{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Somerset",
      "state": "NJ",
      "country": "United States",
      "classification": "Class III",
      "openfda": {
        "application_number": [
          "ANDA090145"
        ],
        "brand_name": [
          "PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID"
        ],
        "generic_name": [
          "PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID"
        ],
        "manufacturer_name": [
          "Teva Pharmaceuticals USA, Inc."
        ],
        "product_ndc": [
          "0093-3560"
        ],
        "product_type": [
          "HUMAN PRESCRIPTION DRUG"
        ],
        "rxcui": [
          "800915"
        ],
        "spl_id": [
          "46e37694-3149-46b3-a949-fad3ccbb8052"
        ],
        "spl_set_id": [
          "475a06c6-f295-406c-a110-f1497cf51566"
        ],
        "package_ndc": [
          "0093-3560-19",
          "0093-3560-26",
          "0093-9044-19",
          "0093-9043-19"
        ],
        "is_original_packager": [
          true
        ]
      },
      "product_type": "Drugs",
      "event_id": "94924",
      "recalling_firm": "Novel Laboratories, Inc. d.b.a Lupin Somerset",
      "address_1": "400 Campus Dr",
      "address_2": "",
      "postal_code": "08873-1145",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the US.",
      "recall_number": "D-0628-2024",
      "product_description": "PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution 100g/7.5 g /2.691 g/1.015 g/ 5.9 g / 4.7 g, 3 pouches/carton, Rx only, Distributed by: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC# 0093-3560-26.",
      "product_quantity": "13,200 cartons",
      "reason_for_recall": "Defective container: potential for non-sealed pouches which can lead to product leakage.",
      "recall_initiation_date": "20240702",
      "center_classification_date": "20240807",
      "termination_date": "20250428",
      "report_date": "20240814",
      "code_info": "Lot #S300542, exp. date June 30, 2025",
      "more_code_info": ""
    }
  ]
}