{
  "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": "Pennington",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA204314"
        ],
        "brand_name": [
          "ACYCLOVIR"
        ],
        "generic_name": [
          "ACYCLOVIR"
        ],
        "manufacturer_name": [
          "Zydus Pharmaceuticals (USA) Inc."
        ],
        "product_ndc": [
          "68382-791",
          "68382-792"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ACYCLOVIR"
        ],
        "rxcui": [
          "197311",
          "197313"
        ],
        "spl_id": [
          "d8791a7b-225c-4f2e-9023-1a1932b0f7d7"
        ],
        "spl_set_id": [
          "edb0cd28-ee57-4b60-be94-62c797fbf5e6"
        ],
        "package_ndc": [
          "68382-791-06",
          "68382-791-16",
          "68382-791-01",
          "68382-791-05",
          "68382-791-10",
          "68382-791-30",
          "68382-792-06",
          "68382-792-16",
          "68382-792-01",
          "68382-792-05",
          "68382-792-10",
          "68382-792-30"
        ],
        "is_original_packager": [
          true
        ],
        "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": "82714",
      "recalling_firm": "Zydus Pharmaceuticals USA Inc",
      "address_1": "73 Route 31 N",
      "address_2": "N/A",
      "postal_code": "08534-3601",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide",
      "recall_number": "D-1272-2019",
      "product_description": "Acyclovir Tablets, USP, 400 mg, 100 count bottles, Rx Only Manufactured by: Cadila Healthcare Ltd., India Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ USA 08534  NDC 68382-791-01",
      "product_quantity": "N/A",
      "reason_for_recall": "Labeling; Label Mix-up; report received of one bottle labeled as Acyclovir Tablets USP 400 mg actually contained Carvedilol Tablets 6.25 mg",
      "recall_initiation_date": "20190425",
      "center_classification_date": "20190507",
      "termination_date": "20210629",
      "report_date": "20190515",
      "code_info": "Z804517, Nov 30, 2020"
    }
  ]
}