{
  "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": "Terminated",
      "city": "Pennington",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA215234"
        ],
        "brand_name": [
          "FULVESTRANT"
        ],
        "generic_name": [
          "FULVESTRANT"
        ],
        "manufacturer_name": [
          "Zydus Pharmaceuticals USA Inc."
        ],
        "product_ndc": [
          "70710-1688"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAMUSCULAR"
        ],
        "substance_name": [
          "FULVESTRANT"
        ],
        "rxcui": [
          "727762"
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        "spl_id": [
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        "spl_set_id": [
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        ],
        "package_ndc": [
          "70710-1688-2",
          "70710-1688-8"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175582",
          "N0000000145",
          "N0000000168"
        ],
        "pharm_class_epc": [
          "Estrogen Receptor Antagonist [EPC]"
        ],
        "pharm_class_moa": [
          "Estrogen Receptor Antagonists [MoA]",
          "Selective Estrogen Receptor Modulators [MoA]"
        ],
        "unii": [
          "22X328QOC4"
        ]
      },
      "product_type": "Drugs",
      "event_id": "90618",
      "recalling_firm": "Zydus Pharmaceuticals (USA) Inc",
      "address_1": "73 Route 31 N",
      "address_2": "",
      "postal_code": "08534-3601",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide.",
      "recall_number": "D-1351-2022",
      "product_description": "Fulvestrant Injection 250mg/5mL (50 mg/mL), Contains 2 Single-Dose Prefilled Syringes, Rx Only, Product of India, Manufactured by: Cadila Healthcare Limited, Ahmadabad, India, Distributed by: Zydus Pharmaceuticals (USA ) Inc.m Pennington, NJ 08534, NDC 70710-1688-8.",
      "product_quantity": "1116 boxes",
      "reason_for_recall": "Failed Impurities/Degradation Specifications",
      "recall_initiation_date": "20220715",
      "center_classification_date": "20220817",
      "termination_date": "20240618",
      "report_date": "20220824",
      "code_info": "Lot # B200076; Exp 31 JAN 2024",
      "more_code_info": ""
    }
  ]
}