{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "San Diego",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "brand_name": [
          "PAPAVERINE HYDROCHLORIDE"
        ],
        "generic_name": [
          "PAPAVERINE HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Oryza Pharmaceuticals Inc."
        ],
        "product_ndc": [
          "72516-024"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "PAPAVERINE HYDROCHLORIDE"
        ],
        "rxcui": [
          "1789947"
        ],
        "spl_id": [
          "2b4bd8c6-2b93-d435-e063-6394a90ae742"
        ],
        "spl_set_id": [
          "5ba6e650-a5b5-4381-a62a-b7a6df73e8e6"
        ],
        "package_ndc": [
          "72516-024-25",
          "72516-024-10"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "23473EC6BQ"
        ]
      },
      "product_type": "Drugs",
      "event_id": "89803",
      "recalling_firm": "Vitae Enim Vitae Scientific, Inc.",
      "address_1": "3030 Bunker Hill St Ste 203",
      "address_2": "",
      "postal_code": "92109-5754",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "distribution_pattern": "Nationwide in the U.S.A",
      "recall_number": "D-0742-2022",
      "product_description": "PAPAVERINE HYDROCHLORIDE Injection, USP, 60 mg/2mL (30 mg/mL), packaged as a) 25 x 2mL Single Use Vials per box (NDC 72516-024-25) and b) 10 x 2mL Single Use Vials per box (NDC 72516-024-10); Manufactured for Oryza Pharmaceuticals, Inc.",
      "product_quantity": "a) 2,098 boxes; b) 700 boxes",
      "reason_for_recall": "Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.",
      "recall_initiation_date": "20220314",
      "center_classification_date": "20220405",
      "termination_date": "20240815",
      "report_date": "20220413",
      "code_info": "Lot #: a) 20VPHI037, 20VPHI038, 20VPHI039, Exp 12/31/2022; 21VPHI021, 21VPHI022, 21VPHI023, Exp 6/30/2023; 21VPHI047, 21VPHI048, Exp 10/31/2023; b) 21VPHI023, Exp 6/30/2023",
      "more_code_info": ""
    }
  ]
}