{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "East Brunswick",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA202501"
        ],
        "brand_name": [
          "CIDOFOVIR DIHYDRATE"
        ],
        "generic_name": [
          "CIDOFOVIR DIHYDRATE"
        ],
        "manufacturer_name": [
          "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc."
        ],
        "product_ndc": [
          "23155-216"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "CIDOFOVIR"
        ],
        "rxcui": [
          "199388"
        ],
        "spl_id": [
          "963405a6-8cd9-4d70-9de9-2afc6eab1488"
        ],
        "spl_set_id": [
          "44966a7e-d777-40fb-956f-d0f31f737848"
        ],
        "package_ndc": [
          "23155-216-31",
          "3231552163"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0323155216318"
        ],
        "unii": [
          "JIL713Q00N"
        ]
      },
      "product_type": "Drugs",
      "event_id": "81276",
      "recalling_firm": "Heritage Pharmaceuticals, Inc.",
      "address_1": "1 Tower Center Blvd Ste 1700",
      "address_2": "N/A",
      "postal_code": "08816-1145",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide within the United States",
      "recall_number": "D-0094-2019",
      "product_description": "Cidofovir injection 375 mg/mL (75 mg/mL) vial Injection, 5 mL vials, Rx Only, Mfg. By Emcure Pharmaceutical Ltd Hinjawadi, Pune, India, Mfg for: Heritage Pharmaceuticals Inc. UPC 323155216388, NDC 23155-216-31",
      "product_quantity": "2,789 Units",
      "reason_for_recall": "Lack of Assurance of Sterility: complaints received about dried powder on the outside of the bottle",
      "recall_initiation_date": "20181015",
      "center_classification_date": "20181024",
      "termination_date": "20230329",
      "report_date": "20181031",
      "code_info": "Lot #: VCIA083, Exp. JUN2020"
    }
  ]
}