{
  "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 II",
      "openfda": {
        "application_number": [
          "ANDA090019"
        ],
        "brand_name": [
          "GAVILYTE-N"
        ],
        "generic_name": [
          "POLYETHYLENE GLYCOL-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE AND SODIUM BICARBONATE"
        ],
        "manufacturer_name": [
          "Lupin Pharmaceuticals,Inc."
        ],
        "product_ndc": [
          "43386-050"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "POLYETHYLENE GLYCOL 3350",
          "POTASSIUM CHLORIDE",
          "SODIUM BICARBONATE",
          "SODIUM CHLORIDE"
        ],
        "rxcui": [
          "801054",
          "979099"
        ],
        "spl_id": [
          "3839c7fd-e7c4-45c6-ae02-0302b40046b0"
        ],
        "spl_set_id": [
          "27195187-75a3-431f-90d9-84da1b94e849"
        ],
        "package_ndc": [
          "43386-050-19",
          "3433860501",
          "3433862000",
          "3433862020",
          "3433862034"
        ],
        "is_original_packager": [
          true
        ],
        "nui": [
          "N0000010288",
          "N0000175811",
          "N0000009871"
        ],
        "pharm_class_moa": [
          "Osmotic Activity [MoA]"
        ],
        "pharm_class_epc": [
          "Osmotic Laxative [EPC]"
        ],
        "pharm_class_pe": [
          "Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"
        ],
        "unii": [
          "G2M7P15E5P",
          "660YQ98I10",
          "8MDF5V39QO",
          "451W47IQ8X"
        ],
        "upc": [
          "343386050192",
          "343386200023",
          "343386202027"
        ]
      },
      "product_type": "Drugs",
      "event_id": "82396",
      "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": "Nationwide",
      "recall_number": "D-1113-2019",
      "product_description": "Gavilyte-N, PEG-3350, Sodium chloride, Sodium Bicarbonate and Potassium Chloride for Oral Solution, Rx only, Manufactured by Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for Lupin Pharmaceuticals, Inc. Baltimore, MD NDC 43386-050-19  UPC 343386050192    a) Lemon Flavor Pack net wt. 2 g UPC 343386200023  b) Orange Flavor Pack net wt. 2 g UPC 343386202027  c) Cherry Flavor Pack net wt. 2 g UPC 3433862034",
      "product_quantity": "76422 bottles",
      "reason_for_recall": "Labeling Not Elsewhere Classified; orange and cherry flavor packets incorrect list \"natural lemon flavor\" as an ingredient",
      "recall_initiation_date": "20190319",
      "center_classification_date": "20190409",
      "termination_date": "20220523",
      "report_date": "20190417",
      "code_info": "Lot #: a) S800021, Exp 30-Nov-20; b) S800175, Exp 31-Dec-20; c) S 800401, Exp 28-Feb-21; S800426, Exp 31-Mar-21; S800920, Exp 31-Aug-21."
    }
  ]
}