{
  "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": "Columbus",
      "state": "OH",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA074415"
        ],
        "brand_name": [
          "SUCRALFATE"
        ],
        "generic_name": [
          "SUCRALFATE"
        ],
        "manufacturer_name": [
          "American Health Packaging"
        ],
        "product_ndc": [
          "60687-695"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "SUCRALFATE"
        ],
        "rxcui": [
          "314234"
        ],
        "spl_id": [
          "37dbc9fb-25b5-30a2-e063-6294a90a78b8"
        ],
        "spl_set_id": [
          "e7364686-3638-4061-ae4a-62b1df7af9d0"
        ],
        "package_ndc": [
          "60687-695-11",
          "60687-695-01"
        ],
        "original_packager_product_ndc": [
          "29033-003"
        ],
        "nui": [
          "N0000175801",
          "M0015420"
        ],
        "pharm_class_epc": [
          "Aluminum Complex [EPC]"
        ],
        "pharm_class_cs": [
          "Organometallic Compounds [CS]"
        ],
        "unii": [
          "XX73205DH5"
        ]
      },
      "product_type": "Drugs",
      "event_id": "97361",
      "recalling_firm": "Amerisource Health Services LLC",
      "address_1": "2550 John Glenn Ave Ste A",
      "address_2": "",
      "postal_code": "43217-1188",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-0598-2025",
      "product_description": "Sucralfate Tablets, USP 1 gram, 100 Tablets, (10x10), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217 NDC 60687-695-01 - Carton NDC [60687-695-11- Unit Dose]",
      "product_quantity": "26,992 blister packs",
      "reason_for_recall": "CGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.",
      "recall_initiation_date": "20250729",
      "center_classification_date": "20250822",
      "report_date": "20250903",
      "code_info": "Lot 1015038, Exp Date 07/31/2025, Lot 1015898, Exp Date 09/30/2025; Lot 1016873, Exp Date 10/31/2025 and Lot 1023398, Exp Date 07/31/2026.",
      "more_code_info": ""
    }
  ]
}