{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "ISELIN",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA214476"
        ],
        "brand_name": [
          "POSACONAZOLE"
        ],
        "generic_name": [
          "POSACONAZOLE"
        ],
        "manufacturer_name": [
          "Biocon Phama Inc."
        ],
        "product_ndc": [
          "70377-038"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "POSACONAZOLE"
        ],
        "rxcui": [
          "1482908"
        ],
        "spl_id": [
          "b7a2fd29-83b5-6ae6-775c-98f91a6c0ea4"
        ],
        "spl_set_id": [
          "e0e8023a-3c82-e455-a57b-ccc0206ad156"
        ],
        "package_ndc": [
          "70377-038-11"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175487",
          "M0002083"
        ],
        "pharm_class_epc": [
          "Azole Antifungal [EPC]"
        ],
        "pharm_class_cs": [
          "Azoles [CS]"
        ],
        "unii": [
          "6TK1G07BHZ"
        ]
      },
      "product_type": "Drugs",
      "event_id": "91577",
      "recalling_firm": "BIOCON PHARMA INC",
      "address_1": "485 HWY 1 (S)",
      "address_2": "",
      "postal_code": "08830",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0268-2023",
      "product_description": "Posaconazole Delayed-Release Tablets, 100 mg, 60-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ  08830-3009; Manufactured by: Biocon Pharma Limited, Bengaluru, India - 560 099, NDC 70377-038-11.",
      "product_quantity": "3665 bottles",
      "reason_for_recall": "Failed Impurities/Degradation Specifications: High Out Of Specification degradation results.",
      "recall_initiation_date": "20230131",
      "center_classification_date": "20230214",
      "termination_date": "20240621",
      "report_date": "20230215",
      "code_info": "Lot #: BF21003163, BF21003246, BF21003161, Exp. Sep-2023; BF21004742, Exp. Dec-2023; BF22003359, Exp. Sep-2025",
      "more_code_info": ""
    }
  ]
}