{
  "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": [
          "ANDA203047"
        ],
        "brand_name": [
          "VALACYCLOVIR"
        ],
        "generic_name": [
          "VALACYCLOVIR"
        ],
        "manufacturer_name": [
          "Camber Pharmaceuticals, Inc."
        ],
        "product_ndc": [
          "31722-704",
          "31722-705"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "VALACYCLOVIR HYDROCHLORIDE"
        ],
        "rxcui": [
          "313564",
          "313565"
        ],
        "spl_id": [
          "461ff6f2-7bf1-82fb-e063-6294a90acb06"
        ],
        "spl_set_id": [
          "7f5e96e0-534c-47a5-bb79-926088afc73c"
        ],
        "package_ndc": [
          "31722-704-30",
          "31722-704-60",
          "31722-704-90",
          "31722-704-01",
          "31722-704-05",
          "31722-704-31",
          "31722-704-32",
          "31722-705-30",
          "31722-705-60",
          "31722-705-90",
          "31722-705-01",
          "31722-705-05"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0331722704304",
          "0331722705301"
        ],
        "unii": [
          "G447S0T1VC"
        ]
      },
      "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-0602-2018",
      "product_description": "Valacyclovir Tablets USP 1 gram, 30-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 # 31722-705-30",
      "product_quantity": "48132 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 # VLC17027 Exp 07-2019",
      "more_code_info": ""
    }
  ]
}