{
  "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": "Ongoing",
      "city": "East Windsor",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA203701"
        ],
        "brand_name": [
          "ACYCLOVIR SODIUM"
        ],
        "generic_name": [
          "ACYCLOVIR SODIUM"
        ],
        "manufacturer_name": [
          "Eugia US LLC"
        ],
        "product_ndc": [
          "55150-154",
          "55150-155"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "INTRAVENOUS"
        ],
        "substance_name": [
          "ACYCLOVIR SODIUM"
        ],
        "rxcui": [
          "1734932",
          "1734934"
        ],
        "spl_id": [
          "410e306b-e8b9-4ff5-b703-a3005eec272f"
        ],
        "spl_set_id": [
          "ae921e4e-b8ae-4a45-acc1-32e5e719812b"
        ],
        "package_ndc": [
          "55150-154-10",
          "55150-155-20"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0355150155200",
          "0355150154104"
        ],
        "unii": [
          "927L42J563"
        ]
      },
      "product_type": "Drugs",
      "event_id": "91406",
      "recalling_firm": "Eugia US LLC",
      "address_1": "279 Princeton Hightstown Rd",
      "address_2": "N/A",
      "postal_code": "08520-1401",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0095-2023",
      "product_description": "Acyclovir Sodium Injection 1,000 mg per 20 mL* (50 mg/mL); Single Dose 20mL Vial, Rx only,  Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd, E. Windsor, NJ 08520; Made in India. NDC 55150-155-20",
      "product_quantity": "45,250 vials",
      "reason_for_recall": "Presence of Particulate Matter: Customer complaint of dark particles found inside the vial",
      "recall_initiation_date": "20221228",
      "center_classification_date": "20230103",
      "report_date": "20230111",
      "code_info": "Lot # AC22004, Expiry: 08/2023"
    }
  ]
}