{
  "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": "Lake Zurich",
      "state": "IL",
      "country": "United States",
      "classification": "Class I",
      "openfda": {
        "application_number": [
          "ANDA075813"
        ],
        "brand_name": [
          "FAMOTIDINE"
        ],
        "generic_name": [
          "FAMOTIDINE"
        ],
        "manufacturer_name": [
          "Fresenius Kabi USA, LLC"
        ],
        "product_ndc": [
          "63323-739"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "FAMOTIDINE"
        ],
        "rxcui": [
          "1743833"
        ],
        "spl_id": [
          "7411dc23-e297-42cb-b491-b90d70c841a3"
        ],
        "spl_set_id": [
          "aeb27cea-1ff7-4a6e-93f1-d4c4dac5faa7"
        ],
        "package_ndc": [
          "63323-739-11",
          "63323-739-12"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0363323739119"
        ],
        "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": "97945",
      "recalling_firm": "Fresenius Kabi USA, LLC",
      "address_1": "3 Corporate Dr",
      "address_2": "N/A",
      "postal_code": "60047-8930",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide within the United States as well as AK, HI, and PR.",
      "recall_number": "D-0182-2026",
      "product_description": "Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL vials, Rx only, Fresenius Kabi USA, LLC, NDC 63323-739-11 (unit of use), 63323-739-12 (unit of sale).",
      "product_quantity": "2,199,850 vials",
      "reason_for_recall": "Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.",
      "recall_initiation_date": "20251106",
      "center_classification_date": "20251126",
      "report_date": "20251203",
      "code_info": "Lot #: 6133156, 6133194, Exp Date: 08/2026; 6133388, Exp Date: 10/2026.",
      "more_code_info": ""
    }
  ]
}