{
  "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": "2026-08-20",
    "results": {
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      "cfres_id": "190677",
      "product_res_number": "Z-0552-2022",
      "event_date_initiated": "2021-12-01",
      "event_date_created": "2022-02-02",
      "recall_status": "Terminated",
      "event_date_terminated": "2023-02-13",
      "res_event_number": "89165",
      "product_code": "LIQ",
      "k_numbers": [
        "K852969"
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      "product_description": "Premier Rotaclone, Rx only",
      "code_info": "Model Number: RID696004, Lot Number 696004N116, Expiration Date 01/12/2023",
      "firm_fei_number": "1417592",
      "recalling_firm": "MEDLINE INDUSTRIES, LP - Northfield",
      "address_1": "3 Lakes Dr",
      "city": "Northfield",
      "state": "IL",
      "postal_code": "60093-2753",
      "additional_info_contact": "Karin Johnson\n866-359-1704",
      "reason_for_recall": "Product stored incorrectly in temperature controlled setting instead of refrigeration.",
      "root_cause_description": "Process control",
      "action": "Medline notified consignees on 12/01/2021, via first class mail letter titled URGENT RECALL NOTIFICATION. Customers were instructed to immediately check stock for affected product, quarantine any affected product on hand, complete and return the response form indicating product destroyed, and notify customers if the product was further distributed.  \n\nAn amended customer letter was sent on 12/17/2021. The explanation of the issue was updated. Instructions remained the same.",
      "product_quantity": "34 units",
      "distribution_pattern": "US Nationwide distribution in the states of California and Massachusetts.",
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        "device_name": "Enzyme Linked Immunoabsorbent Assay, Rotavirus",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.3405",
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}