A",
      "postal_code": "08540-6620",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide within the United States",
      "recall_number": "D-0493-2024",
      "product_description": "Amphotericin B Liposome for Injection, 50mg vials, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Medicare Limited, Baska Ujeti Road, Ujeti Halol-389350, Gujarat, India. NDC 62756-233-01",
      "product_quantity": "11,016 vials",
      "reason_for_recall": "Out of specification for assay",
      "recall_initiation_date": "20240419",
      "center_classification_date": "20240508",
      "report_date": "20240515",
      "code_info": "Lot #: BAE0055A, BAE0056A, BAE0068A, Exp. Date 03/2026"
    }
  ]
}