{
  "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 I",
      "openfda": {
        "application_number": [
          "ANDA206535"
        ],
        "brand_name": [
          "ACYCLOVIR"
        ],
        "generic_name": [
          "ACYCLOVIR"
        ],
        "manufacturer_name": [
          "Zydus Pharmaceuticals (USA) Inc."
        ],
        "product_ndc": [
          "68382-048",
          "68382-049"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "ACYCLOVIR SODIUM"
        ],
        "rxcui": [
          "1734932",
          "1734934"
        ],
        "spl_id": [
          "515388e8-636f-42f6-a39e-bb4fc7c2e7cb"
        ],
        "spl_set_id": [
          "69a98000-adef-4323-89a7-09e035a257d4"
        ],
        "package_ndc": [
          "68382-048-01",
          "68382-048-10",
          "68382-049-01",
          "68382-049-10"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "927L42J563"
        ]
      },
      "product_type": "Drugs",
      "event_id": "87364",
      "recalling_firm": "Zydus Pharmaceuticals (USA) Inc",
      "address_1": "73 Route 31 N",
      "address_2": "",
      "postal_code": "08534-3601",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "USA Nationwide",
      "recall_number": "D-0315-2021",
      "product_description": "Acyclovir Sodium Injection 1000mg/20mL (50mg/mL) vial NDC 68382-049-01, For Intravenous Infusion Only MUST BE DILUTED PRIOR TO USE, packaged in 10 x 20mL Single-Dose Vials per pack NDC 68382-049-10, Rx only, Manufactured by: Cadila Healthcare Ltd., Vadodara, India. Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534.",
      "product_quantity": "816  packs",
      "reason_for_recall": "Crystallization: customer complaints for crystallization in finished product.",
      "recall_initiation_date": "20210218",
      "center_classification_date": "20210330",
      "termination_date": "20221123",
      "report_date": "20210407",
      "code_info": "Lot#: L000155, Exp 12/2021; L000156, Exp 1/2022",
      "more_code_info": ""
    }
  ]
}