{
  "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": "Jadcherla Mandal, Mahaboob Nagar",
      "state": "",
      "country": "India",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA205166"
        ],
        "brand_name": [
          "VALGANCICLOVIR"
        ],
        "generic_name": [
          "VALGANCICLOVIR"
        ],
        "manufacturer_name": [
          "Camber Pharmaceuticals, Inc."
        ],
        "product_ndc": [
          "31722-832"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "VALGANCICLOVIR HYDROCHLORIDE"
        ],
        "rxcui": [
          "313566"
        ],
        "spl_id": [
          "2b44d151-5b10-9250-e063-6294a90a53c2"
        ],
        "spl_set_id": [
          "383e8810-b877-4a4f-abdf-c8c4c8e394f8"
        ],
        "package_ndc": [
          "31722-832-60",
          "31722-832-31",
          "31722-832-32"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0331722832601"
        ],
        "unii": [
          "4P3T9QF9NZ"
        ]
      },
      "product_type": "Drugs",
      "event_id": "79142",
      "recalling_firm": "Hetero Labs Limited Unit V",
      "address_1": "Unit V (SEZ Unit I in APIIC SEZ)",
      "address_2": "Surv. No. 439-441, 458, Polepally Vill.",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "NJ and then distributed Nationwide in the USA",
      "recall_number": "D-0601-2018",
      "product_description": "Valganciclovir Tablets, USP, 450 mg, 60-count bottle, Rx Only,   Manufactured for Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, By: Hetero Hetero Labs Limit Unit V Pollypally Jadcherla Mahaboob Nagar - 509 301 India. NDC # 31722-832-60",
      "product_quantity": "1764 60-count bottles",
      "reason_for_recall": "Temperature Abuse: Valganciclovir Tablets USP 450 mg and  Valacyclovir Tablets USP 1 gram were exposed to higher temperature at airport or cargo and in the same consignment of Famciclovir complaint batch (D-0415-2018).",
      "recall_initiation_date": "20180213",
      "center_classification_date": "20180316",
      "termination_date": "20210218",
      "report_date": "20180321",
      "code_info": "Lot #s VGC17040 & VGC17041, EXP 07/2019",
      "more_code_info": ""
    }
  ]
}