{
  "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": "Allegan",
      "state": "MI",
      "country": "United States",
      "classification": "Class II",
      "openfda": {
        "application_number": [
          "M013"
        ],
        "brand_name": [
          "RUGBY CHILDRENS ACETAMINOPHEN"
        ],
        "generic_name": [
          "ACETAMINOPHEN"
        ],
        "manufacturer_name": [
          "Rugby Laboratories"
        ],
        "product_ndc": [
          "0536-1321"
        ],
        "product_type": [
          "HUMAN OTC DRUG"
        ],
        "route": [
          "ORAL"
        ],
        "substance_name": [
          "ACETAMINOPHEN"
        ],
        "rxcui": [
          "307668"
        ],
        "spl_id": [
          "d7ac78ac-7c67-4a15-910e-fb6efbde3ff4"
        ],
        "spl_set_id": [
          "304a9aa2-9198-44ca-8627-d41b84ec6cbf"
        ],
        "package_ndc": [
          "0536-1321-97"
        ],
        "is_original_packager": [
          true
        ],
        "unii": [
          "362O9ITL9D"
        ]
      },
      "product_type": "Drugs",
      "event_id": "88905",
      "recalling_firm": "Perrigo Company PLC",
      "address_1": "515 Eastern Ave",
      "address_2": "",
      "postal_code": "49010-9070",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Nationwide in the USA",
      "recall_number": "D-0581-2022",
      "product_description": "Children's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle, Distributed by: Rugby Laboratories, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152.  NDC: 0536-1321-97",
      "product_quantity": "4,992 bottles",
      "reason_for_recall": "CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.",
      "recall_initiation_date": "20211026",
      "center_classification_date": "20220223",
      "termination_date": "20230929",
      "report_date": "20220302",
      "code_info": "Batch: 1BK0960, Exp 12/31/2022",
      "more_code_info": ""
    }
  ]
}