{
  "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": "Somerset",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA206245"
        ],
        "brand_name": [
          "HYDROCODONE BITARTRATE AND ACETAMINOPHEN"
        ],
        "generic_name": [
          "HYDROCODONE BITARTRATE AND ACETAMINOPHEN"
        ],
        "manufacturer_name": [
          "Lupin Pharmaceuticals,Inc."
        ],
        "product_ndc": [
          "43386-356",
          "43386-358",
          "43386-357"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ACETAMINOPHEN",
          "HYDROCODONE BITARTRATE"
        ],
        "rxcui": [
          "856999",
          "857002",
          "857005"
        ],
        "spl_id": [
          "2cb73d19-0ef9-4d59-a2de-b7b2b3a369a1"
        ],
        "spl_set_id": [
          "26a2178e-e0e5-4d61-81fd-e30a3142f1f2"
        ],
        "package_ndc": [
          "43386-358-05",
          "43386-358-01",
          "43386-358-10",
          "43386-358-03",
          "43386-357-01",
          "43386-357-05",
          "43386-357-10",
          "43386-357-03",
          "43386-356-01",
          "43386-356-05",
          "43386-356-10",
          "43386-356-03",
          "3433863561"
        ],
        "is_original_packager": [
          true
        ],
        "upc": [
          "0343386357031",
          "0343386358014",
          "0343386356010",
          "343386356102"
        ],
        "unii": [
          "NO70W886KK",
          "362O9ITL9D"
        ]
      },
      "product_type": "Drugs",
      "event_id": "80187",
      "recalling_firm": "LUPIN SOMERSET",
      "address_1": "400 Campus Dr",
      "address_2": "N/A",
      "postal_code": "08873-1145",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "OH",
      "recall_number": "D-0836-2018",
      "product_description": "Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 5 mg/325 mg, 1000-count bottle Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset NJ 08873  Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 212020  NDC 43386-356-10  UPC 343386356102",
      "product_quantity": "1,672 (1000-count) bottles",
      "reason_for_recall": "Labeling: Missing Label",
      "recall_initiation_date": "20180524",
      "center_classification_date": "20180531",
      "termination_date": "20210126",
      "report_date": "20180606",
      "code_info": "Lot # S800257; Exp. 01/20"
    }
  ]
}