{
  "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": "Panchmahal",
      "state": "",
      "country": "India",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA204973"
        ],
        "brand_name": [
          "FESOTERODINE FUMARATE"
        ],
        "generic_name": [
          "FESOTERODINE FUMARATE"
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        "manufacturer_name": [
          "Alembic Pharmaceuticals Inc."
        ],
        "product_ndc": [
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          "62332-176"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
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        ],
        "substance_name": [
          "FESOTERODINE FUMARATE"
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        "rxcui": [
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          "810077"
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        "spl_id": [
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        "spl_set_id": [
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        "package_ndc": [
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          "62332-175-90",
          "62332-175-91",
          "62332-175-10",
          "62332-176-30",
          "62332-176-90",
          "62332-176-91",
          "62332-176-10",
          "2405006633"
        ],
        "is_original_packager": [
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        "upc": [
          "0362332176304",
          "0362332175307"
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        "unii": [
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      },
      "product_type": "Drugs",
      "event_id": "97812",
      "recalling_firm": "Alembic Pharmaceuticals Limited",
      "address_1": "Formulation Division, Village Panelav, P.O. Tajpura, Near Baska, Taluka Halol",
      "address_2": "",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "distribution_pattern": "Nationwide in the USA.",
      "recall_number": "D-0156-2026",
      "product_description": "Fesoterodine Fumarate, Extended-release Tablets, 4 mg, 30-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panelav 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-175-30",
      "product_quantity": "4,884 30-count bottles",
      "reason_for_recall": "Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.",
      "recall_initiation_date": "20251010",
      "center_classification_date": "20251114",
      "report_date": "20251126",
      "code_info": "Lot # 2405006633, Exp Date: 03/31/2026",
      "more_code_info": ""
    }
  ]
}