{
  "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,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Campbell",
      "state": "CA",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "BLA022523"
        ],
        "brand_name": [
          "PANCREAZE"
        ],
        "generic_name": [
          "PANCRELIPASE LIPASE, PANCRELIPASE AMYLASE, AND PANCRELIPASE PROTEASE"
        ],
        "manufacturer_name": [
          "VIVUS LLC"
        ],
        "product_ndc": [
          "62541-401",
          "62541-402",
          "62541-403",
          "62541-404",
          "62541-405",
          "62541-406"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "PANCRELIPASE LIPASE",
          "PANCRELIPASE AMYLASE",
          "PANCRELIPASE PROTEASE"
        ],
        "rxcui": [
          "1806919",
          "1806921",
          "1806924",
          "1806926",
          "1806929",
          "1806931",
          "1806964",
          "1806966",
          "2478453",
          "2478455",
          "2564410",
          "2564412"
        ],
        "spl_id": [
          "36e934b1-3fbb-8f0c-e063-6294a90a968c"
        ],
        "spl_set_id": [
          "e8f5d2fe-728d-42af-99a6-83dddc6539c5"
        ],
        "package_ndc": [
          "62541-402-10",
          "62541-403-10",
          "62541-404-10",
          "62541-405-10",
          "62541-401-10",
          "62541-406-50",
          "62541-406-10"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0362541402102",
          "0362541403109",
          "0362541405103",
          "0362541401105",
          "0362541406100",
          "0362541404106",
          "362541401105"
        ],
        "unii": [
          "8MYC33932O",
          "3560D81V50",
          "YOJ58O116E"
        ]
      },
      "product_type": "Drugs",
      "event_id": "92582",
      "recalling_firm": "Vivus, Inc.",
      "address_1": "900 E Hamilton Ave Ste 550",
      "address_2": "N/A",
      "postal_code": "95008-0643",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "N/A",
      "distribution_pattern": "Nationwide within the United States",
      "recall_number": "D-0896-2023",
      "product_description": "PANCREAZE (pancrelipase) Delayed-Release Capsules, 100-count bottles, Rx only, Rx only, Manufactured by VIVUS LLC, Campbell, CA 95008, UPC: N3 62541-401-10 5, NDC 62541-401-10,",
      "product_quantity": "4240 bottles",
      "reason_for_recall": "Failed Stability Specifications",
      "recall_initiation_date": "20230623",
      "center_classification_date": "20230707",
      "report_date": "20230719",
      "code_info": "Lot #: 102101, Exp: 31 July 2024",
      "more_code_info": ""
    }
  ]
}