{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Mahwah",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA210264"
        ],
        "brand_name": [
          "ESTRADIOL VAGINAL INSERTS"
        ],
        "generic_name": [
          "ESTRADIOL"
        ],
        "manufacturer_name": [
          "Glenmark Pharmaceuticals Inc., USA"
        ],
        "product_ndc": [
          "68462-711"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "VAGINAL"
        ],
        "substance_name": [
          "ESTRADIOL"
        ],
        "rxcui": [
          "884707"
        ],
        "spl_id": [
          "732fcf7c-ebfa-4c6d-a06e-5e2ed8d90ef7"
        ],
        "spl_set_id": [
          "86620f6c-fd02-40df-98d5-3048dcd92c37"
        ],
        "package_ndc": [
          "68462-711-71",
          "68462-711-88"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0368462711880",
          "0368462711712"
        ],
        "nui": [
          "M0447348",
          "N0000175825",
          "N0000000100"
        ],
        "pharm_class_cs": [
          "Estradiol Congeners [CS]"
        ],
        "pharm_class_epc": [
          "Estrogen [EPC]"
        ],
        "pharm_class_moa": [
          "Estrogen Receptor Agonists [MoA]"
        ],
        "unii": [
          "4TI98Z838E"
        ]
      },
      "product_type": "Drugs",
      "event_id": "81876",
      "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": "Product was distributed to 5 retailers and 4 distributors throughout the United States who may have further distributed the recalled product.",
      "recall_number": "D-0350-2019",
      "product_description": "Estradiol Vaginal Inserts, USP, 10 mcg, Rx only, packaged in a) 8 count (NDC 68462-711-71) and b) 18 count (NDC 68462-711-88) cartons, Manufactured by: Glenmark Pharmaceuticals, Ltd., Colvale, Goa India, Manufactured for: Glenmark Pharmaceuticals, Inc., USA Mahwah, NJ",
      "product_quantity": "96,240 applicators",
      "reason_for_recall": "Defective Delivery System: Customer complaints of malfunctioning plunger of the applicator",
      "recall_initiation_date": "20181226",
      "center_classification_date": "20190108",
      "termination_date": "20201006",
      "report_date": "20190116",
      "code_info": "Batch numbers:    a)  20180393, exp. date 01/31/2020,   20180424, exp. date 02/29/2020,   20180425, exp. date 02/29/2020,   20180427, exp. date 02/29/2020;     b)  20180338, exp. date 12/31/2019,   20180386, exp. date 01/31/2020",
      "more_code_info": ""
    }
  ]
}