{
  "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,
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    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "North Wales",
      "state": "PA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA205220"
        ],
        "brand_name": [
          "VALGANCICLOVIR HYDROCHLORIDE FOR ORAL"
        ],
        "generic_name": [
          "VALGANCICLOVIR HYDROCHLORIDE"
        ],
        "manufacturer_name": [
          "Actavis Pharma, Inc."
        ],
        "product_ndc": [
          "0591-2579"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "VALGANCICLOVIR HYDROCHLORIDE"
        ],
        "rxcui": [
          "863559"
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        "spl_id": [
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        ],
        "spl_set_id": [
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        "package_ndc": [
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        ],
        "is_original_packager": [
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        ],
        "unii": [
          "4P3T9QF9NZ"
        ]
      },
      "product_type": "Drugs",
      "event_id": "84242",
      "recalling_firm": "Teva Pharmaceuticals USA, Inc.",
      "address_1": "1090 Horsham Rd",
      "address_2": "N/A",
      "postal_code": "19454-1505",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Product was distributed to wholesalers/distributors throughout the United States.",
      "recall_number": "D-0518-2020",
      "product_description": "Valganciclovir Hydrochloride for Oral Solution, 50 mg/mL, 100 mL (3.4 fl. oz.) bottle, Rx only, Manufactured for: Actavis Laboratories FL. Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 0591-2579-20",
      "product_quantity": "3,623 bottles",
      "reason_for_recall": "Presence of foreign substance: Brown/black particles found during stability testing.",
      "recall_initiation_date": "20191104",
      "center_classification_date": "20191121",
      "termination_date": "20201117",
      "report_date": "20191127",
      "code_info": "Lot #: CBFCN,  CBHFG, Exp 05/2020"
    }
  ]
}