{
  "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": "2026-09-02",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Shirley",
      "state": "NY",
      "country": "United States",
      "classification": "Class I",
      "openfda": {
        "brand_name": [
          "PAPAVERINE HYDROCHLORIDE"
        ],
        "generic_name": [
          "PAPAVERINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "American Regent, Inc."
        ],
        "product_ndc": [
          "0517-4002"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "PAPAVERINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1789947"
        ],
        "spl_id": [
          "402161da-fe45-4b0f-a5ca-a230593cc434"
        ],
        "spl_set_id": [
          "9e5e2ce4-7a57-4c61-a826-64c8d11d038e"
        ],
        "package_ndc": [
          "0517-4002-01",
          "0517-4002-25"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0305174002257"
        ],
        "unii": [
          "23473EC6BQ"
        ]
      },
      "product_type": "Drugs",
      "event_id": "99503",
      "recalling_firm": "American Regent, Inc.",
      "address_1": "5 Ramsay Rd",
      "address_2": "",
      "postal_code": "11967-4701",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Press Release",
      "distribution_pattern": "Nationwide within the U.S",
      "recall_number": "D-0800-2026",
      "product_description": "Papaverine HCl Injection, USP, 60 mg/2 mL (30 mg/mL), packaged in a) 2mL Single-Dose Vial (NDC 0517-4002-01), and b) 25x2mL Single-Dose Vials (NDC 0517-4002-25), Rx Only, AMERICAN REGENT, INC., SHIRLEY, NY 11967.",
      "product_quantity": "86,100 vials",
      "reason_for_recall": "Presence of Particulate Matter: Product contaminated with particulate matter identified as glass and/or paraformaldehyde",
      "recall_initiation_date": "20260724",
      "center_classification_date": "20260826",
      "report_date": "20260826",
      "code_info": "Lot #: 25202, Exp. Date: 11/30/2026.",
      "more_code_info": ""
    }
  ]
}