{
  "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": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "48864",
      "product_res_number": "Z-0189-2007",
      "event_date_initiated": "2006-09-28",
      "event_date_posted": "2006-11-16",
      "recall_status": "Terminated",
      "event_date_terminated": "2012-05-21",
      "res_event_number": "36531",
      "product_code": "NQX",
      "product_description": "Doc-U-Dose Prescription Management System, Item 8-PKIT.  The product is packaged and distributed in cartons.  Each carton contains 1,000 sets of four packets or 4,000 individual packets per carton.",
      "code_info": "Carton numbers:  16 through 39 were subject to recall.",
      "firm_fei_number": "3005029365",
      "recalling_firm": "Eatonform Inc",
      "address_1": "2280 Arbor Blvd",
      "city": "Dayton",
      "state": "OH",
      "postal_code": "45439-1522",
      "additional_info_contact": "937-298-3408",
      "reason_for_recall": "The poly film may separate along the sealed seams of the packets of the Doc-U-Dose Prescription Management System causing the medications to unintentionally fall out of the packets prior to delivery to patient/consumers.",
      "root_cause_description": "Other",
      "action": "The firm issued recall notifications which were sent via UPS overnight delivery to all of their pharmacy customers on 9/28/2006. In their recall notification, the firm requests that the customers: 1) Cease using and distributing all Doc-U-Dose packets identified with the recalled carton numbers [instructions are provided as to how to identify the carton number]; 2) Segregate and secure all Doc-U-Dose packets identified with the suspect carton numbers [16 - 39 inclusive] or any packets from open cartons bearing those numbers; 3) Complete the attached Recall Verification Form which requests information concerning whether or not the customer(s) have any of the suspect product which they will be returning and the quantity of product to be returned; and provide the signature, title, and date of completion of the form by the individual responsible for carrying out the recall action [According to the recalling firm's instructions, the Verification Form is to be returned to Eatonform by fax or E-mail , no later than 3 business days following the receipt of the recall notification. Lastly, a toll-free no. is provided and the customer(s) is asked to call the firm's Packet Return Center and obtain instructions for returning any of the packets found on-hand [at the recalling firm's expense] and  to return all packets to Eatonform as instructed.",
      "product_quantity": "24 cartons [24,000 sets of four packets each]",
      "distribution_pattern": "Nationwide.",
      "openfda": {
        "k_number": [
          "K101879",
          "K243625",
          "K070462",
          "K162444",
          "K243070",
          "K112937",
          "K102740",
          "K120138",
          "K033415",
          "K132822",
          "K093346",
          "K191742",
          "K130894",
          "K100822",
          "K190771",
          "K133605",
          "K080837",
          "K112424",
          "K132468",
          "K091409",
          "K082140",
          "K142721",
          "K042357",
          "K071026"
        ],
        "registration_number": [
          "1550222",
          "3004141078",
          "3007420875",
          "1119779",
          "3004530258",
          "9610126",
          "2024800",
          "2243471",
          "3003795116",
          "3016838963",
          "3003030793"
        ],
        "fei_number": [
          "1550222",
          "3004141078",
          "3002806559",
          "3007420875",
          "1119779",
          "3004530258",
          "2024800",
          "2243471",
          "3003795116",
          "3016838963",
          "3003030793"
        ],
        "device_name": "System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen",
        "medical_specialty_description": "Microbiology",
        "regulation_number": "866.1640",
        "device_class": "2"
      }
    }
  ]
}