{
  "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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    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Mahwah",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA215822"
        ],
        "brand_name": [
          "FAMOTIDINE"
        ],
        "generic_name": [
          "FAMOTIDINE"
        ],
        "manufacturer_name": [
          "GLENMARK THERAPEUTICS INC., USA"
        ],
        "product_ndc": [
          "72657-112",
          "72657-113",
          "72657-132"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "FAMOTIDINE"
        ],
        "rxcui": [
          "199047",
          "310273"
        ],
        "spl_id": [
          "5502899d-30bd-4954-8aae-9ab1c034f65f"
        ],
        "spl_set_id": [
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        "package_ndc": [
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          "72657-112-20",
          "72657-113-88",
          "72657-113-20",
          "72657-132-01"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0372657132015",
          "0372657112901",
          "0372657113885"
        ],
        "nui": [
          "N0000000151",
          "N0000175784"
        ],
        "pharm_class_moa": [
          "Histamine H2 Receptor Antagonists [MoA]"
        ],
        "pharm_class_epc": [
          "Histamine-2 Receptor Antagonist [EPC]"
        ],
        "unii": [
          "5QZO15J2Z8"
        ]
      },
      "product_type": "Drugs",
      "event_id": "92565",
      "recalling_firm": "Glenmark Therapeutics, Inc.",
      "address_1": "750 Corporate Dr",
      "address_2": "N/A",
      "postal_code": "07430-2009",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "N/A",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0939-2023",
      "product_description": "Famotidine Tablets, USP, 20mg, 200-count bottle within a carton, Distributed by: Glenmark Therapeutics Inc., USA,  Mahwah, NJ 07430, Made in India, NDC 72657-113-20.",
      "product_quantity": "19,968 bottles",
      "reason_for_recall": "Labeling: Label Error on Declared Strength: some cartons labeled and containing 20 mg may have an external label placed on the side of the carton indicating strength as 10 mg.",
      "recall_initiation_date": "20230501",
      "center_classification_date": "20230721",
      "termination_date": "20240917",
      "report_date": "20230726",
      "code_info": "FA2022001B, Exp 03/2025",
      "more_code_info": ""
    }
  ]
}