{
  "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": "Fountain Run",
      "state": "KY",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA075382"
        ],
        "brand_name": [
          "ACYCLOVIR"
        ],
        "generic_name": [
          "ACYCLOVIR"
        ],
        "manufacturer_name": [
          "AvPAK"
        ],
        "product_ndc": [
          "50268-061",
          "50268-062"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ACYCLOVIR"
        ],
        "rxcui": [
          "197311",
          "197313"
        ],
        "spl_id": [
          "47e22393-03a9-791e-e063-6294a90aa89a"
        ],
        "spl_set_id": [
          "6e203fa9-ee97-1e08-8d6a-fb57cfa13e19"
        ],
        "package_ndc": [
          "50268-061-11",
          "50268-061-15",
          "50268-062-11",
          "50268-062-15"
        ],
        "original_packager_product_ndc": [
          "61442-112",
          "61442-113"
        ],
        "nui": [
          "N0000020060",
          "N0000180187",
          "N0000180188",
          "N0000175468",
          "N0000175459"
        ],
        "pharm_class_moa": [
          "DNA Polymerase Inhibitors [MoA]"
        ],
        "pharm_class_epc": [
          "Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC]",
          "Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC]",
          "Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC]"
        ],
        "unii": [
          "X4HES1O11F"
        ]
      },
      "product_type": "Drugs",
      "event_id": "79194",
      "recalling_firm": "Apace KY LLC",
      "address_1": "12954 Fountain Run Rd",
      "address_2": "N/A",
      "postal_code": "42133-7914",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-0544-2018",
      "product_description": "Acyclovir Tablets, USP, 400 mg, 50 Tablets (5 x 10) unit dose blisters [NDC 50268-061-11] per carton [NDC 50268-061-15], Rx Only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478",
      "product_quantity": "630 cartons",
      "reason_for_recall": "Presence of Foreign Tablet/Capsule; cartons labeled to contain Acyclovir tablets may contain Torsemide tablets in some of the blister cavities.",
      "recall_initiation_date": "20180209",
      "center_classification_date": "20180223",
      "termination_date": "20190910",
      "report_date": "20180307",
      "code_info": "Lot: 19900, exp 05/2019"
    }
  ]
}