{
  "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": "2026-09-20",
    "results": {
      "skip": 0,
      "limit": 1,
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  "results": [
    {
      "cfres_id": "214210",
      "product_res_number": "Z-2012-2025",
      "event_date_initiated": "2025-06-11",
      "event_date_posted": "2025-06-23",
      "recall_status": "Open, Classified",
      "res_event_number": "97007",
      "product_code": "LFD",
      "k_numbers": [
        "K234015"
      ],
      "product_description": "Caphosol Artificial Saliva (32 doses sachet box). 64 x 15 mL sachets aqueous solution\n(32 sachets Solution A Phosphate, 32 sachets Solution B Calcium)",
      "code_info": "UDI-DI: 5060146293129. Lot Numbers: 001U002U, 001U002UA. Expiration 2026-10",
      "firm_fei_number": "3027554269",
      "recalling_firm": "RECORDATI RARE DISEASES INC.",
      "address_1": "440 Us Highway 22 Ste 205 440 Us Highway 22",
      "address_2": "Ste 205",
      "city": "Bridgewater",
      "state": "NJ",
      "postal_code": "08807-2477",
      "additional_info_contact": "Ailyn Abin\n908-236-0888",
      "reason_for_recall": "Out of specification stability test result for the Caphosol B solution from process validation lots",
      "root_cause_description": "Device Design",
      "action": "Recordati Rare Diseases Inc. notified consignees on about 06/11/2025 via emailed letter.  Consignees were instructed to examine inventory for affected lots, discontinue using, dispensing and distributing the affected lots, and promptly return any inventory.  Consignees were also instructed to complete and return the Recall Response Form as well as notify consignees if the affected lots were further distributed.",
      "product_quantity": "3,754 boxes (120,128 doses)",
      "distribution_pattern": "Worldwide - US Nationwide distribution in the states of GA, OH, TN, TX, VA and the countries of Germany, France, Italy, Portugal, Spain, Sweden, United Kingdom.",
      "openfda": {
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          "K091419",
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          "K024148",
          "K203567"
        ],
        "device_name": "Saliva, Artificial",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "U",
        "pma_number": [
          "P790016"
        ],
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