{
  "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": "2026-07-29",
    "results": {
      "skip": 0,
      "limit": 1,
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    }
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  "results": [
    {
      "status": "Terminated",
      "city": "Mahwah",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
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        ],
        "brand_name": [
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        ],
        "generic_name": [
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        "manufacturer_name": [
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        ],
        "product_ndc": [
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        ],
        "product_type": [
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        ],
        "route": [
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        "substance_name": [
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        "rxcui": [
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        "spl_id": [
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        "spl_set_id": [
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        "package_ndc": [
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          "68462-317-32"
        ],
        "is_original_packager": [
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        "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": "88591",
      "recalling_firm": "Glenmark Pharmaceuticals Inc., USA",
      "address_1": "750 Corporate Dr",
      "address_2": "",
      "postal_code": "07430-2009",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide.",
      "recall_number": "D-0820-2021",
      "product_description": "Fulvestrant Injection 250 mg/5 mL (50 mg/mL) For Intramuscular Use Only Contains 2 single-dose pre-filled syringes Rx only NDC 68462-317-32",
      "product_quantity": "28658 cartons",
      "reason_for_recall": "Lack of Assurance of Sterility",
      "recall_initiation_date": "20210827",
      "center_classification_date": "20210921",
      "termination_date": "20231004",
      "report_date": "20210929",
      "code_info": "Lots: 30200014 Exp. 04/30/2022; 30200015 Exp. 05/31/2022; 30200015 Exp. 05/31/2022; 30200016 Exp. 05/31/2022; 30200036 Exp. 09/30/2022; 30200038 Exp. 09/30/2022; 30200039 Exp. 09/30/2022; 30200040 Exp. 09/30/2022; 30210001 Exp. 12/31/2022; 30210002 Exp. 12/31/2022; 30210003 Exp. 01/31/2023; 30210004 Exp. 01/31/2023; 30210005 Exp. 01/31/2023; 30210006 Exp. 01/31/2023; 30210014 Exp. 02/28/2023; 30210022 Exp. 02/28/2023; 30210028 Exp. 02/28/2023; 30210029 Exp. 02/28/2023; 30210030 Exp. 02/28/2023; 30210031 Exp. 02/28/2023",
      "more_code_info": ""
    }
  ]
}