{
  "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": "2026-07-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Somerset",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "ANDA090186"
        ],
        "brand_name": [
          "GAVILYTE - C"
        ],
        "generic_name": [
          "POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES WITH FLAVOR PACK"
        ],
        "manufacturer_name": [
          "Lupin Pharmaceuticals,Inc."
        ],
        "product_ndc": [
          "43386-060"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "POLYETHYLENE GLYCOL 3350",
          "SODIUM CHLORIDE",
          "POTASSIUM CHLORIDE",
          "SODIUM BICARBONATE",
          "SODIUM SULFATE ANHYDROUS"
        ],
        "rxcui": [
          "966914",
          "967023"
        ],
        "spl_id": [
          "5105b61a-4ca7-4096-9cd0-cf22f46ffaf8"
        ],
        "spl_set_id": [
          "a8b15625-ca7c-4d57-9f36-3ac2a6d13665"
        ],
        "package_ndc": [
          "43386-060-19"
        ],
        "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",
          "451W47IQ8X",
          "660YQ98I10",
          "8MDF5V39QO",
          "36KCS0R750"
        ]
      },
      "product_type": "Drugs",
      "event_id": "88390",
      "recalling_firm": "Novel Laboratories, Inc. d.b.a LUPIN",
      "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-0726-2021",
      "product_description": "GaviLyteTM - C PEG-3350 (240g) and Electrolytes for Oral Solution, USP with Flavor Pack Manufactured by Novel Laboratories, Inc. Somerset, NJ 08873, USA Manufactured for Lupin Pharmaceuticals, Inc. Baltimore, MD 21202  NDC  43386-060-19",
      "product_quantity": "20,814 bottles",
      "reason_for_recall": "Failed Stability Specification; Out of specification for Osmolarity",
      "recall_initiation_date": "20210729",
      "center_classification_date": "20210813",
      "termination_date": "20221114",
      "report_date": "20210825",
      "code_info": "Lot S001133, exp 7/2022"
    }
  ]
}