{
  "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": "Piscataway",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA205740"
        ],
        "brand_name": [
          "ENTECAVIR"
        ],
        "generic_name": [
          "ENTECAVIR"
        ],
        "manufacturer_name": [
          "Camber Pharmaceuticals, Inc."
        ],
        "product_ndc": [
          "31722-833",
          "31722-834"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ENTECAVIR ANHYDROUS"
        ],
        "rxcui": [
          "485434",
          "485436"
        ],
        "spl_id": [
          "2b442999-71b5-88f6-e063-6394a90a9d6e"
        ],
        "spl_set_id": [
          "01ec50a1-6c6c-46f0-8c74-73542b0a59c3"
        ],
        "package_ndc": [
          "31722-833-30",
          "31722-833-90",
          "31722-833-31",
          "31722-833-32",
          "31722-834-30",
          "31722-834-90",
          "31722-834-31",
          "31722-834-32"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000175656",
          "N0000175459",
          "N0000009947"
        ],
        "pharm_class_epc": [
          "Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]"
        ],
        "pharm_class_moa": [
          "Nucleoside Reverse Transcriptase Inhibitors [MoA]"
        ],
        "unii": [
          "NNU2O4609D"
        ]
      },
      "product_type": "Drugs",
      "event_id": "77846",
      "recalling_firm": "Hetero USA Inc",
      "address_1": "1035 Centennial Ave",
      "address_2": "N/A",
      "postal_code": "08854-4124",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "NJ",
      "recall_number": "D-1095-2017",
      "product_description": "Entecavir Tablets 0.5 mg, 30 tablets per container, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854. By: Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India. NDC 31722-833-30",
      "product_quantity": "5664 bottles",
      "reason_for_recall": "Failed Impurities/Degradation Specification: single unknown impurity OOS 0.33% (Limit:NMT 0.20%W/W) at the three month stability point.",
      "recall_initiation_date": "20170720",
      "center_classification_date": "20170816",
      "termination_date": "20190227",
      "report_date": "20170823",
      "code_info": "Lot # ENT17008, Exp 01/2019"
    }
  ]
}