{
  "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": "2026-07-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Completed",
      "city": "Canonsburg",
      "state": "PA",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA078518"
        ],
        "brand_name": [
          "VALACYCLOVIR HYDROCHLORIDE"
        ],
        "generic_name": [
          "VALACYCLOVIR"
        ],
        "manufacturer_name": [
          "Mylan Pharmaceuticals Inc."
        ],
        "product_ndc": [
          "0378-4275",
          "0378-4276"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "VALACYCLOVIR HYDROCHLORIDE"
        ],
        "rxcui": [
          "313564",
          "313565"
        ],
        "spl_id": [
          "7de6158d-06ad-4500-a485-dafc151c16ff"
        ],
        "spl_set_id": [
          "56bf715d-8280-4557-9f98-9693932199e5"
        ],
        "package_ndc": [
          "0378-4275-93",
          "0378-4275-77",
          "0378-4276-93",
          "0378-4276-77"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0303784276938",
          "0303784275931"
        ],
        "unii": [
          "G447S0T1VC"
        ]
      },
      "product_type": "Drugs",
      "event_id": "94482",
      "recalling_firm": "Viatris Inc",
      "address_1": "1000 Mylan Blvd",
      "address_2": "",
      "postal_code": "15317-5853",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide within the united states",
      "recall_number": "D-0481-2024",
      "product_description": "Valacyclovir Tablets USP, 500 mg, 90 count bottles, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 USA, NDC 0378-4275-77",
      "product_quantity": "143,230 bottles",
      "reason_for_recall": "Failed Tablet/Capsule Specifications: There is a potential for the imprint, M 122, to be missing on some tablets.",
      "recall_initiation_date": "20240425",
      "center_classification_date": "20240502",
      "report_date": "20240508",
      "code_info": "Lot #: 3183269, Exp. Date May 2025; 3157326, Exp. date June 2024",
      "more_code_info": ""
    }
  ]
}