{
  "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": [
          "ANDA202438"
        ],
        "brand_name": [
          "FAMCICLOVIR"
        ],
        "generic_name": [
          "FAMCICLOVIR"
        ],
        "manufacturer_name": [
          "Camber Pharmaceuticals, Inc."
        ],
        "product_ndc": [
          "31722-706",
          "31722-707",
          "31722-708"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "FAMCICLOVIR"
        ],
        "rxcui": [
          "198382",
          "199192",
          "199193"
        ],
        "spl_id": [
          "2b438049-f70c-5388-e063-6394a90af892"
        ],
        "spl_set_id": [
          "08c58224-5920-4853-8c59-ec5fbb66c2f6"
        ],
        "package_ndc": [
          "31722-706-30",
          "31722-706-60",
          "31722-706-01",
          "31722-706-05",
          "31722-706-10",
          "31722-707-30",
          "31722-707-60",
          "31722-707-01",
          "31722-707-05",
          "31722-707-10",
          "31722-708-30",
          "31722-708-60",
          "31722-708-01",
          "31722-708-05",
          "31722-708-10"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000020060",
          "N0000180187",
          "N0000175459"
        ],
        "pharm_class_moa": [
          "DNA Polymerase Inhibitors [MoA]"
        ],
        "pharm_class_epc": [
          "Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC]"
        ],
        "unii": [
          "QIC03ANI02"
        ]
      },
      "product_type": "Drugs",
      "event_id": "78811",
      "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": "Nationwide in the USA.",
      "recall_number": "D-0415-2018",
      "product_description": "Famciclovir Tablets, 500 mg, 30-count bottles, Rx Only, Manufactured For: Camber Pharmaceuticals. Inc. Piscataway, NJ 08854 By: HETERO, Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar-509 301, India. NDC 31722-708-30",
      "product_quantity": "8,436 bottles",
      "reason_for_recall": "Temperature Abuse: Complaints of tablets being wet and stuck together with tablet coating peeled and disintegrated as a result of prolonged exposure to high temp during distribution.",
      "recall_initiation_date": "20171222",
      "center_classification_date": "20180215",
      "termination_date": "20200205",
      "report_date": "20180221",
      "code_info": "Lot # FMC17039, Exp 07/2019.",
      "more_code_info": ""
    }
  ]
}