{
  "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": "2026-07-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Richmond",
      "state": "VA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "NDA022015"
        ],
        "brand_name": [
          "MIRALAX"
        ],
        "generic_name": [
          "POLYETHYLENE GLYCOL 3350"
        ],
        "manufacturer_name": [
          "Bayer HealthCare LLC."
        ],
        "product_ndc": [
          "11523-4357",
          "11523-7268",
          "11523-7234",
          "11523-7341"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "POLYETHYLENE GLYCOL 3350"
        ],
        "rxcui": [
          "876193",
          "876195"
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        "spl_id": [
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        "spl_set_id": [
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          "11523-7268-8",
          "11523-7268-7",
          "11523-7268-4",
          "11523-7268-9",
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          "11523-7234-2",
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          "11523-4357-5",
          "11523-4357-2",
          "1152372340"
        ],
        "is_original_packager": [
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        "upc": [
          "0041100820716",
          "0041100564542"
        ],
        "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"
        ]
      },
      "product_type": "Drugs",
      "event_id": "90553",
      "recalling_firm": "Mckesson Medical-Surgical Inc. Corporate Office",
      "address_1": "9954 Maryland Drive",
      "address_2": "Deep Run Iii Ste. 4000",
      "postal_code": "23233",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA.",
      "recall_number": "D-1319-2022",
      "product_description": "Miralax (Polyethylene Glycol 3350), Powder for Solution, Osmotic Laxative, 30 Once-Daily Doses, Net WT 17.9 OZ (510 g) bottle, Bayer Healthcare Pharmaceuticals, NDC 11523-7234-4.",
      "product_quantity": "67 bottles",
      "reason_for_recall": "CGMP Deviations: products were stored outside the drug label specifications.",
      "recall_initiation_date": "20220629",
      "center_classification_date": "20220805",
      "termination_date": "20240213",
      "report_date": "20220817",
      "code_info": "Part# 11523723404",
      "more_code_info": ""
    }
  ]
}